How to Master Traceability in Medical Device Development

As an engineer in the medical device industry, you’re tasked with creating innovative products that are both safe and effective. However, this core mission is often overshadowed by the immense pressure of regulatory compliance and documentation. As technology advances and products get more complex, that task gets even more complicated. Managing traceability between thousands of requirements, risk items, and test activities can feel like a “paperwork” burden that pulls you away from what you’d rather be doing: designing and testing new products.

This article offers a practical guide to transform traceability from a time-consuming chore into a strategic advantage. We’ll explore how to build a robust traceability model that not only satisfies regulators but also helps you build better, safer products faster.

TL;DR: Stop treating traceability as an end-of-project scramble. By implementing a single source of truth with Live Traceability™, you can connect requirements, risks, and tests in real-time. A modern platform like Jama Connect^® automates this process, helping you identify gaps early, reduce rework, and free up your team for more efficient product development.

The High Cost of Inefficient Traceability

When traceability is managed with disconnected documents and spreadsheets, it becomes a significant bottleneck. This manual approach is not just inefficient; it introduces substantial risks that can derail a project and kill the team’s morale. For complex medical devices, the consequences of poor traceability are severe:

• Project Delays: Manually creating and updating traceability matrices consumes hundreds of hours, often at the end of a project that results in pushing back launch dates.
• Compliance Risks: Incomplete or inaccurate traceability is a common reason for audit findings and can jeopardize FDA submissions and technical file reviews under the EU MDR.
• Increased Rework: Without a clear line of sight between requirements and tests, design changes can have unforeseen impacts, leading to costly rework late in the development cycle.
• Reduced Innovation: Engineers spend valuable time on administrative tasks instead of focusing on design, testing, and innovation.

The key takeaway: Treating traceability as a final-step documentation exercise is a high-risk strategy. The true cost isn’t just the time spent on paperwork, but the project delays, compliance failures, and missed opportunities that result from it. You can assess your own risk by taking a Requirements Traceability Diagnostic.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

How-To: Best Practices for Ensuring Medical Device Traceability

To move from a reactive to a proactive approach, you need to integrate traceability into the fabric of your development process. Here are four actionable steps to make that happen.

Step 1: Establish a Single Source of Truth

The foundation of effective traceability is a centralized platform where all product development data resides. When requirements, risk analysis, and test cases live in a single system, you eliminate the confusion and errors caused by separate documents.

A single source of truth ensures that every team member—from systems engineering to quality assurance—is working with the most current and approved information.

• Benefit: Creates consistency and provides a complete, auditable record of your design history.
• Impact: Reduces miscommunication and errors, ensuring all teams are aligned.

Step 2: Implement Live Traceability™

A static, manually created traceability matrix is outdated the moment it’s finished. Live Traceability, in contrast, creates a dynamic, real-time map connecting every requirement to its corresponding risks and test cases.

With Live Traceability, you gain instant visibility into the health of your project. If a requirement changes, you can immediately perform an impact analysis to see which downstream requirements, risk mitigations, and test items are affected.

• Benefit: Allows you to identify and address gaps in coverage early in the process.
• Impact: Drastically reduces audit preparation time and minimizes the risk of missing critical connections.

Step 3: Integrate Risk Management into Your Workflow

For medical devices, traceability isn’t just about connecting requirements to tests; it’s about proving that every potential hazard has been identified, analyzed, and mitigated. This is a core expectation of standards like ISO 14971.

By managing risk within the same platform as your requirements, you can directly link risk control measures to the design requirements that implement them. This creates a closed-loop process that demonstrates comprehensive risk management.

• Benefit: Ensures product safety is a continuous focus that woven into all project milestones, not a separate, check-box activity.
• Impact: Builds a safer, more reliable product and provides clear evidence of compliance for regulators.

Step 4: Streamline Collaborative Reviews and Approvals

Formal design reviews are a critical part of the development process, but they can be slowed down by manual feedback cycles via email or comments in disjointed documents. A modern platform streamlines this with a dedicated review center.

This allows stakeholders to comment, vote, and approve items in a structured, collaborative environment. All feedback is captured in one place, creating a clear and permanent audit trail of every decision.

• Benefit: Accelerates feedback loops and decision-making.
• Impact: Ensures that all approvals are documented and traceable, strengthening your Design and Development File.

From Burden to Benefit with Jama Connect

Implementing these best practices is far simpler with a purpose-built tool. Jama Connect is designed to help medical device teams master traceability and accelerate efficient product development.

By providing a single platform with Live Traceability, integrated risk management, and collaborative review workflows, Jama Connect helps you build your traceability matrix as you work. This transforms it from a document you create at the end of a project into a powerful, real-time tool you use throughout the project.

Customer success stories highlight the impact. For example, Dexcom achieved a 60% improvement in systems engineering efficiency by using Jama Connect to manage its complex requirements. Similarly, Vave Health significantly reduced the time spent on traceability matrices, accelerating its development and path to FDA clearance.

The most important benefit: Jama Connect empowers engineers to focus on what they do best—designing and building life-changing medical devices—by turning the “paperwork” of traceability into an automated, value-adding process.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

FAQs: Medical Device Traceability

Q: What is a traceability matrix in medical device development?
A: A traceability matrix is a document or table that demonstrates the relationships between user needs, design inputs (requirements), design outputs (specifications), risk control measures, and verification and validation activities (tests). While traditionally created in spreadsheets, modern solutions like Jama Connect provide Live Traceability, which is a dynamic, real-time view of these connections, making it far more accurate and less time-consuming to manage.

Q: How does traceability help with FDA and EUMDR compliance?
A: Regulatory bodies like the FDA (under the new QMSR) and the EU (under MDR) require manufacturers to prove that their device is safe and meets all specified requirements. A complete traceability record is the primary evidence used to demonstrate this. It shows auditors that every requirement has been tested, every risk has been mitigated, and the entire development process was conducted under a state of control.

Q: Can we integrate Jama Connect with our existing engineering tools?
A: Yes. Jama Connect is designed to serve as the central hub for requirements and risk management while integrating with other best-of-breed tools in your ecosystem, such as Jira, Azure DevOps, and various testing suites. This creates a connected toolchain that provides end-to-end traceability without forcing your teams to abandon the specialized tools they rely on.

Take Control of Your Traceability Process

Stop letting manual traceability processes create bottlenecks and introduce risk. By adopting an integrated approach, you can pass audits with confidence, accelerate your time-to-market, and empower your engineers to focus on innovation.

Ready to see how you can transform your product development process? Schedule a personalized demo to learn more about Jama Connect for Medical Device Development.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.

In this blog, we recap a section of our recent webinar, “Best Practices for Live Traceability™” – Click HERE to watch it in its entirety.

Drive Better Outcomes Using Live Traceability™

Managing product development across complex teams and toolchains can result in incomplete traceability, delayed deliveries, and costly rework. But it doesn’t have to.

In this session, you’ll learn how Jama Connect^® enables engineering teams to achieve Live Traceability™ as a natural part of their daily workflows — unlocking faster, more efficient product development.

What You’ll Learn:

• Experience Live Trace Explorer™: Visualize and investigate the full impact of changes across your entire product lifecycle.
• Built-In Traceability: Learn how everyday engineering works within Jama Connect to builds and maintain end-to-end traceability.
• Speed Up Change Impact Analysis: See how structured data supports faster, more informed decisions.
• Boost Quality and Coverage: Ensure complete test coverage, mitigate risk, and improve delivery timelines

The Above Video Is A Preview – Click HERE To Watch The Entire Webinar

VIDEO TRANSCRIPT PREVIEW

Jakob Khazanovich: Good morning, good afternoon, and good evening to everyone joining us. Today, we’re going to explore Live Traceability, what it is, why it matters, and how you can achieve it with Jama Connect. My name is Jakob, and I’m a Senior Solutions Consultant at Jama Software. My job is to help customers be successful in their product development goals by using Jama Connect. My expertise is in systems engineering for the medical device industry, and I’ve also had roles in test and quality engineering. My goal today is to give you clear, practical insights into how traceability works within Jama Connect to help you meet regulatory compliance requirements, ensure complete development and testing coverage, and streamline Change Impact Analysis. We’ll start with a brief introduction to Jama Connect, and then I’ll walk you through what complete traceability looks like in action. We’ll see how this ideal state strengthens development and sustaining engineering practices, and I’ll share the steps to get there. We’ll wrap up with a short Q&A so you can get your questions answered.

So when we talk about capturing data for complex product development, we all know that data in our organizations exists in many different forms. We have documents, we have Excel sheets, those Excel sheets contain rows, and all of those rows have data around a certain requirement or a certain artifact. Now, that’s all fine, but usually, documents or requirements are not so useful in and of themselves. What we actually are after is complete information for our system. Where did our requirements come from? What elements in the design implement that requirement? Did we test to make sure the requirement is met? And so on. When information is fragmented, whether that is requirements, testing, work management items, system architecture, risk management, product management, regulatory, or any other commonly siloed function, this increases risks to the product and end user, increases time to develop, and increases development costs.

What we are looking at here is a typical V-model of development. We have design inputs down the left side, design outputs on the bottom, and testing up the right-hand side. These are typically the steps in a product development effort. Now, this slide highlights a study finding that many will find intuitive. The earlier in the development process the changes are implemented, the less costly it will be to implement that change. But I still found the number staggering. On average, it costs 110 times more to make a change once you are in the design validation phase of your development compared to early on in the requirements definition phase. This hammers home the importance of thorough requirements identification, traceability from requirements to every downstream element in the development, and the need for a streamlined way to evaluate and to implement changes when necessary.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

Khazanovich: This is a typical development ecosystem. This structure often leads to negative outcomes, as described in the previous slides. When teams develop documents and designs and siloed tools, then identification of coverage gaps, inadequate change management, failure to assess and manage risk proactively, and countless hours and days building trace matrices are practically expected. Jama Connect solves these challenges and more. Complete information is created by building trace relationships and structure around individual artifacts in the system. When you do that, you basically empower your users to find any information and context to complete their work in the most accurate and efficient way possible. This is done in real-time, creating full traceability as a byproduct of engineering work rather than as a retrospective effort. We call it Live Traceability.

Now, you can go a step further than just traceability, and that would be understanding where decisions come from. You want to capture the why of a change. Why did we change the requirement or the occurrence estimate for a particular risk evaluation? This is invaluable information when changes are being considered or implemented in the product in the future. We will briefly discuss how Jama Connect supports documenting decisions and ensuring that institutional knowledge is minimized as much as possible.

Of course, teams do not develop complex systems in their own specific habitats. They are connected to a greater ecosystem, the many, many connections around them that have input on decisions and have input on those connections. So, engineering partners, customers, and other departments within the company can be invited to take part in that process and must be considered in development and change management processes. In the latter half of this presentation, we will show how we can actually relate information and what is involved in building those relationships. And once we have those relationships, what leverage, what value, and benefit can we get out of those relationships? What kind of higher-level perspective do they give us?

Traceability helps us confirm that we actually built the product we intended to and that every identified risk has been addressed and controlled. Second, embracing change. Products and requirements evolve. Traceability lets us quickly see what parts of the system are impacted by change so we can manage it without introducing new risks or gaps. Next, validation and verification. We need objective evidence that our product meets requirements and user needs. Traceability also lets us confirm that the risk control measures we put in place are truly effective. Live Traceability is the gold standard in product development. It allows you to see the status of your development effort in real-time and enables many benefits that we will later discuss. In Jama Connect, the easiest way to visualize your live traceability is with the Live Trace Explorer, so let’s jump into the tool and see what our gold standard looks like.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Khazanovich: Now, we are in Jama Connect, and we can see the Live Trace Explorer in action. The first thing we can see in the upper right corner is the overall traceability score, which is the number of relationships created, divided by the total expected relationships, based on your defined Traceability Information Model (TIM). This has been filtered down to only consider the relevant and expected trace relationships for this particular project. I can see a nice green symbol in the upper right corner, which, as I remember from my business school days, means that things are going well in my product development. Throughout the development of the product, I saw this score increase from red to yellow to green, with the percentage associated as the traceability was created and completed. Going through the various tiles, here we can see the different sections of the explorer tree and have a more detailed view of which relationships have been created.

For example, I can see that all of my user needs are traced to system requirements, and all of my user needs are traced to validations. Additionally, I can see what percentage of my relationships are valid relationships, meaning that they’re not suspect links. We will discuss suspect links a bit more later. The Live Trace Explorer mirrors the traditional V-model layout, with design inputs on the left-hand side, testing on the right-hand side. I can see that 100% of my user needs are traced to validation test cases, and all of those test cases are included in test plans. I can see a summary as well of any open conversations, which will clue me in to why traceability may be missing or any outstanding questions that the team is trying to align on. If I want to get any additional details on a specific tile, I can click on the desired trace pair, for example, from user needs to requirements, and a new window will open showing my Trace View for the relationship pairing. Within the Trace View, I can then navigate one-by-one and get a preview of my items, like user needs and system requirements.

So, in the Live Trace Explorer, we mentioned the Trace Score™, and you’re probably wondering, how can we compare or calculate a trace score when there are many different ways to create Traceability Information Models, depending on your project and industry? As mentioned previously, the Trace Score is calculated by taking the number of established relationships among model elements, divided by the number of expected relationships among model elements, as specified by the project’s traceability model. Looking at the left diagram here, we can understand that for a single requirement, in this example, there are three expected relationships: one relationship to the user need, one to the subsystem requirement, and one to a verification. In this example, we are missing the trace to verification, so out of the three total traces that we’re expecting, we only have two of those created, resulting in a 66% Traceability Score.

Now, if we look at multiple requirements, let’s say there are three requirements and each of them have a trace to a subsystem requirement, but maybe only one of them is traced to a user need and only two are traced to verification items, now we can see that overall, for those three requirements, we have six of the traces created out of the nine that we’re expecting based on our model. On the right side, you can see how this would be scaled up to the entire project level. We’re going to look at every item that’s created, how many items are expected to trace to it, and then how many items are actually traced to it, and we’re going to look at that as a total for all items. Here, we see 101 expected relationships, 73 of which are established, and that leads to a 72.3% Traceability Score.

To Watch the Entire Webinar, Visit:
Best Practices for Live Traceability

In this blog, we recap our recent Whitepaper, “Extending End-to-End Traceability into the Semiconductor Design Cycle.”

Extending End-to-End Traceability into the Semiconductor Design Cycle

Modern semiconductor design is a high-stakes, high-complexity endeavor. With fabless semiconductor companies evolving rapidly & tackling increasing design challenges, effective requirement traceability across the entire design lifecycle has never been more critical. Traditionally limited to the later stages of development, traceability now demands an upstream extension, covering Electronic Design Automation (EDA) and verification tools.

Why does this matter? Extending requirement traceability earlier into the semiconductor design cycle doesn’t just minimize errors; it ensures efficiency, reduces costs, and bolsters compliance. This whitepaper explores why integrating traceability into EDA tools benefits chip and system-on-chip (SOC) projects and how companies can set themselves up for success.

Why Extend Requirement Traceability to EDA Tools?

Manage Complexity Across Distributed Teams

Fabless semiconductor companies and Integrated Device Manufacturers (IDMs) increasingly rely on globally distributed teams and specialized domains for system, hardware, and software design. This decentralization makes collaboration more challenging, and critical requirements may get lost in translation.

Without clear traceability, common pain points include:

• Miscommunication about design intent across teams
• Misinterpretation of product requirements
• Testing against outdated requirements
• Uncertainty and risks in IP reuse, especially when lineage and design intent are undocumented

By extending the reach of traceability into EDA tools and workflows, organizations can create a direct link between system requirements, IP blocks, design intent, and test benches. This reduces the risk of potential miscommunication & ensures that every design artifact aligns with higher level business goals.

Identify Risks Early in the Design Cycle

Simulation and Verification capabilities in an EDA tool are critical checkpoints for ensuring alignment between architectural design and performance requirements. When connected to traceability frameworks, these tools elevate quality assurance and minimize risk.

Through such an integration, teams can:

• Detect and correct inconsistencies in architecture, performance, and design constraints before tape-out
• Proactively identify gaps in requirements coverage
• Continuously monitor power, performance, and area (PPA) metrics as designs evolve
• Increase chances of first silicon success

By tying simulations and verifications directly to requirements, companies preserve agility while safeguarding against expensive last-minute failures.

Lay the Foundation for Generative AI Integration

From defect prediction to automated generation of requirements and test cases, AI is transforming the semiconductor industry. To fully leverage AI’s potential, organizations need well-structured data from across their lifecycle that is traceable. This includes EDA tool and serves as fuel for AI-driven insights such as:

• Defect predictions and design inconsistencies
• Automated requirement creation and test case generation
• Robust analytical capabilities with intelligent suggestions for coverage gaps and test improvement

This end-to-end integration is essential for companies aiming to improve the structure of their engineering data so it can be used as a data pipe to feed other AI/ML projects and initiatives.

RELATED: Join the Leaders Choosing Jama Connect^® for Semiconductor

Avoid Failure Despite Mature Processes 

Even the most advanced requirements management processes can fail to bridge the gap between early design work and high-level product goals. This disconnect can result in overruns on cost and time while missing performance or functional
targets.

Without tightly linking decisions in early-stage EDA tools to requirements, organizations face:

• Misaligned timing, throughput, or power targets during critical milestones
• Slow root cause analysis when performance benchmarks are missed

Extending traceability ensures visibility into how each design decision affects product goals, enabling rapid adjustments and informed decision-making.

Facilitate Efficient Change Impact Analysis

Semiconductor design is an iterative process where late-stage requirement changes can ripple across RTL, DFT, and verification layers. Effective traceability enables teams to propagate changes efficiently and assess downstream impacts in real-time.

When EDA tool outputs, constraints, and simulations are part of the traceability chain:

• Impact analysis for system requirement changes becomes seamless
• Verification teams can identify affected test plans and test constraints instantly
• Regulatory compliance processes become auditable and efficient

This end-to-end integration is essential for companies aiming to improve the structure of their engineering data so it can be used as a data pipe to feed other AI/ML projects and initiatives.

Ensure Regulatory Compliance and Certification

Whether it’s automotive (ISO 26262), aerospace (DO-254), or medical devices, safety-critical industries demand rigorous traceability and accountability.

By extending traceability into EDA ecosystems, semiconductor companies can provide proof of:

• How requirements were implemented in RTL and verified through simulations
• Continuous validation of system-level intents

This level of transparency is crucial for certification in highly regulated industries, ensuring customer and stakeholder confidence while avoiding compliance gaps.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Semiconductor

Practical Approach to Achieving End-to-End Traceability

Here’s how fabless semiconductor companies can implement a traceability framework that extends across the design, simulation, and verification layers.

System Layer: Where it All Begins

End-to-end traceability starts with a solid foundation at the system layer. This stage focuses on managing requirements and maintaining a clear connection between what the product must deliver and how those goals translate to system functions.

Key Takeaways:

• Jama Software serves as the traceability hub to ensure alignment across teams
• Model-Based Systems Engineering (MBSE) Tools such as Cameo enable detailed system modeling
• Product Lifecycle Management (PLM) Tools like Windchill help track complete product lifecycles

Key Artifacts:

The artifacts at this stage include product requirements, architecture models, and functional and non-functional requirements such as PPA (power, performance, area) metrics.

Traceability Links:

High-level requirements are seamlessly linked to system functions and verification criteria, ensuring no gaps between product expectations and system capabilities.

Design Layer: Bridging Hardware and Software

Once system requirement baselines are established, the focus shifts to the design layer, where the intricate dance between hardware and software development takes place.

Key Tools and Resources:

• RTL Design Software, like Synopsys VCS, simplifies design processes
• Software Tools, such as Jira, streamline task management
• Prototyping Tools, including Xilinx Vivado, assist with early-stage testing

Key Artifacts:

The main outputs here are HDL (Hardware Description Language) modules, design specifications for hardware and software, and integration plans to bring it all together.

Traceability Links:

At this stage, system requirements feed directly into design specs, which flow into HDL and software modules to uphold interconnected traceability.

Download the full whitepaper to learn more about the following topics:

• EDA Toolchain Integration Layer: Simulations at the Core
• Verification and Validation Layer: Testing the Foundation
• Analytics and Decision Support Layer
• Transforming Requirement Traceability with Jama Software
• Set Up Your Semiconductor Design for Success

DOWNLOAD THE ENTIRE WHITEPAPER TO LEARN MORE:
Extending End-to-End Traceability into the Semiconductor Design Cycle

In this blog, we recap our webinar, “Improve Traceability and Enhance Coverage with Live Trace Explorer™”

Improve Traceability and Enhance Coverage with Live Trace Explorer™

Engineering teams today face growing challenges in maintaining requirement coverage, managing risks, and making informed, data-driven decisions,  all while working with siloed tools and tight deadlines. Simply meeting the minimum traceability requirements isn’t enough to stay competitive.

Live Trace Explorer™ helps teams visualize end-to-end trace relationships, identify gaps, validate coverage, and ensure quality in real time. With advanced filtering capabilities, you can focus on what matters most to keep your projects on track, compliant, and aligned with traceability best practices.

In this session, host Francis Trudeau will show you how Live Trace Explorer enables engineering teams to visualize trace relationships, validate coverage, pinpoint gaps, and ensure quality, all in real-time. You’ll also learn how advanced filtering capabilities help you focus on what matters most, while aligning your traceability practices with industry best practices.

What You’ll Learn:

• The vision behind Live Trace Explorer and its evolution
• How to use filtering to enhance clarity, control, and support traceability best practices
• Strategies for leveraging traceability to manage risk and ensure compliance
• This is your chance to gain actionable insights, contribute to the evolution of traceability tools, and stay ahead in managing risk and compliance.

VIDEO TRANSCRIPT

Francis Trudeau: My name is Francis Trudeau, and I’m a Product Manager at Jama Software. I’m also a curious Scout leader who thrives in the great outdoors and enjoys a good story. Now, picture me as a hiker standing at the foot of a mountain, and that mountain represents the path of development, the climb towards a vision that guides our every step. My specific role is to give you a clearer, elevated view, helping you navigate your projects from start to finish, measuring progress, and managing risks along the way. The summit of the mountain represents that ideal, managing the development process through data. In other words, making decisions based on available information, think metrics, graphics, trend lines, dashboards, etc. But like any true vision, it’s not just a destination. It’s a challenge. Can we even get there? Is there a taller peak hidden behind this one? That mystery is part of the adventure.

In today’s webinar, I invite you to tag along on this journey. I’ll show you the progress we’ve made so far, offer a glimpse of the path ahead and share how you can contribute to making this vision a reality. So we are set for a journey, and our first milestone along the way is the Live Trace Explorer, which is essentially a visual dynamic representation of the V-Model for evaluating coverage, addressing gaps and managing associated risks. Focusing on the diagram, each tile represents a component or set connected with trace paths. These paths are gray if there are no relationships between the items in adjacent tiles and they turn green and red to indicate the number of valid or suspect relationships between those tiles.

On the right side, the verifications and validations branch shows the number of test cases linked to items within the container on its left no matter where they appear in the project. At the bottom of each tile, you’ll find a metric representing the ratio of those test cases included in a test plan.

On the requirements side, the top part of each tile displays stats including the number of items by type and any open conversations. In the bottom half, you’ll find coverage metrics, essentially the ratio of existing relationships to expected ones as defined by the Traceability Information Model.

Overall, the Life Trace Explorer is meant to expose the coverage completeness as the ratio of existing over expected relationships and a measure of the validity of relationships by exposing a metric of suspect relationships between related items included in two adjacent tiles. By creating a diagram for a simple project, one can easily get a big picture of a project, spot gaps, and keep track of progress. Beautiful, isn’t it? Are we there yet?

Well, not quite. As we catch our breath and take in the view, it becomes clear that the view, while impressive, is a little foggy. We’ve reached a breathtaking lookout. The elevated view is structured, informative, even beautiful, but for many of the customers we’ve consulted, the information still feels cloudy. Yes, the coverage percentage and suspect indicators are valuable. They give us a sense of direction, but there’s a key limitation. The Life Trace Explorer currently measures everything without distinction. In real projects, not every item should count towards coverage. To get a metric that truly reflects reality, we need the ability to focus, to filter in only the relevant items and filter out the noise. Only then can we sharpen the view and get a clearer, more meaningful measure of completeness.

RELATED: Requirements Traceability Benchmark

Trudeau: Let’s take a look at a few real examples customers have shared with us. The first one is about filtering out items that shouldn’t be included in coverage. For instance, many teams keep items in their project that were originally considered but later rejected. They’re still useful for historical context, but they don’t need to be part of the coverage calculation. The same goes for draft items. They’re still in progress and not ready to be measured yet.

The second example is about narrowing the scope. Sometimes teams want to measure coverage or track suspect links only for a specific slice of the project. A good example is when using prioritization methods like MoSCoW, where a team may only want to focus on must-have items.

Another example is when tailoring views for different stakeholders, say admins, primary users, or partners, and only showing what’s relevant to each group. Now, Jama Connect^® is highly configurable, so these are just a few common examples. What matters here is that the filtering we’ve added to the Live Trace Explorer works with any picklist field and only picklists for now. So with that in mind, let’s jump into Jama Connect and see how it works.

Here we are in the ACME demo project. The Traceability Information Model or TIM flows simply from left to right, starting with higher-level needs, then moving down to requirements and designs. Each of these is validated and verified by test items. It’s a straightforward setup that follows the logic of the V-Model.

To begin, we’ll generate a diagram for the entire project and open the Trace Score™ calculator so we can keep track of the metrics used in the calculation. Our first filter will focus on the design items. Right now, we have three designs, and the coverage is showing 66%. Let’s take a closer look. In our project, each design has a status chosen from a picklist: draft under review, approved or rejected. One of them is currently marked as rejected. We’re going to apply a filter to ignore rejected designs. To do this, open the configuration settings, open the configuration applied to the specification tiles, click the funnel icon to set the filter, set the rule using the picklist field for design status, in the second drop-down choose is not equal to, then select rejected, set the filter, and apply. We now have two items instead of three. Coverage for the items that matter is 100%, and the Trace Score is updated accordingly. Also, notice the funnel icon. It shows that a filter is now applied to this item type in this tile.

Next, let’s move to the requirements. At ACME, we use the MoSCoW method to prioritize them. Suppose we want to focus only on the must-have items. We’d apply a similar filter as we did for designs. Here we have four requirement items, but only one is marked as must. Back in the diagram, we follow the same steps to set the filter. Before I hit apply, you can probably guess the item count will drop to one, but watch what happens with the suspect and coverage metrics. We now notice a clear coverage gap with the designs. On the verification side, test cases are linked, but they’re not included in a test plan yet. As for the suspects, there are three needs pointing to this must requirement, and one of those needs has changed, which makes the relationship suspect.

For our last example, let’s look at those needs. Each one is tagged with one or more user groups. Let’s say we only want to measure the needs relevant to partners. We go back to the configuration panel. Since this is a multi-select picklist, our rule options are contains and does not contain. We choose the content and select a partner. Before I hit apply, pay attention to the suspect links, the test metrics, and open conversations. See that all these related metrics are refreshed to only consider information from filtered items.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

Trudeau: To wrap up, this configured filtered diagram gives us a Trace Score specifically for the partner’s needs, focusing on must requirements and excluding rejected designs. Finally, we can save this configuration, for example, as ACME for Partner, so we can return to it later.

That was a quick tour of how Live Trace Explorer filtering works, a simple, flexible way to sharpen your focus and configure what you actually want to measure. Now let’s talk about what’s next. Filters will be available to all cloud customers in Jama Connect 9.24 scheduled for release in the coming weeks. In July, Live Trace Explorer will be part of our customer-validated cloud rollout, and note that this version is based on Jama Connect 9.22, so filters won’t be included in that CBC release. For self-hosted customers, Live Trace Explorer with filtering will be available later this fall. Our team remains fully dedicated to the future development of Live Trace Explorer, and this includes further refinements on filters, specifically developing nested filters, supporting and or clauses for more than one filtering rule. Remember in the demo when I excluded rejected designs, what if I wanted to exclude draft or rejected designs? The nested filters will allow for this sort of logic.

Beyond these near-term improvements, we are exploring ideas inspired by customer feedback, ways to make Live Trace Explorer even more configurable and actionable. Driving action is about clicking a metric to drill into a filtered trace view, showing only items with missing coverage, suspect links or open conversations. Tailoring is about tailoring the diagram layout itself, hiding irrelevant tiles or reordering them for clarity or to reveal suspect status between different locations. We’re also looking beyond the diagram towards future metrics that can help you manage your projects with confidence.

When the team brainstormed avenues for the Live Trace Explorer, many possible metrics were envisioned. Trend lines over time to tell the story of your project and identify bottlenecks. Coverage gaps per item owner to visualize specific user. What about an item status breakdown? Is this worth monitoring? And what do you think of the relationship health for visualizing change and rework? Is a measure of aging for suspects interesting? What about test execution status? Not just test coverage? These are just a few examples, and of course, we’re always looking for more ideas, but the metrics that really matter are the ones aligned with your goals. I guess the question is, what do you want to manage? What do you want to measure?

Jama Connect is already helping teams bridge requirements and testing, but we want to support you further with insights that reflect your priorities, your goals, and your way of working, so here’s my invitation. Join us in this journey. If the idea of managing the development process through data resonates with you, if you’re excited about defining and evolving the right metrics, if you want a map and compass of your mountain climb, a way to see not just where you are but where you’re going, then let’s keep the conversation going. Reach out to your customer success manager, ask to connect with product management, and help shape the future of Live Trace Explorer and the tools that power your work.

WATCH THE ENTIRE WEBINAR HERE:
Improve Traceability and Enhance Coverage with Live Trace Explorer™

In this blog, we recap our recent webinar, “Eliminate Gaps and Risks with Proven Traceability Best Practices”

Eliminate Gaps and Risks with Proven Traceability Best Practices

Achieve Live Traceability™ Across Complex Development Lifecycles

Manufacturers across industrial, consumer electronics, and energy sectors are under constant pressure to build smarter, more complex systems all while meeting strict safety, regulatory, and performance requirements. As development processes span more tools, teams, and geographies, maintaining visibility across the entire product lifecycle becomes a real challenge.

Join Jama Software’s Yannick Selg to discover how Live Traceability and Digital Thread strategies can give your teams the visibility and confidence they need to deliver innovative, compliant products faster.

What You’ll Learn:

• Apply process best practices for end-to-end traceability in industrial manufacturing
• Use Digital Thread strategies to connect engineering, quality, and compliance teams
• Automatically detect gaps and risks in products and processes before they impact delivery

If your team is balancing complex requirements, specialized tools, and compliance demands, this webinar will show you how to stay ahead.

VIDEO TRANSCRIPT

Yannick Selg: Thank you very much. My name is Yannick Selg. I’m a Senior Solutions Architect here at Jama Software. I bring broad experience in PLM and ALM implementation, and I’m supporting our customers in the machinery, consumer electronics, and energy sectors here with all your technical questions and demos. And I’m looking forward to guiding you through our webinar today, talking a little bit about traceability. Let’s start by taking a look at our agenda for the webinar today. We have a lot of exciting content to cover. So as a first step, we’ll begin with a brief introduction where I will provide an overview of the potential impact of gaps in traceability and how these affect your organization’s and basically day-to-day project work. Next, we’ll dive into the concept of the digital threat, and I will explain what a digital threat is as well as its significance in product development nowadays and how it can enhance collaboration and data visibility across the product development lifecycle in your organization. We’ll also take a look at some key benefits and the impact of those benefits on the daily work.

Following that, we’ll talk about the importance of traceability and explore some key points for end-to-end traceability. I will also discuss the importance of traceability in product development and the key components that are involved in this traceability. Right after that, we will jump into a live demonstration. We will focus on identifying gaps and risks in the product development process when using Jama Connect^®. I’ve prepared some use cases which will give you an idea about the tools, the methods, and also the techniques that are available in Jama Connect for the detection of risks and gaps in traceability. And we will close out at the end with a Q&A session. This is your opportunity to also ask questions that you may have about a topic that we are covering today, but also any other topics regarding Jama Connect in general or regarding Jama Software, our organization.

Now let’s take a closer look at the impact of gaps in traceability. And oftentimes, we see the number one impact that we have is rework when we talk about gaps in traceability. Rework is a very significant factor in product development, and depending on which source we are looking at, it often consumes a substantial portion of the project budget and also the project time. So studies have shown that depending on which study you’re looking at, between 40 and 70% of a project’s budget is often allocated to rework and, for example, rogue development due to lack of, for example, traceability, but also numerous other factors. So this means basically half or, oftentimes, more than half of the budget is spent in correcting errors and making changes after the initial work is already completed. And we can also see that the amount of money that an error costs and rework costs increases exponentially throughout the entire life cycle of the product.

So, for example, if an error is initially detected during the development phase of your product, it’s far cheaper to fix, but looking forward, if this error goes into production, the costs can be astronomical to fix these errors. So, in order to avoid situations like this, traceability and the digital threat can be quite a good answer to this. Now, what does the digital threat provide? So the digital threat is, well, I would say basically a communication or orchestration framework that integrates data across the entire product life cycle. This means basically that the information from various stages of the development… Well, in the best case, all stages of development, like, for example, design, manufacturing, or testing, as well as maintenance, are connected together seamlessly. And by connecting this information from different stages of the development, the digital threat basically ensures that all the relevant data is accessible by the right people at the right time.

And this connectivity is crucial for maintaining consistency and accuracy also during your entire development process, and having all the information available, as I said, at the right time. And maybe the key benefits that I want to point out here of the digital thread are that it provides a broad visibility into the development process. So this basically means that you can see what is happening in your development process, and you can also see changes. So this visibility basically allows you to manage changes more effectively and ensure that modifications are tracked and the impact of these modifications is understood in the early stages of the product development process. So with this comprehensive view, your organization can make informed decisions and mitigate risks that are associated with these changes even before they occur. Now, what are the benefits of having these frameworks in place? I already talked about this on a high level, but I want to point out a couple of, well, specific things here, which we also see later on in Jama Connect.

So one of the key benefits of having the digital threat is, of course, the improved collaboration within the project, but also within the entire organization. With all the data integrated as shown before, team members from different departments and from different projects can access the same information, which is basically creating and supporting better teamwork and communication in the entire organization. And this enhanced collaboration obviously leads to more efficient problem-solving and decision-making processes across the project, but as I said, maybe also across the entire organization. Next, the digital threat also provides better data visibility and accessibility in the organization because the relevant data is all connected and it’s all visible in real time. So stakeholders can easily get this up-to-date use, and we will see this in Jama Connect later on as well. Having this digital threat enabled will basically allow you to get real-time updates on the status of your project. And this improved visibility ensures that everyone is basically always working on the latest data, which is reducing errors, especially about, for example, having delayed information flow throughout different silos.

RELATED: Overcoming Top Challenges in the Energy Storage Industry with Jama Software

Selg: And this is the third point that I want to talk about, and probably also the most important one, as you will see on the next slide. So, traditional product development is often done in fragmented parts and isolated teams, but the digital threat breaks those barriers down and connects data and teams, and promotes a more integrated and cohesive approach to the development of your products. And this reduction of the silos is what all the organizations are striving for because it leads to smoother workflows and an overall very collaborative environment with very efficient communication streams. Now this is something that we see a lot with our customers, and I guess this model is quite familiar to you. You can see a, I would say, V model-inspired approach, but all the departments that are responsible for the different levels in here like, for example, the initial requirements identification of stakeholder requirements is done by a department, the system requirements are identified by a different department, implementation is, again, done by different departments and also in different tools. Same thing for the verification side of the V modeling here.

So maybe your work process will differ from the V-model, but still we observe a lot of silos that are working with their own tools like, for example, Word here or Excel as a requirement identification tool, which we see a lot with our customers. We also see, for example, Jira for software development, or Windchill or Teamcenter as a PLM software for hardware implementation. And we see Jenkins for automated testing. So, Jama Connect really connects with all those best-in-breed tools. And what we do here is we will set up what we call live traceability across the entire V-model, and we will eliminate the silos that we have seen before. So you can see on the entire V-model that we have here, all the levels are connected to each other, and Jama Connect is providing Live Traceability™ across the entire lifecycle of the V-model here by including information bidirectionally from all the tools that we can see around here to make sure that we have the full traceability available in Jama Connect.

Now, let us discuss the importance of traceability in product development and why it is critical to the success of any project. Basically, traceability ensures that all the requirements that we have are met and verified or validated throughout the entire product lifecycle. So this means on all the levels of the V-model, for example, that we have seen before. This also means that every requirement is tracked from its birth, from the inception of the requirement through the implementation all the way to the testing at the other end of the V-model. And by maintaining this level of oversight, we can basically ensure that nothing is overlooked and that the final product also meets the specified requirements that we have had from the beginning. Another key aspect of this traceability is also the role of traceability in terms of compliance. Many industries have very stringent standards and regulations that they must follow, and traceability allows your organization to demonstrate this compliance by providing, for example, a clear audit trail that might be required by auditors, and you can show how requirements were managed and fulfilled, and also traced.

This is very critical for passing regulatory inspections and potentially avoiding legal issues at the end and liabilities when delivering a product. And last but not least, traceability also plays, of course, a very important role in enhancing the quality of your products by tracking requirements and the implementation of requirements as well, so extending the traceability out from the requirement space also in the implementation space allows us to identify potential gaps and risks very early in the development process. And this early detection basically is what allows us to address these issues before they even become major problems, which ultimately ensures a higher quality of products and reduces the likelihood of this costly rework that we have been talking about in the very beginning. Now I would like to talk a little bit about the key components of Jama Connect for successful traceability and how we can support in setting up traceability before we just jump into the demo, because these will be the topics that we will now see in Jama Connect.

So I have divided it in three major parts. The first topic that we’re going to talk about is the requirements part, which is the Trace View that supports your engineers in identifying risks and gaps in the daily work, but we also have the option to use the Live Tracer Explorer, which will monitor the traceability of the entire project in real time in a bird’s eye view and gives decision-makers a lot of information to work with regarding the current health and traceability of the entire project. The next topic that I would like to talk about is validation and verification. With the relationship settings and the traceability of Jama Connect, we are able to create so-called Quality Gates, which will allow us to monitor various issues that might occur, like, for example, having approved system requirements without having test cases assigned to them. This gives you the opportunity to get a live overview of critical decompositions in your project and act on them accordingly. And the third topic here is change management because we don’t only have traceability for a static system, but Jama Connect also allows us to manage change.

The first thing that we are going to take a closer look at here is the impact analysis, which supports us understand the risks and the potential impact of change before we actually perform the change. And we will also take a look at the control mechanism called Suspect Links, which supports to manage change efficiently across different levels and allows us to make sure that we do not forget any important points when a change has been performed and the changes are propagated throughout all the required levels. All right. Now let us take a closer look at Jama Connect and go through the creation of traceability. So in here, in Jama Connect, in the middle in our dashboard, we can see our traceability information model, which is basically the backbone of our requirements decomposition and which guides our engineers through the entire process. My system is a smart temperature control system, which is basically a thermostat that can be managed with your mobile phone. And here, we have an example picture how this object will look like that I will use for the demonstration today.

RELATED: Jama Connect for Robotics Datasheet

Selg: Now, when we look at the dashboard, we can see a traceability model that is, I would say, inspired by the V model. We have the stakeholder requirements on level one, we have the system requirements on level two, we have the subsystem requirements on level three, and we have an extended traceability in software with user stories, this will be used for our demonstration today, but we also have the possibility to have, for example, design descriptions which can be implemented in your hardware systems like, for example, PLM systems achieve the same effect. And we have the right-hand side of the V model with our subsystem verifications, system requirements, and ultimately our stakeholder validations in this case. So now from this user story, we have a link into Jira and the engineer would now work his daily practices. In Jira, would perform his daily task, the user story that we can see here is bidirectionally and continuously integrated with Jama Connect, so all the changes that we perform in Jira will be captured in Jama Connect and vice versa.

If the software engineer wants to understand the entire traceability and digital threat, he can jump with the click on the Jama Connect link, into Jama Connect, he will see the synchronized user story, and from here, he can open the Trace View and understand the decomposition of the user story all the way up through our decomposition process up to the highest level. So we can come from the user story one level up our subsystem requirement, which is decomposed from a system requirement, and ultimately, we are back at our remote control stakeholder requirement, which is the initial requirement that our user story is decomposed from. Now, this Trace View can be used on an individual level to perform daily activities as an engineer, but it provides far more than that. If we take a look at our second use case, we can now, for example, take a look at an entire set of system requirements and the Trace View is scalable and also supports taking a look at an entire set.

Now this comes in especially handy if you’re, for example, a Q&A engineer and you want to check the coverage of our system requirements with tests. So we can open the filter and filter for verifications against our system requirements, and Jama Connect will indicate a gap in coverage with a red exclamation mark. So, what we can do from here we can either create new verification cases or we can add coverage and link to already existing verification cases, either within our project or Jama Connect also supports cross-project referencing to create the coverage directly right here. Okay. As the next step, we want to understand what happens if change occurs after we already created and approved our requirements. To understand this, I have prepared a third use case where we going to take a closer look at our remote control stakeholder requirement. So I guess we all know the situation. We have been working on a product, and six months into the development process, stakeholders or customers are coming in and asking for changes of initial stakeholder requirements.

Jama Connect allows us to perform an impact analysis at every stage of the development, and due to the traceability that we have established through all the levels, Jama Connect will show me the impact that a potential change would have on this, for example, stakeholder requirement. And what we can see here on a direct relationship level, it would impact two validations as well as two system requirements. But on the second degree of separation, we would also impact system architectures, subsystem requirements, and further verifications, as well as already created defects. And Jama Connect supports us to understand to the end degrees of separation, the impact of a change of our initial stakeholder requirement and gives us the opportunity to create informed decisions based on data, which will give us good insights about the potential duration and the cost of a change because it shows us which elements in our product will be affected by this change.

Now if this change then needs to be performed, and this is what I’m going to do now in the next step as a demonstration, we need to have a control mechanism in place that allows us to understand that a change has been made and the downstream objects in our process need to be potentially reviewed. On the right-hand side here in our widget section, the color of the relationships switched from gray to red. This indicates in Jama Connect what we call a suspect link. A suspect link means that the upstream object, in this case, our stakeholder requirement, has been changed, and then the system will notify the engineers that they need to take a look at the downstream elements, in this case, the system requirements and the attached verifications and check if the change of our initial stakeholder requirement impacts the objects one level below. If yes, we can open the objects and perform the change and clear the suspect link.

If the change of the requirement does not have an impact on our downstream objects and the engineer is not required to perform any changes, it can clear the suspect links directly from the interface that we have right here to indicate again that no changes are required, and the widget that we can see here will switch colors directly again. Now we have been focusing quite a lot on the actual doing level right now, but Jama Connect also provides features that give us an insight from a bird’s eye view to really understand the full traceability and decomposition across our project. Now my demo project has 266 items in this project. So a fairly small project overall, but already quite complex to oversee with this amount of data in it. Production projects will have far more data, so the Live Trace Explorer comes in quite handy here especially.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Selg: So what we can do to open this bird’s eye view on our project, we can open the Live Trace Explorer, and now within seconds, Jama Connect will create a real-time overview about the decomposition of our project and will provide a trace score here in the upper right-hand side corner to give me an overview or a health check of the decomposition in my project. Now, what can we see here in this view? First of all, the view shows us the degree of decomposition between the different levels in our process. For example, what we can see here. Out of all my stakeholder requirements that are indicated with this puzzle icon in here, 80% have system requirements derived from them. So this means if you continue with the project, if the current state, 20% of the initial stakeholder requirements are by default, not even considered in the product development, hence, you can never reach the requirements that are there because we don’t even consider them during the development process.

On the next level, we can see the further decomposition, we can see our system requirements that have been decomposed and the next level of decomposition, which, in this case, would be the subsystem requirements. And here, we can see the decomposition rate falls rapidly. Only 12.5% of my system requirements have subsystem requirements attached to them, but the traceability doesn’t stop here due to our bidirectional integration with all the best-in-breed tools and the example that I’ve shown you before with Jira, we can also see the decomposition process from subsystem requirements into user stories and extend the traceability with this view into Jira directly because we have synchronized the information between the two systems. And ultimately, to conclude the left side of the V model, we can also include defects in our breakdown that we can see here.

Now, on the right-hand side, we can see the coverage of tests. We have here, for example, the decomposition of verification. So how many subsystem requirements are covered with verifications, in this case, it’s 72.22%, but only 50% of those verifications are to be assigned to a test plan, which guarantees that they will be tested at a certain point in time. Now, between the different levels, we can see green or red lines, which is Jama Connect indicating to us the validity of the links. So what we can see here between the level is the amount of suspect links that we have between the levels, and this basically shows us how many percent of changes have been incorporated between the levels. And all of this information will go into an internal calculation, which will finally give us a trace score and an overall health check of the project.

Now this is not just a visual representation of your Jama Connect system, but it’s also interactive with a click on, for example, the system requirement decomposition right here, Jama Connect will now open again to trace you with pre-configured filters to show us exactly the decomposition of our initial stakeholder requirements into system requirements. And from here, again, we can start creating missing coverage with new items or we can create missing coverage with already existing items in the system. Again, also if required, cross-project referencing as well. Now with all this traceability information, and the bird’s eye view, and this traceability model as backbone that we have here, Jama Connect also allows us to create so-called dashboards, which we call quality gates that support us in understanding certain key aspects of your project.

Therefore, as a best practice, what we see a lot of our customers do is create a separate dashboard called quality gates where we can create different dashboards that give us certain set of information, for example, regarding rogue development, which means user stories that are created in Jira synchronized to Jama Connect automatically, but are not connected to any subsystem requirements, for example. Or we can also see, for example, in my case, all the approved stakeholder requirements without a test case here on the right-hand side, and all the approved system requirements without a test case here on the left-hand side. And this is quite a good example, what is used heavily with our customers, especially across the consumer electronics industry, because, of course, you don’t want to have approved system requirements that don’t have a test case available.

And especially for a quality engineer, having a real-time overview like this, showing you how many items are in an approved state, but also don’t have a test case available is quite handy to get a good overview about a specific part of your project that you want to have. And with a click on this dashboard, which is updated in real time, we will see all the system requirements in one list that don’t have a test case available and we can now start either now creating work or engineers or we can go start going to the objects themselves and start creating new verification cases or, again, related to existing verification cases, which are somewhere in the system. Now this concludes my live demonstration of Jama Connect regarding identifying gaps and risks in traceability. Thank you very much for attention.

WATCH THE ENTIRE WEBINAR HERE:
Eliminate Gaps and Risks with Proven Traceability Best Practices

In this blog, we recap our recent webinar, “Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively” – Click HERE to watch it in its entirety.

Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively

Engineering organizations face challenges delivering complex products on time, within budget, and with high quality. Teams often work with different tools, creating data silos that slow the digital engineering process. These gaps lead to missed requirements, delays, and defects.

In this webinar, our Jama Software experts Preston Mitchell, Vice President of Solutions & Support; Mario Maldari, Director of Product & Solution Marketing; and Vincent Balgos, Director of Solutions & Consulting, discuss how Jama Connect^®, and our Jama Connect Interchange™ add-on, address these challenges through key use cases.

What you’ll learn:

• Traceable Agile: Integrate systems engineering and software teams using Jama Connect + Jira to drive quality and speed.
• Scalable FMEA Process: Empower reliability and risk management teams with Jama Connect + Excel for efficient FMEA analysis.
• Universal ReqIF Exchange: Seamlessly import, export, and round-trip ReqIF exchanges across requirements tools with Universal ReqIF, enabling teams to co-develop requirements with stakeholders and partners.

The video above is a preview of this webinar – Click HERE to watch it in its entirety!

VIDEO TRANSCRIPT

Preston Mitchell: We are here to talk about how to save precious engineering time, and each of us is going to cover a specific use case that we think will help your teams save a lot of time, utilizing both Jama Connect, as well as Jama Connect Interchange. And when you think about where is most of the time wasted in engineering teams, we typically find it’s something that visually looks like this. It’s siloed teams and tools across the system engineering V model, and we really find that these things are the number one cause of negative product outcomes.

You know them, you’re probably intimately familiar with them. It’s a lack of identification of defects, missed requirements, or lack of coordination. A lot of manual steps to connect things, maybe requirements that live in one tool, and your system testing that lives in a different tool. And a lot of this can be highly manual, which is really a tough thing when you have to satisfy some of the industry regulations that a lot of our customers work with.

As we all know, kind of late detection of issues really leads to a huge cost in order to correct that with a project. You can kind of see in this bar graph here, that I’ve got on the left the different phases, going to the right of a typical product development. So you’re starting in the requirements definition and design, and moving all the way to acceptance testing. Typically, the number of faults or problems are introduced very early in the requirements definition and design phase. But the problem is they aren’t found until later in the project, like during integration or system testing. And even if you get to the acceptance testing level, you can see the exponential increase in cost to fix these expensive errors. These is not Jama Connect’s numbers, these numbers are from sources at The International Council on Systems Engineering (INCOSE) and National Institute of Standards and Technology (NIST). So you can really take away from this is the fewer errors that we introduce early, or the faster or sooner that we identify those issues, the better off we’re going to be and the more engineering time we are going to save.

How do we do this? Well, Jama Software, we are the number one requirements management and Live Traceability™ product in the market. We really bring a lot of resources and technology to bear to help you manage your product development, whether that’s complex and highly scaled types of products. We help you bring all the collaboration and reviews online. And we help you, number one, integrate the different state of the product across the many disparate tools that you might have in your engineering departments, and, specifically, that’s going to allow you to then measure and improve your traceability.

RELATED: Jama Connect Interchange™ for Software and Product Development Teams: Live Traceability Realized

Mitchell: We work with a lot of the key industries that you see here at the bottom, and in particular, like Vincent, you work with the medical devices. I think your use case that you’re going to cover is going to be very built off of that medical device industry. But really, a lot of the use cases we’re going to cover today are applicable to all of these industries.

We are the leader, and we’d like to be bold about it. We are number one according to G2 in terms of requirements management and traceability tools. So we encourage you to check out the different ratings and how we stack up against our competitors.

The ultimate goal that we want to get you to is saving that time. So moving from disparate, siloed teams and tools to an actual integrated system of Live Traceability. We actually have benchmark data from all of our cloud customers, where we can actually show a correlation between the customers that have a greater traceability score, meaning all the expected relationships have been built out. We find that they have 1.8x faster time to defect detection, nearly 2.5x times lower test case failure rates, and then typically a 3.5x higher verification coverage. So it behooves you and your engineering teams to think about how can we actually integrate, and save ourselves time, and that’s just going to create a higher-quality product down the line.

I’d be curious to pause right here. We have a poll. I’d be interested in asking, if you take a step back and think about your R&D teams, all the different tools and teams that you have, what percentage would you say today in your organization is actually fully covered by Live Traceability? 100%, 50%, 0%? I’d be kind of interested in the scale on that. So we should see a poll pop up here, and I’ll give you a couple of seconds to answer that.

Now, we see some answers coming in. Thank you. Yeah, as to be expected, it’s not anywhere near 100%. Most of the companies that we work with are struggling with this, and so this is where we really want to help them out. And how do we do that? Well, our Jama Connect Interchange add-on to Jama Connect is a really powerful tool that we’re going to walk you through today, and it’s going to allow you to automate the connection between your data and process.

So we’re going to cover three use cases. I’m going to talk briefly first about Traceable Agile™, and this is how we integrate systems and software teams, using Jama Connect and a very popular tool that a lot of our software organizations use, which is Atlassian Jira. So we’ll talk about that Traceable Agile use case. Then Vincent is going to cover the Scalable FMEA Process, so how to utilize the power of the functions that are in Excel, and bringing those functions to bear inside of Jama Connect, so that you can do risk management and reliability management, but tied in with your requirements and testing. And then, finally, we’ll end on Mario covering Universal ReqIF Exchange, and this really enables you to co-develop with partners and suppliers across Jama Connect, but also maybe even different requirements management tools. So let’s dive in.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Mitchell: So when you think about Traceable Agile, Agile software, it’s a methodology, as well as a philosophy. It’s been around software teams for a long time, and it works well. It’s been widely adopted, and widely successful. At the same time, a lot of complex products are not made up of solely software. They have to actually be integrated in with the hardware and perhaps other mechanical aspects of these products that you’re building. So there’s a balance, right? There’s a balance of being completely Agile, but also making sure that you follow some process.

And kind of where we find that Agile sometimes can break down when we talk with software engineering leaders. They have these very common questions that they bring up, and it’s what keeps them up at night. How do I know which requirements have been missed? Am I actually covering everything? How do I know that I’m actually testing all of my requirements, and which ones of those have failed? The fourth bullet there, how do I identify rogue developments? It’s like, how do I make sure my teams are not gold-plating the product, and we’re actually meeting the stakeholder or the user needs that we’re trying to deliver to? And then, finally, change. Change is a given in this fast-paced environment, so how do I know when impacts are made? When changes are made in the software or in the hardware, how do I know what those impacts are across?

So the solution to this is Traceable Agile. It’s really no change to how your software teams may work today using Atlassian Jira. Really, what we are adding on is the ability to auto-detect gaps and measure and take action on those. And so I’m going to step into Jama Connect to give you a little bit of a demonstration here.

THIS IS A PREVIEW OF OUR WEBINAR, WATCH IT IN ITS ENTIRETY:
Transform Engineering Processes: Bridge Gaps Between Teams and Tools Effectively

Jama Connect Features in Five: Live Trace Explorer

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.

In this Features in Five video, Francis Trudeau, Product Manager at Jama Software, will introduce viewers to Jama Connect’s Live Trace Explorer, which auto-detects risk by bringing comprehensive and detailed insights into your complex development processes.

Please note that Live Trace Explorer is currently in beta and available for all Jama Connect Cloud customers to try.

VIDEO TRANSCRIPT

Francis Trudeau: Hello and welcome to the segment of Features in Five. My name is Francis Trudeau, and I’m a Product Manager at Jama Software. This video is an overview of Jama Connect’s Live Trace Explorer feature. Note that Live Trace Explorer is currently in beta and available for all Cloud customers to try.

The Live Trace Explorer is like a real-time map of the V-model, helping you check coverage completeness and validity across your project. It actively tracks metrics to spot gaps and risks between engineering teams so you can address issues early. This leads to a smoother development process, higher quality products, and faster time to market. This capability is a significant step in our vision to provide metrics for managing the development process through data.

To enable the Live Trace Explorer, go to the Admin tab, navigate to the Details section, find the Live Trace Explorer line, click Configure, check the box, and save. Once enabled, the feature appears in Admin Project settings and is available for Organization and Project Admins.

RELATED: Best Practices Guide to Requirements & Requirements Management

Trudeau: If permission is granted by their admins, users with a creator license can fully utilize the feature to load and configure existing diagrams. Once enabled, the Live Trace Explorer can be launched by right-clicking a project component or set to create a focused diagram for the selected node or right-clicking the project route to generate a comprehensive diagram showing all components and sets in sequence from top to bottom.

The resulting diagram visually represents the V-model with stakeholder needs, system requirements, designs, and components on the left, and their associated verifications and validations on the right. Each tile represents a component or set connected by trace paths. These paths are gray if there are no relationships between items and adjacent tiles, or they turn green and red to indicate the number of healthy or suspect relationships between them.

On the right side, the Verifications and Validation branch shows the number of Test Cases linked to items within the container on the left, no matter where they appear in the project. At the bottom of each tile, you’ll find a metric representing the ratio of these Test Cases included in a Test Plan. On the requirements side, the top part of each tile displays stats, including the number of items by type and any open conversations.

RELATED: How to Achieve Live Traceability™ with Jira^® for Software Development Teams

Trudeau: In the bottom half, you’ll find coverage metrics, essentially the ratio of active relationships to expected ones as defined by the traceability information model. For example, the model indicates that each high-level requirement should have two relationships downstream. Out of my four high-level requirements, three are covered by validations, giving me 75% coverage. Two are related to mid-level requirements, resulting in a score of 50%. In the Actions menu, you can access configuration settings to customize what’s displayed and measured. You can globally turn off item types, exclude specific relationships from consideration, or you can configure each tile separately.

A common use case consists of configuring your diagram for disabling relationships you are not expected to have at an early stage of your project. Then you may want to disable lower-level requirement items and relationships pointing downstream to them. Once applied, the coverage and total score will update automatically. Make sure to save your diagram once you have configured it to your liking. Live Trace Explorer updates in real-time, so any changes to project data instantly affect the metrics. For example, I can address a gap by clicking on the incomplete coverage. This will open Trace View where I can then establish a relationship to a mid-level requirement. Back in Live Trace Explorer, the metrics and total score summarizing all coverage will be updated after a refresh. You can keep a record and share these metrics by exporting a diagram as a PDF from the Actions menu at the top.

If you’d like to learn more about how Jama Connect can optimize your product, software, and systems development processes, please visit our website at jamasoftware.com.

To view more Jama Connect Features in Five topics, visit:
Jama Connect Features in Five Video Series

In this blog, we recap a section of our eBook, “The Clear Choice: Why Jama Connect Surpasses Codebeamer for Requirements Management and End-to-End Traceability” – Click HERE to read it in its entirety.

The Clear Choice: Why Jama Connect^® Surpasses Codebeamer for Requirements Management and End-to-End Traceability

To adapt to increasing industry challenges and complexities, innovative organizations are now requiring best-in-class software to scale development, reduce risk, save time, and ensure compliance to quality, safety, and security regulations.

As organizations strive to deliver innovative products while navigating regulatory requirements, the tools they use for requirements management and traceability can make or break their success. This eBook is designed to help you understand the critical differences between Jama Connect® and Codebeamer, two leading requirements management solutions, so you can make an informed decision.

The Requirements Sector

The landscape of requirements management has undergone significant transformation. Traditional tools (like IBM® DOORS®) which once dominated the market, are now considered outdated. These legacy systems often lack the flexibility, ease of use, and integration capabilities required by modern teams. As a result, organizations are turning to modern solutions like Jama Connect that are built to meet the needs of today’s dynamic development environments.

Why Jama Connect?

Jama Connect stands out as a leading requirements management solution because it is designed with the user in mind. Its modern, user-friendly interface, combined with powerful features like comprehensive traceability and real-time collaboration, ensures that teams can manage requirements and risks effectively throughout the product, systems, and software lifecycle. Jama Connect also emphasizes customer success, offering expert support and training to help teams maximize their investment. Ease of use, rapid deployment, pre-configured well-documented industry frameworks, and in-house subject matter experts provide the fastest time-to-value/ROI without sacrificing quality or safety.

RELATED: See why users rank Jama Connect as the #1 requirements management tool on the market in the most recent G2 Report

The Clear Advantages of Jama Connect Over Codebeamer

If you’re comparing Jama Connect to Codebeamer, one thing is clear — Jama Connect is the only purpose-built requirements management platform that delivers Live TraceabilityTM which allows engineering and other teams to
quickly and easily access the latest and most complete information for any requirement, no matter the stage of development or tools used. This real-time capability boosts productivity by ensuring teams work with the latest data and reduces risks like delays and defects by finding issues early. In addition, Jama Connect accelerates your product, systems, and software development by managing user needs and product information across the end-to-end development lifecycle.

Only Jama Connect Delivers Live Traceability™ Across Best-of-Breed Tools

Other vendors lock you into inferior platforms. Only Jama Connect seamlessly integrates with your tools of choice across engineering teams.  Only Jama Connect can manage the state of development across all integrated teams and tools. Jama Connect’s unique and industry-specific Traceability Information Models define the relationships and expected behavior across teams and tools.

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Our customers consistently tell us that they chose Jama Connect over Codebeamer for the following reasons:

1. Ease of Use and High Adoptability

Jama Connect’s intuitive design and user-friendly interface make it easy for teams to adopt and use. Unlike Codebeamer, which can be complex and challenging for new users, Jama Connect ensures that teams can start managing requirements effectively with minimal training. Users insist on a requirements management and traceability solution that is easy to use so that both internal and external stakeholders can efficiently access, share, and review information in a single source of truth, increasing and speeding up the adoption across teams for a better ROI.

The ease-of-use is not only imperative for users but also for administrators. Jama Connect offers an intuitive and user-friendly administration interface that enables admins to adapt the tool to their organization’s needs without having to learn overcomplicated configuration settings and concepts.

2. Modern Integration and Collaboration Capabilities

Jama Connect provides comprehensive traceability and impact analysis, enabling teams to manage change effectively and reduce the risk of errors. The platform seamlessly integrates with other best-of-breed tools (including Jira and Azure DevOps) in the development ecosystem, ensuring that teams can work efficiently without having to change their other development tools. In contrast, Codebeamer focuses on working solely with other PTC tools and its own limited application lifecycle management (ALM) capabilities.

Modern product and software development requires optimal real-time collaboration between stakeholders. Jama Connect provides an enhanced collaboration experience with its communication streams and advanced Review Center, enabling both internal and external stakeholders with the capabilities to perform formal and iterative reviews.

3. Intelligent Engineering Management

Jama Connect empowers Intelligent Engineering Management by addressing a critical challenge faced by engineering and product development organizations: the lack of real-time KPIs and metrics during development. This gap often leads to delays, budget overruns, and product defects or recalls. Jama Connect uniquely transforms traceability into a measurable instrument, enabling teams to track real-time metrics and KPIs throughout the product development process. By providing a comprehensive overview of project progress and aligning it with required processes, teams can identify gaps early, mitigate risks, and avoid missed requirements. With its Live Traceability™ and integrations with other best-in-breed engineering tools, Jama Connect ensures that both internal and external data are seamlessly managed, driving informed decision-making and on-time project delivery.

4. Strong Customer Support

We know that our customers need a support team that makes them a priority. That’s why Jama Connect offers unparalleled customer support (including 24/7 support for any production outages), with dedicated customer success teams that work closely with you to ensure you achieve your goals. In contrast, Codebeamer’s support can be limited, making it difficult for your teams to get the help they need when they need it.

5. Scalable and Flexible

Jama Connect is highly adaptable, making it suitable for a wide range of industries and project sizes. Whether your organization is in automotive, aerospace, medical devices, or another industry, Jama Connect can be tailored to meet your specific needs, often getting you up-and-running quickly with custombuilt data frameworks to satisfy your industries regulations and best practices. Additionally, the platform offers flexible deployment options, including cloud and self-hosted, giving you the freedom to choose the best setup for your organization.

6. Fastest Time to Market/ROI

Deploy Jama Connect’s easy-to-use interface in weeks, not months, with easy updates and high performance. Preconfigured frameworks are built-in to satisfy industry regulations and help teams ease the path to compliance, along with in-house industry focused subject-matter experts and exceptional customer support.

7. Lowest Total Cost of Ownership

With simple and straightforward administration and no need for custom scripting or continuous updating, Jama Connect has the lowest total cost of ownership in comparison to Codebeamer. Jama Connect scales easily without big infrastructure investment, and with unlimited no-cost access for extended internal/external stakeholders, all team members can be involved with additional costs.

CLICK HERE TO READ THIS EBOOK IN ITS ENTIRETY:
The Clear Choice: Why Jama Connect Surpasses Codebeamer for Requirements Management and End-to-End Traceability

This post was originally published on January 7, 2022.

Requirements Traceability – How to Go Live

Requirements traceability is required by many industry standards to ensure product quality and safety. The industry standards are based on decades of progress made in systems and quality engineering research with requirements traceability at the core. Benefits from requirements traceability are achieved if and only if traceability is used as a tool during the product development process. These benefits include greatly reduced or eliminated delays, defects, cost overruns, and rework. Here is an overview of the best practice approach to achieve Live Traceability™.

Live Traceability vs. After-the-fact Traceability

Let’s start with some definitions to make sure we are all on the same page. Requirement traceability is defined as tracking the development progress of product requirements from definition and design through development, testing, verification, and validation. There are two forms of requirement traceability: after-the-fact traceability and Live Traceability.

• After-the-fact traceability occurs after the product has been developed and is typically a highly manual effort to try and re-create artifacts to demonstrate traceability that should have occurred during the development process but did not. This effort is undertaken solely for complying with industry standards and satisfying auditor requests for demonstration of process maturity.
• Live Traceability occurs in real time as the product development process progresses to improve overall productivity (by ensuring engineers across disciplines are always working off the most recent and correct versions) and to reduce the risk of negative product outcomes (delays, defects, rework, cost overruns, recalls, etc.) through early detection of issues. The benefits of early detection of issues are significant. Research by INCOSE found that issues not found until verification and validation are 40 to 110 times more costly than if found during design. For this reason, most companies want Live Traceability but are stuck with legacy tools and spreadsheets that do not support it. Since each engineering discipline is allowed to choose its own tooling, the result is a large number of tools with no relationship rules or mechanisms to create Live Traceability across them.

RELATED POST: Requirements Management Guide: Requirements Traceability

So how do you achieve Live Traceability?

Step 1: Define a Traceability Model

Live Traceability requires a model of the key process elements and their relationship rules to monitor during the development process. The systems engineering V Model is a useful framework to start with for data object and relationship definition. Jama Connect® uniquely provides a point and click, configurable, relationship rule capability to enable Live Traceability. Below you see a sample relationship rule diagram from Jama Connect. Relationship rules vary by industry and company-specific requirements. Best practice templates are provided to comply with industry standards and configured to meet client-specific needs. The definition of a traceability model forms the foundation for model-based systems engineering since it defines model elements and their relationship to each other in a consistent manner across the entire system architecture.

Step 2: Setup Continuous Sync for Siloed Tools/Spreadsheets

Once the relationship rules are defined, the next step is to set up continuous sync with best-of-breed tools and spreadsheets used by the various engineering disciplines. The traceability diagram below shows a typical example of best-of-breed tools and where they sync in the Jama Connect relationship model to deliver Live Traceability.

Most companies prioritize the areas of the traceability model that are most prone to lead to costly issues in the absence of a continuous sync. Most commonly, these areas are:

• Software task management – directly linking the decomposition of requirements into user stories enables Live Traceability through the software development process through testing and defect management. The most common best-of-breed tools used are Jira and Azure Dev Ops.
• Test automation – test cases are managed in Jama Connect to align to requirements and ensure traceability across all engineering disciplines with the test automation results sync’d to the traceability model at the verification step. The most common test automation tools are TestRail and qTest.
• Risk analysis (DFMEA/FMEA) – is most often conducted in multiple Microsoft Excel spreadsheets and the assumption has been that Live Traceability was not possible with Excel. Jama Connect is the first requirements management solution to enable Live Traceability with Excel functions and spreadsheets. Risk teams can now work in their preferred spreadsheets AND for the first time achieve live traceability to stay in sync with changes made by any engineering team. Ansys Medini is also a supported integration.
• Model-based systems engineering (MBSE) – the first step in MBSE is to define a relationship model between all product requirements. Once a relationship model is defined, then specifications can be determined through modeling. Jama Connect uniquely provides model-based requirements to sync logically with a SysML modeling tool like Cameo No Magic. Other requirements management tools do not ensure a model-based approach, which most often leads to inconsistent and conflicting fields across teams and projects and provides no coherent relationship model.

Step 3: Monitor for Exceptions

Live Traceability provides the ability, for the first time, to manage by exception the end-to-end product development process across all engineering disciplines. The traceability model defines expected process behavior that can be compared to actual activity to generate exceptions. These exceptions are the early warning indicators of issues that most often lead to delays, cost overruns, rework, defects, and recalls. Below is a view of our Live Trace Explorer that shows you the LIVE state of development for any level of the development project you choose – from the entire cross-discipline effort down to a specific sub-component. Areas of greatest risk appear in red to show where requirement or verification coverage is lacking. Traceability is now a measurement that can be managed and improved with an overall Traceability Score and coverage and verification percentages..

Benefits of Live Traceability

The main benefits of Live Traceability across best-of-breed tools are as follows:

• Reduce the risk of delays, cost overruns, rework, defects, and recalls with early detection of issues through exception management and save 40 to 110 times the cost of issues identified late in the process.
• Comply with industry standards with no after-the-fact manual effort.
• No disruption to engineering teams that continue working in their chosen best-of-breed tools with no need to change tools, fields, values or processes.
• Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments.

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This post was originally published December 18, 2020, and has been recently updated.

Digital Thread Defined

Digital Thread Definition – a data-driven architecture that links together information generated from across the product lifecycle and is envisioned to be the primary or authoritative data and communication platform for a company’s products at any instance of time.

This is the best definition of Digital Thread we are aware of and is from an excellent 2018 paper by Singh and Willcox at MIT entitled Engineering with a Digital Thread. The term Digital Thread was first used in the 2006 with the publication of the Global Horizons report from USAF Global Science and Technology Vision task force. (If you have an earlier reference please share in the comments). In this document, Digital Thread is defined as “the use of digital tools and representations for design, evaluation, and life cycle management.”

As with many business terms, Digital Thread has now become over-used by consultants and software vendors. The definition of it — and how it differs from Digital Twin — have been interspersed with more general concepts of integration, simulation, data, and analytics and has lost the original, more precise meaning.

Digital Thread Components

Let’s break down the definition of Digital Thread into its components to better understand the concept and share the most common approaches we see as companies move to make the Digital Thread a reality. Here is the definition breakdown:

1 – a data-driven architecture

This recognizes that the use of a single common platform is impossible across all engineering disciplines (software, hardware, electrical, systems, risk, QA, etc.). Instead, a data-driven approach is required that determines the key information required from multiple tools. It’s important to remember that data-driven does not mean “gather all your data” but rather that you should be using data to answer questions. In other words, do not fall into the trap of tool focus, but rather focus on the questions and collect data to provide the answer.

2 – that links together information generated from across the product lifecycle

From initial requirement definition through to product release, significant information is generated across multiple tools. The challenge is to identify what information is most relevant and how to best link the information to make it actionable. The most common link we see is the definition of value to be delivered (user and system requirements). The most typical information captured across the product lifecycle are process statuses and exceptions (e.g., requirements that have not been approved, require rework, or are not fully addressed, gaps in testing or risk analyses). By linking these process statuses to requirements and tracking them through the product lifecycle it is possible to reduce the risk of negative product outcomes (e.g., delays, defects, cost overruns).

3 – and is envisioned to be the primary or authoritative data and communication platform

Most companies refer to this as a “system of record” or a “single version of the truth.” A Digital Thread is much more than simply integration or a data lake. By tying the definition of what is to be delivered (requirements) to the most critical downstream process meta-data, a Digital Thread create the ability to understand the state of the product development process, what risks are visible and what corrective actions should be considered. Without a Digital Thread, a company is flying blind in terms of the risks it faces in product development.

4 – or a company’s products at any instance of time

For a Digital Thread to be truly useful it must always reflect the current state of the product development process. The value is in seeing the product development process for the first time across fragmented teams and tools, to be able to identify process exceptions and early indicators of potential downstream risks. A static database of days or weeks old data will not be sufficient for a process that is changing rapidly across multiple, siloed teams.

Why the Digital Thread is So Important

The product development process is often fragmented across siloed teams and tools which leads to significant risk of product delays, defects, cost overruns, failed verification and validation, recalls, etc. End-to-end process visibility is required for better cross-team collaboration and the early detection of anomalies to reduce these risks. To solve for this, organizations often attempt to force everyone to use one common software platform, forgoing their choice best-of-breed tools. This solution is neither practical — nor particularly realistic — since engineers are (and should continue to be) allowed to choose discipline-specific tooling which optimize their activities.

What is required is a loosely coupled approach that ties together the necessary metadata across these disparate tools in a way that connects the desired outcome (user and system requirements) to downstream activities – the Digital Thread. The Digital Thread is the best approach to reduce the risk of negative product outcomes while preserving engineering autonomy and productivity.

Click here to learn how Jama Connect’s Live Traceability™ enables a digital thread.

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