Product Development & Management Archives - Jama Software Jama Connect® #1 in Requirements Management Thu, 30 Oct 2025 00:39:23 +0000 en-US hourly 1 Empowering Complex Development with Responsible AI https://www.jamasoftware.com/blog/empowering-complex-development-with-responsible-ai/ Thu, 30 Oct 2025 10:00:05 +0000 https://www.jamasoftware.com/?p=84657 Collage of various industries such as automotive, medical, and more, to show how many of them rely on responsible AI.

In this blog, we preview a section of our recent Whitepaper – To read it in its entirety, visit “Empowering Complex Development with Responsible AI”

Empowering Complex Development with Responsible AI

Streamlining Efficiency and Compliance with Scalable Solutions

Product and system development is entering a new era, driven by AI innovation. Highly regulated industries like aerospace, automotive, medical devices, and financial services are facing unprecedented challenges such as escalating regulatory scrutiny in some cases, rising product complexity, and the relentless demand to accelerate time-to-market. Navigating these challenges requires a balance of innovation, compliance, and efficiency.

Artificial intelligence is beginning to demonstrate its potential in requirements management by automating manual processes, enhancing decision-making, and streamlining compliance. However, harnessing AI’s full potential requires a commitment to responsible AI practices, ensuring transparency, fairness, and security.

This whitepaper explores how AI is shaping the future of product development, offering insights into its applications, best practices for governance, and the role of Jama Software and AWS in delivering scalable, secure, and responsible AI solutions.


RELATED: Write Better Requirements with Jama Connect Advisor™


Today’s Systems Have Become More Complex

Systems of Systems (SoS)

  • A System of Systems (SoS) is a collection of independent systems, integrated into a larger system that delivers unique capabilities
  • It is difficult to produce accurate predictive models of all emergent behaviors, so global SoS performance is difficult to design
  • Testing and verifying upgrades to a SoS is difficult and expensive (sometimes prohibitively) due to scale, complexity, and constant evolution

AI Applications in Complex Product Development

1. Challenges in Product Development

Complex product development demands businesses to manage an increasing number of variables, such as system interconnectivity, regulatory requirements, and shorter development
cycles. This intensifies the need for precise requirements management tools.

Modern systems, such as self-driving cars, embody system of systems architectures, integrating hardware, software, AI functionality, and cybersecurity. While this creates immense innovation opportunities, the complexity of these systems presents significant challenges:

  • Predicting behaviors accurately
  • Designing test frameworks for integration
  • Scaling verification and validation processes efficiently

These challenges are amplified as the systems grow in complexity and sophistication. Accurately predicting behaviors becomes increasingly critical as interconnected components interact
in unpredictable ways, potentially leading to performance issues, safety concerns, or unintended outcomes. Addressing this requires advanced modeling and simulation techniques capable
of capturing the intricate relationships across subsystems.

Designing effective test frameworks for integration presents its own hurdles. Comprehensive testing must account for the diverse interfaces, software dependencies, and hardware configurations found in modern systems. Without a robust plan, teams risk delays, inefficiencies, and gaps in system validation that can lead to compliance failures or product recalls.

Scaling verification and validation processes to match the demands of high-complexity systems also requires significant innovation. Traditional, manual methods are often unable to keep pace,
resulting in slowed time-to-market and increased resource consumption. Automated solutions offer a scalable pathway, providing traceability, consistency, and efficiency needed to manage
these complex operations effectively.

Ultimately, organizations must balance innovation with rigorous oversight to address these challenges while ensuring safety, reliability, and compliance. Adopting tools designed for enhanced requirements management, streamlined traceability, and automated testing is paramount for achieving these goals in an evolving technological landscape.


RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution


2. AI Solutions to the Challenges

AI-driven solutions are addressing these challenges in profound ways:

Automating Requirements Validation

  • AI uses natural language processing (NLP) to verify that project requirements are complete, precise, and testable
  • By identifying ambiguous requirements early, businesses reduce the risk of failures
  • Automated test case generation cuts time and ensures that all requirements are tested

AI-driven solutions are fundamentally transforming the way businesses address traditional challenges in requirements management and validation. Through the use of natural language processing (NLP), AI automates the validation of project requirements by ensuring they are complete, precise, and testable. This advanced capability allows ambiguities or inconsistencies within requirements to be identified early in the development process. By addressing potential issues proactively, businesses can significantly reduce the risks associated with failures, enhancing overall project efficiency and success.

Ensuring Regulatory Compliance

  • AI tools can help map requirements to stringent regulatory standards in sectors such as aerospace, defense, automotive, and medical devices
  • Automated monitoring ensures continuous compliance throughout the product lifecycle, minimizing risks

Ensuring regulatory compliance is critical for organizations operating in highly regulated industries such as aerospace, defense, and medical devices. AI tools can play a pivotal role in this process by mapping requirements to stringent regulatory standards, ensuring that all necessary conditions are met without manual oversight. These tools offer automated monitoring, which enables continuous compliance throughout the product lifecycle. By reducing the likelihood of human error and streamlining the regulatory process, businesses can minimize risks and maintain adherence to evolving standards, ultimately supporting the success and longevity of their projects.

Accelerating Development Cycles

  • Predictive analytics can enable immediate impact assessments of change requests, minimizing rework and speeding up delivery timelines

Predictive analytics play a crucial role in accelerating development cycles by enabling immediate impact assessments of change requests. This capability minimizes rework, allowing teams to address potential issues swiftly and efficiently. By streamlining workflows and reducing delays, organizations can significantly speed up delivery timelines, ensuring that projects are completed on schedule while maintaining high-quality standards.

Enhancing Collaboration

  • Distributed teams benefit from AI-powered traceability that links requirements, tests, and design components in real time

Efficient collaboration is critical for success, especially for distributed teams. Jama Connect enhances collaboration by providing AI-powered traceability that seamlessly links requirements, tests, and design components in real time. By fostering better communication and streamlining the sharing of critical project information, Jama Connect empowers teams to work more cohesively, reducing misunderstandings and improving overall productivity.


TO READ THIS ENTIRE WHITEPAPER, VISIT: Empowering Complex Development with Responsible AI


]]>
Jama Connect® Named #1 in G2 Fall 2025 Requirements Management Report https://www.jamasoftware.com/blog/jama-connect-named-1-in-g2-fall-2025-requirements-management-report/ Thu, 09 Oct 2025 10:00:29 +0000 https://www.jamasoftware.com/?p=84432 G2 badge showing Jama Connect as Leader, #1 Requirements Management tool in the G2 report.

Jama Connect® Named #1 in G2 Fall 2025 Requirements Management Report

We are thrilled to announce that Jama Connect has once again been recognized as the undisputed #1 leader in G2’s Fall 2025 Grid® Report for Requirements Management Software. This achievement marks our seventh consecutive quarter at the top, a direct result of the trust and feedback from our valued customers.

This continued leadership solidifies our standing ahead of competitors like Polarion, IBM® DOORS®, and Codebeamer. Your reviews and partnership have propelled us to the forefront of the industry, and for that, we are immensely grateful.

Explore the full G2 Fall 2025 Grid Report for Requirements Management Software!

A Testament to Customer Trust and Strong Relationships

G2 reports are a powerful reflection of the user experience, compiling authentic reviews and data to rank software solutions. Being named a leader is a significant honor because it comes directly from the people who use our platform every day to build the next generation of innovative products.

In the Fall 2025 report, Jama Connect’s performance was exceptional, earning accolades that highlight our strong customer partnerships and global reach. We didn’t just maintain our leadership position; we expanded our recognition across multiple new categories.


RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution


Leading the Way: A Look at Our Fall 2025 Badges

Our success this quarter is a testament to the versatility and power of Jama Connect. We are proud to have earned badges across several key areas, demonstrating our strength for businesses of all sizes, worldwide.

Here are the accolades we received in the G2 Fall 2025 report:

  • Overall Leader: For the seventh straight quarter, we are the #1 solution in Requirements Management. We also earned Leader badges for Enterprise, Mid-Market, and Small Business segments.
  • Best Relationship: This new recognition underscores our commitment to partnership. We received this badge for Overall, Enterprise, and Mid-Market, reflecting the high-quality support and collaboration our customers experience.
  • Regional Leader: Our global presence is stronger than ever. We were named a Regional Leader in Asia Pacific, EMEA, and Europe, showing our platform’s effectiveness across international markets.
  • Momentum Leader: This badge recognizes our continued growth and innovation in the market, proving we are consistently evolving to meet modern development challenges.

Voices from Our Community

The praise and constructive feedback from our users on G2 are the driving force behind our innovation. Your insights help us refine our platform and better serve your needs. Here is what some of our users have been saying:

“Jama Connect is a powerful tool for requirements management and offers a wide range of features. Until now, the traceability of requirements was very difficult or even impossible. Jama Connect solves this problem 100%.” – Verified User, Renewables & Environment, Enterprise

“In the past, all requirement-related information was scattered across Jira, Confluence, Word, and Excel, making it difficult to know whether anything was truly up to date. With Jama Connect, we have centralized most of this information into a single, reliable source of truth. The transition is still ongoing, but the shift in mindset is already bringing greater clarity, consistency, and confidence to our work.” – Verified User in Manufacturing, Mid-Market

Driving Modern Requirements Management Forward

This G2 recognition reinforces our mission to help organizations move beyond outdated, document-centric processes. Jama Connect provides a modern platform designed for the complexities of today’s product development landscape.

With Jama Connect, teams can:

  • Improve clarity and collaboration with a single source of truth.
  • Ensure complete traceability across requirements, risks, and tests.
  • Streamline compliance with industry-specific regulations and standards.
  • Accelerate development cycles without compromising quality.

RELATED: The Benefits of Jama Connect: Supercharge Your Systems Development and Engineering Process


A Sincere Thank You to Our Customers

We could not have achieved this milestone without you. Your partnership, feedback, and trust are the cornerstones of our success. These G2 awards are not just for us; they are a shared victory for every team using Jama Connect to solve complex challenges and build amazing products.

Thank you for making us the #1 choice for requirements management. We are committed to continuing this journey of excellence with you.

Learn More

See for yourself how Jama Connect leads the competition. Explore the complete G2 Fall 2025 Grid Report for Requirements Management Software today.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Makenna Imholte.

]]>
How to Master Traceability in Medical Device Development https://www.jamasoftware.com/blog/how-to-master-traceability-in-medical-device-development/ Tue, 07 Oct 2025 10:00:45 +0000 https://www.jamasoftware.com/?p=84407 Laptop and stethoscope sitting on a desk alongside text showing this blog's topic as traceability in the medical device industry.

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.

]]>
Jama Connect® Features in Five: Co-Development with Partners https://www.jamasoftware.com/blog/jama-connect-features-in-five-co-development-with-partners/ Fri, 03 Oct 2025 10:00:54 +0000 https://www.jamasoftware.com/?p=84391 Host's image and name next to a text box reading the topic as being on co-development with partners in Jama Connect.

In this blog, learn about Co-Development with Partners using Jama Connect

Jama Connect® Features in Five: Co-Development with Partners

Discover how Jama Connect empowers seamless co-development with your partners! In this Features in Five session, Mario Maldari, Director of Product and Solution Marketing at Jama Software, demonstrates how Jama Connect’s Review Center enables secure collaboration, granular access control, and iterative feedback cycles. Learn how to streamline cross-company collaboration, maintain a single source of truth, and accelerate your time to market!

VIDEO TRANSCRIPT

Mario Maldari: Hello. My name is Mario Maldari, and I’m the Director of Product and Solution Marketing at Jama Software. Today, we’ll be discussing how Jama Connect allows for co-development with partners while maintaining full control over access.

In a co-development scenario, you can share a Jama Connect project with your partner and utilize our granular permission to control access and information. You can also utilize our comprehensive Review Center and invite partners and stakeholders to participate in requirement reviews. Jama Connect is number one in enabling partner codevelopment. Thousands of engineers are already collaborating across companies today.

Some of the unique Jama Connect features that enable this collaboration are multi-tenant SaaS, no IT involvement required, centralized control of user administration and access rights, a comprehensive and collaborative reuse center, cross-company collaboration, including at mentions, subscribing, and chat streams. The Jama Connect Review Center is number one in partner codevelopment reviews.


RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution


Maldari: Some unique Jama Connect features of our Review Center are iterative review cycles with a dedicated work stream for early-stage peer reviews and final approval reviews, reviewer and approval role control, approval role delegation, related items included in reviews for context and completeness, a reviewer role at no added cost. This includes external partners, stakeholders, allowing for co-development and collaboration. In this video, we will explore how Jama Connect’s Review Center enables co-development with partners.

Arms-length relationships are moving to co-development to speed time to market. Only Jama Connect enables you to include partners in your development process and control their access. Let’s explore how this is achieved in Jama Connect today.

Any artifact or set of artifacts in Jama Connect can be sent to the Review Center. Let’s select a set of stakeholder requirements and create a new review. There are a number of options and configurations that can be selected according to your review process. Internal reviewers can be added as approvers or reviewers. External partners and stakeholders can also be invited to the review simply by adding their email address. They are provided a free license that allows them to participate in the review as codevelopers or partners.


RELATED: The Strategic Transition: From Word and Excel to Modern Requirements Management


Maldari: This allows for all review comments and sign-off from internal and partner teams to be kept in Jama Connect as a single source of truth. In this case, Jim, the project manager, will add Mario as an external stakeholder to participate in the review. Mario will receive an email with instructions and a link inviting him to participate in the review. He can simply click on the link and is able to see all of the requirements that are part of the review and comment, approve, or reject as appropriate. Here is the email that Mario has received from Jim Arlo inviting him to participate in the review. You can click on the link, open the review, and Jama Connect’s simple UI provides an easy way to go through each requirement and collaborate with the internal team. Requirements can be approved or rejected, and new versions of the review created based on updates and subsequent revisions. This can be an iterative and collaborative process between internal teams and external stakeholders.

The end result is quality requirements that are agreed to by both teams. Jama Connect’s Review Center was designed for ease of use and for collaboration with both internal and external teams, allowing for Jama Connect to be the single source of truth for co-development teams. Thank you for watching this Features in Five video on how to use Jama Connect to co-develop with your partners and suppliers. For more information, please reach out to your customer success manager or go to our website at jamasoftware.com


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


]]>
Enhancing Collaboration for Distributed Teams https://www.jamasoftware.com/blog/enhancing-collaboration-for-distributed-teams/ Thu, 02 Oct 2025 10:00:13 +0000 https://www.jamasoftware.com/?p=84380 Man looking at a laptop while having a conference call alongside text that shows the topic of this blog as being enhancing collaboration for distanced teams.
Enhancing Collaboration for Distributed Teams

Delivering high-quality, compliant, and complex products on schedule and on budget is never easy. Whether your hardware and software development teams are distributed globally or nationally, achieving the necessary alignment and coordination of work activities becomes a significant challenge. Engaging your supply chain presents even higher hurdles. This article provides practical insights into fostering effective team collaboration for distributed teams to ensure that your development projects remain on track and your corporate goals are met.

Unlocking Project Success with Structured Collaboration

Why is effective collaboration critical for distributed teams?

When teams operate in silos, the risk of miscommunication, delays, and budget overruns increases exponentially. Navigating different time zones, cultural nuances, and disparate toolsets can lead to information gaps and a lack of a unified project vision. Without a structured approach to collaboration for all internal and external teams, companies struggle to maintain the alignment and coordination necessary to meet aggressive deadlines and deliver products that satisfy customer and industry requirements. This challenge directly impacts your ability to innovate and compete effectively in the market.

How does ineffective collaboration jeopardize project success and regulatory compliance?

When teams aren’t communicating and coordinating, they often miss new or changed requirements or tests. This can lead to expensive rework to address quality or safety issues or project defects during development or product recalls or customer complaints after development. For companies in regulated industries such as medical devices, automotive, or aerospace & defense, these gaps can have severe consequences including failed audits and compliance that can prevent or delay delivery to customers. A lack of a centralized, auditable trail of decisions and reviews involving all necessary stakeholders makes it nearly impossible to prove due diligence which can put the entire development process at risk. Ensuring your teams are on the same page in adhering to standards and best practices is essential for navigating complex regulatory landscapes.


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


What tools centralize communication and streamline critical review cycles?

To overcome these hurdles faced by distributed teams, leading organizations adopt a centralized platform for requirements, risk, and test management that facilitates structured collaboration. Individual productivity tools such as email, documents, and spreadsheets are inadequate for managing the complexity of modern product development by distributed teams because they often result in conversation fragments and version control nightmares. A dedicated platform provides a single source of truth, ensuring every stakeholder contributing to the development process is working from the most current information. This centralization is the first step toward breaking down silos and fostering genuine team collaboration among distributed teams.

How does a platform like Jama Connect® foster seamless cross-function team collaboration?

Jama Connect is designed specifically to address the challenges faced by distributed teams by combining a single source of truth with a structured environment for communication and decision-making. Its intuitive, easy-to-use Review Center functionality allows internal and external stakeholders to provide critical input and feedback directly on requirements and test cases in a clear, contextual, and traceable manner. This eliminates the ambiguity of offline comments and ensures all feedback is captured and addressed systematically. This intuitive process keeps everyone aligned, regardless of their location or time zone.


RELATED: Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense


What are the tangible benefits of Jama Connect’s structured collaboration?

By implementing Jama Connect, you have the solution for completing development on time and on budget. The platform enhances team and work alignment, which reduces costly rework and accelerates development cycles. In addition, you gain greater control and visibility into the development process, allowing you to address issues that the platform automatically identifies for you and ensure compliance with all applicable safety, quality, and other regulations. This leads to faster delivery of high-quality products or systems that meet customer requirements and strengthen your company’s market position.

Take the Next Step

Ready to transform how your distributed teams collaborate and innovate? See how Jama Connect provides a centralized platform that enables your teams to work together to gather input, streamline reviews, ensure compliance, and deliver innovative products on schedule.

Schedule a Jama Connect Demo Today

To learn more, watch a short video about Jama Connect’s powerful collaboration features:

Getting Started with Jama Connect: Collaboration

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mark Levitt and Mario Maldari.

]]>
Mastering Variant Management for Product Line Success https://www.jamasoftware.com/blog/mastering-variant-management-for-product-line-success/ Fri, 26 Sep 2025 10:00:03 +0000 https://www.jamasoftware.com/?p=84349 Robotic equipment in a warehouse.

This Blog Is a Preview of Our Recent Whitepaper, “Mastering Variant Management for Product Line Success” – To Read the Entire Asset, Click HERE

Mastering Variant Management for Product Line Success

The complexity of modern product lines is driving the need for effective variant management.

Explore how organizations can thrive by managing diverse product variants efficiently while addressing market, regulatory, and customer demands. Leveraging expert strategies, including structured feature models, reuse tactics, and traceability approaches, this guide equips businesses with the tools needed to streamline product development processes while maintaining quality and compliance.

Variant management is particularly crucial in industries like automotive, consumer electronics, and software, where organizations must balance innovation with efficiency. By adopting proven methodologies and leveraging advanced tools like Jama Connect®, businesses can reduce complexity, ensure compliance, and optimize product line strategies.

This whitepaper provides actionable insights into how investing in variant management can yield a competitive advantage and fuel growth.

Key Takeaways:

  • Identify and adapt variants to address diverse customer and market needs.
  • Streamline product development with smart reuse and cross-team alignment.
  • Reduce complexity while maintaining traceability across product lines.
  • Ensure compliance in rapidly evolving regulatory environments.
  • Gain visibility to optimize product strategies and decision-making.

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


Discover how your organization can unlock the potential of efficient variant management and take the next step in product line engineering innovation.

Effective product line engineering is a strategic approach that empowers businesses to manage complex product portfolios with efficiency and precision. By addressing diverse market demands, streamlining development processes, and ensuring compliance amidst evolving regulations, organizations can achieve a competitive edge in today’s dynamic industries.

Central to this approach is the concept of variant management, which simplifies complexity, strengthens collaboration, and drives innovation across teams.

The ability to reuse and align product components across teams is not just a matter of efficiency but a necessity in maintaining agility. With better visibility into product strategies and calculated decision-making, businesses are better positioned to adapt and thrive.

By leveraging robust variant management practices, teams can maximize reuse, reduce inefficiencies, and maintain a competitive edge.

With expertise in variant management, product managers and engineers can effectively tackle pressing organizational challenges, enabling their businesses to stay ahead in the market while scaling operations intelligently.

“Product companies utilizing single-system engineering and management approaches may end up with highly complex and low-quality products, low productivity, high employee turnover, and less than expected customer satisfaction.” – ISO/IEC 26550:2015(E) (SSPL) Software and systems engineering — Reference model for product line engineering and management

List of the benefits of PLE and Variant Management.

Why Businesses Need Effective Variant Management

Variant management is a critical component of modern business strategy, especially in industries characterized by high variability and complexity. A well-structured approach to managing product variants can enable companies to respond efficiently to dynamic market demands, adhere to increasing regulatory constraints, and meet evolving customer needs.

The pressures businesses face today are numerous and interconnected. For instance, market demands have grown rapidly, with customers expecting highly customized products and shortened lead times. Without effective variant management, businesses risk falling behind competitors who are better equipped to deliver tailored solutions. Additionally, regulatory constraints, particularly in industries such as automotive and healthcare, require meticulous compliance that can only be achieved through streamlined product configurations and robust tracking mechanisms. Businesses must also grapple with changing customer preferences, which necessitate agility in the design and delivery of new product variants.

Data supports the notion that inefficient variant management can have severe financial and operational repercussions. Companies struggling with outdated or manual processes often see rising costs, delays in production, and errors in product delivery. For example, a case study in the automotive sector highlighted how poor variant management led to production bottlenecks, ultimately delaying vehicle deliveries and incurring significant reputational damage. Similarly, in the semiconductor industry, the inability to manage design variants efficiently increased engineering costs and time to market, diminishing competitive advantage.

Conversely, businesses adopting advanced techniques and tools for variant management have demonstrated remarkable improvements. The automotive industry provides a notable example, where companies leveraging advanced configuration systems reduced production errors and improved time-to-market metrics. Semiconductor companies employing automated design variation tools saw reduced development cycles, enabling them to remain leaders in innovation while containing costs.

Effective variant management is not just an operational necessity — it is an enabler of long-term strategic success. By addressing the challenges of market demands, regulatory compliance, and customer expectations with data-driven strategies, companies can secure both competitive and financial advantages in even the most complex industries.

Studies have shown that organizations leveraging robust variant management strategies can experience up to a 20% reduction in production time and a 15% decrease in overall costs, according to recent industry analyses. Furthermore, a survey conducted by Deloitte highlighted that 85% of companies implementing advanced variant management systems reported improved customer satisfaction due to better customization options and faster delivery times. These metrics underscore the tangible benefits of adopting data-driven approaches to variant management, emphasizing the critical role they play in enhancing operational efficiency and fostering innovation.

Effectively managing product variants requires overcoming significant challenges, especially in areas such as traceability, operational inefficiencies, and collaboration across teams. These obstacles can hinder innovation, escalate costs, and delay critical processes, ultimately impacting market competitiveness.


RELATED: The Strategic Transition: From Word and Excel to Modern Requirements Management


Mitigating Traceability and Quality Assurance Issues

Navigating the complexities of tracking changes across multiple product variants is critical. Without a centralized system, it becomes nearly impossible to maintain visibility and ensure quality across diverse versions. Version control gaps can lead to costly errors, regulatory challenges, or even safety risks, particularly in highly regulated industries. A robust variant management solution provides the tools to document and trace changes efficiently, ensuring comprehensive oversight for all stakeholders involved.

Streamlining Inefficient Processes

Inefficient processes not only increase time-to-market but also inflate development costs and risk inconsistencies that impact customer satisfaction. Leveraging a purpose-built solution ensures that all teams have access to aligned workflows and automated updates, creating a streamlined development cycle. Effective management reduces redundancies, accelerates decision-making, and enables a focus on delivering high-quality products faster.

Bridging Alignment Gaps Across Teams

Communication breakdowns often arise when managing multiple product lines across geographically dispersed or cross-functional teams. Maintaining synchronized collaboration ensures everyone operates from a single source of truth, reducing misunderstandings and keeping deliverables on track. Solutions that foster seamless collaboration help establish a unified framework, bridging the gap between engineering, design, and compliance teams.

“Before using Jama Connect, it was a constant struggle to manage the sheer complexity of variant tracking and communication between teams. Adopting a tailored solution transformed our workflow, helping us cut time-to-market by almost 30% while maintaining traceability across all versions.” – Jama Connect Customer

Overcoming these challenges with modern variant management tools empowers organizations to innovate efficiently while keeping costs and risks in check. Such systems provide the structure needed to scale operations without compromising quality or alignment, ensuring long-term success in an increasingly competitive marketplace.


Ready to Learn The Solution for Best Practices for Variant Management? Download the Entire Whitepaper:
Mastering Variant Management for Product Line Success


]]>
[Webinar Recap] Making Sense of ASQMS: A New Standard for Automotive Software Quality https://www.jamasoftware.com/blog/webinar-recap-making-sense-of-asqms-a-new-standard-for-automotive-software-quality/ Wed, 24 Sep 2025 10:00:11 +0000 https://www.jamasoftware.com/?p=84309 Two photos of the speakers for this event on the topic of ASQMS and Automotive Compliance.

In this blog, we recap a preview of our recent webinar. Click HERE to watch it in its entirety.

Making Sense of ASQMS: A New Standard for Automotive Software Quality

The Next Automotive Software Standard Is Here. Are You Ready for ASQMS?

The shift toward software-defined, new energy, and intelligent vehicles is transforming the automotive industry. As vehicles become more reliant on complex software to power advanced features, autonomy, and connectivity, the need for robust quality management has never been greater. To meet this challenge, China’s CACPQSP introduced the Automotive Software Quality Management System (ASQMS).

In this blog, we recap a preview of our recent webinar in which hosts Sathihya Ramamoorthy (Jama Software) and Ronald Melster (Melster Consulting GmbH) discuss how ASQMS fits into the standards landscape and why it matters for your teams.

What You’ll Learn:

  • An overview of ASQMS, who published it, and why it matters
  • Key differences between ASQMS, ASPICE, and IATF, including new lifecycle requirements
  • Why ASQMS complements, rather than replaces, ASPICE
  • Practical tips for risk-based software classification and lifecycle coverage
  • Actionable next steps to strengthen software quality and efficiency

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

VIDEO TRANSCRIPT PREVIEW

Ronald Melster: Thank you very much for the warm introduction and thank you very much also for inviting me to today’s webinar. I am excited to be here with all of you and to share with you the information about this new standard ASQMS. So let’s get started and explore what the standard means for the automotive world and how we can best adapt to it. For those of you who don’t know me yet, my name is Ronald Melster. In the automotive world, I’m simply known as Ron. As one of Europe’s most experienced Automotive SPICE principal assessors, I have spent nearly three decades helping organizations transform their development processes. Since 2005, I’ve been guiding teams not just to achieve higher capability levels, but to truly understand the why behind effective processes. My journey began in the 1990s when I studied computer science in Berlin and Edinburgh, but I quickly discovered my passion for software engineering and processes. What started as a love for coding evolved into a mission to help teams balance structure with pragmatism.

Over the years, I have had the privilege of working with industry leaders like Bosch, Audi, Porsche, and Here Technologies. One of my biggest achievements was leading a Bosch development division with 7,000 engineers worldwide to capability level 3, proving that even larger teams can embrace systematic improvements. But here’s what I’ve learned. Assessments are not just about ratings. They’re about empowering people, building confidence, and creating sustainable change. Whether it’s functional safety according to ISO 26262, cybersecurity, or process improvement initiatives, I’m here as your mentor, coach, and sparring partner. Maybe you have heard the rumors about this new China standard and you want to learn more about it. You have come to the right place. Let’s start with the name of ASQMS, Automotive Software Quality Management System. That’s the full name of the standard, and yes, it’s a Chinese standard.

We will take that apart piece by piece in this webinar. So the first question is which body exactly published this ASQMS standard? And the answer is the Chinese Association of Consumer Products Quality and Safety Promotion, short CACPQSP. Say this three times. This body is dedicated to consumer rights and their safety and regulates consumer products, including cars. To promote this, they created the ASQMS standard and demand that each OEM selling cars in China needs to be certified according to the standard. So naturally, it applies to Chinese OEMs selling in China, and it also applies to European OEMs wanting to sell cars in China as well. And there’s more. The OEMs are required to request the certificate from their suppliers as well, so it also applies to any supplier tier two or tier one if they want to be part of the supply chain for cars sold in China.

Let’s have a look at why they created the standard and why we need another standard if we have Automotive SPICE or ASPICE. The reason for that is the dependency on software in the car. The complexity is growing rapidly. The number of technical and organizational interfaces gets bigger every day, and the cars increasingly rely on data coming from the outside. Let me share an observation with companies trying to reach capability level 2, according to Automotive SPICE. At the beginning of the project, the capability level is at a stable level 0. Then it takes one, or two, or even three years to get to level 1 and then to level 2. Then the project delivers the result and is finished. And the next project start again at level 0. I call this cycle the chainsaw or zigzag, up and down and up and down. It’s a huge waste of time and effort, and might have led to the ASPICE frustration, which we observed in networks like LinkedIn.


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


Melster: Why is that? Because the knowledge is not captured after the project in the company, nor is it standardized or rolled out. Only few companies have managed to establish a stable level 3 with a standard process according to ASPICE. Why can a project not start in a systematic way, aka level 2 or level 3, from the start of the project? This will also reduce the technical debt, which is built up every time a project starts from level 0. There are some of the reasons why this new standard was developed. We need a strong focus on software development. We need to include the software outside the vehicle, and we need to focus on the organization to provide standard process which is applied in each and every project in a similar way. And I might add that we need to take care of the software long after the initial development phase. In a world with rising cybersecurity issues, the software must be maintained and updated if new threats become known. Therefore, ASQMS includes the entire life cycle, including the termination of the software with a systematic deletion of all personal data.

Let’s talk about what’s inside the standard ASQMS and how it’s structured. The standard contains three kinds of requirements, which must be implemented by a company which wants to be certified according to ASQMS. The first one are basic practices, not base practices, but basic practices. They’re mandatory for all automotive development. The second kind of practices are advanced practices. They must be implemented by products which are safety or cybersecurity relevant. And the third type of requirements are recommended practices. They should be implemented by all software projects. The ASQMS standard follows a risk-based approach, which means that not all requirements, which are defined by the standard need to be implemented in each development program. For that, a classification is introduced, the two classes or types of software.

Type II is a software that carries a risk related to safety or cybersecurity, and type I is the rest of the software, which is not related to safety or cybersecurity. For type II software, the cybersecurity or safety-related, the basic practices are mandatory, and the advanced practices are mandatory. The recommended practices are recommended. For type I software, which are not as critical, only the basic practices are mandatory, and advanced and recommended practices are optional. ASQMS clusters the processes into three groups: operational processes, supporting processes, and system management processes. The operational processes include project management and the entire V-model with requirements engineering, architectural design, detailed design and implementation, unit verification, integration, and verification testing.

Apart from these well-known engineering processes, the following processes are defined as part of the operational processes: supplier management, software release, software deployment, software maintenance, user information management, and software termination. So there’s some overlap and some new processes. The supporting processes include some which we already know from Automotive SPICE like configuration management, problem resolution management, change request management, and of course, quality assurance. They even have the same process names. The basic practices may differ in some aspects. And some new supporting processes are introduced like documentation management, equipment and facilities, knowledge management, revenue management, and externally supplied products and services, which includes the management of free and open-source software.


RELATED: Jama Connect® for Automotive


Melster: With the system management processes, something completely new is introduced. They’re not to be confused with the system development processes, which we know from ASPICE. System here refers to the quality management system in the name of ASQMS. So it’s similar to ISO 9001, or ITF 16949, or an information security management system, which gets certified by TSACS. These processes include the scope and the context of the organization, the quality management system fundamentals like quality policies and roles, personnel management, performance evaluation, and the continuous improvement process. In this next section, I will highlight some of the key changes when we compare Automotive SPICE with ASQMS. The first one is the software, which is in the scope of the standard ASQMS. The requirements are not only mandatory for in-vehicle software, which many of us have known for a long time, but also for software outside the vehicle is in scope.

This includes any software in the cloud providing data to the vehicle or to an entire fleet. It furthermore includes any system along the roads, so-called roadside systems. Again, exchanging information with the car or even controlling the behavior of the vehicle. And it applies to the software tool chains which are used for software development and maintenance. The next important change is the lifecycle. Automotive SPICE development projects typically stop with the release of the finished software, whatever this means. The maintenance phase is usually left out or ignored, and really no one thinks about the termination of the software in an ASPICE project. This will change with ASQMS. The entire lifecycle of the software must be covered. This only starts with the initial development phase and must be continued with the ongoing maintenance of the software until the termination of the software. You might want to know, what is the termination more than switching off the software? Well, many software instances store data, oftentimes personal data, and this information must be securely deleted as part of the termination.

Many companies claim that they are ASPICE level 2 certified. However, this is not true. There is no such certification. What they have reached in most cases is a level 2 in one project at a certain time. So this does not apply to any other project in the same company without performing additional assessments, nor is the claim true in the future or after the assessment for the same project. So here’s the last key change I will talk about. ASPICE assessments are statements about projects at a certain point in time. This statement cannot be carried over to any other project in the company, nor is it valid in the future. ASQMS, on the other hand, focuses on the organization. This means that the organization must establish processes to fulfill the requirements and maintain them in each and every development project. This also includes internal auditing activities to make sure that all projects follow the defined rules and methods. And as I’ve mentioned earlier, it also includes processes to provide competence staff to the project. Only then will the company get the ASQMS certificate, which is published by an external auditor.

So what have we learned today about how ASPICE and ASQMS can work together? First, ASPICE integration. ASQMS will not replace Automotive SPICE. Instead, ASPICE can be used to show the conformance with the overall standard processes. And if you are already using ASPICE at the project level, these methods can be scaled to the entire organization using the approach of ASQMS. Second, both standards have shared goals. They’re built on the same fundamental principles, traceability, clear structure, and well-defined roles. Whether you’re working on a senior development project or managing quality across multiple teams, these core elements remain the same. And finally, ASQMS is extending the scope. Here’s where ASQMS goes beyond traditional ASPICE scopes. It adds organizational elements like leadership development, culture building, and personnel focus. The reality, ASPICE and ASQMS work as a partner, not competitors. Automotive SPICE gives you project-level excellence while ASQMS builds the organizational capability to sustain that excellence across all your software activities. Together, they create a comprehensive quality approach that works at every level.


This Has Been A Preview of Our Webinar, To Watch the Full Webinar, Visit:
Making Sense of ASQMS: A New Standard for Automotive Software Quality


]]>
Data-Driven Reports Show Jama Connect® Outperforms Key Competitors Polarion and Codebeamer https://www.jamasoftware.com/blog/data-driven-reports-show-jama-connect-outperforms-key-competitors-polarion-and-codebeamer/ Fri, 12 Sep 2025 10:00:05 +0000 https://www.jamasoftware.com/?p=84096 Person sitting at a desk with a laptop open to the SoftwareReviews report.

Data-Driven Reports Show Jama Connect® Outperforms Key Competitors Polarion and Codebeamer

Finding the right requirements management software can make or break your product development process. With countless options flooding the market, how do you separate genuine value from marketing hype? Two new comprehensive reports from SoftwareReviews provide the answer with data-driven insights that cut through the noise.

These head-to-head comparisons pit Jama Connect against two major competitors: Polarion ALM and Codebeamer. Based on verified user feedback from the July 2025 Data Quadrant Award, the results paint a clear picture of industry leadership that might surprise you.

The Data Behind the Decisions

SoftwareReviews, a division of Info-Tech Research Group with over two decades of research experience, doesn’t rely on vendor claims or marketing materials. Their methodology digs deep into real user experiences, collecting over 130 data points on each product across the entire software lifecycle.

Every review undergoes rigorous quality assurance to ensure authenticity. Only verified users with legitimate credentials can participate, creating a trustworthy foundation for decision-making. This approach reveals insights you won’t find in traditional product comparisons or vendor demonstrations.

The reports examine both quantitative metrics and qualitative feedback, measuring everything from technical capabilities to emotional satisfaction. This comprehensive view helps you understand not just what the software can do, but how it feels to work with it daily.


RELATED: The Benefits of Jama Connect: Supercharge Your Systems Development and Engineering Process


Five Critical Areas That Define Success

Strategy and Innovation

Your requirements management platform needs to evolve with your business. The reports evaluate how well each vendor demonstrates forward-thinking innovation and supports customer growth initiatives. Jama Connect shows particularly strong performance in helping customers innovate and continually improving their platform.

Users consistently report that Jama Connect inspires innovation within their organizations, while competitors struggle to maintain the same level of strategic vision. This matters because today’s software purchase becomes tomorrow’s competitive advantage — or disadvantage.

Service Experience

Technical support can make or break your software experience. When critical projects hang in the balance, you need responsive, effective support that treats your business with respect. The data reveals significant differences in how vendors handle customer relationships.

Jama Connect users report notably higher satisfaction with service quality, describing interactions as respectful, efficient, and time-saving. This translates to faster problem resolution and less downtime for your team.

Product Experience

Features matter, but user experience determines adoption success. The reports examine how well each platform enhances performance, maintains reliability, and protects organizational data. These factors directly impact productivity and user satisfaction across your entire team.

The comparison reveals substantial gaps in product experience metrics, with Jama Connect consistently outperforming competitors in reliability and productivity enhancement. Users describe the platform as performance-enhancing rather than burdensome.

Negotiation and Contract

Software procurement involves complex negotiations that set the tone for your entire vendor relationship. The reports evaluate how vendors handle contract discussions, pricing transparency, and initial relationship building.

Data shows marked differences in negotiation approaches, with some vendors prioritizing client interests while others focus primarily on their own objectives. These patterns often predict long-term satisfaction levels.

Conflict Resolution

Disputes and disagreements inevitably arise during software relationships. How vendors handle these situations reveals their true character and commitment to customer success. The reports examine trustworthiness, fairness, and integrity under pressure.

Results show significant variation in conflict resolution approaches, with some vendors maintaining professionalism while others become adversarial. Understanding these tendencies helps you choose partners who will support your success even when challenges arise.


RELATED: IBM Customers Choose Jama Connect the Most


Beyond Surface-Level Comparisons

Traditional software evaluations focus on feature checklists and pricing tables. These reports dig deeper into the human elements that determine real-world success. They examine emotional footprints, measuring user sentiment across multiple dimensions of vendor relationships.

The Net Emotional Footprint Score captures user feelings about vendor trustworthiness, respect, and fairness. These emotional responses predict long-term satisfaction better than technical specifications alone. The data reveals substantial differences between vendors in building positive user relationships.

Users don’t just evaluate software — they evaluate the entire experience of working with a vendor. This includes everything from initial sales interactions through ongoing support relationships. The reports capture these nuanced experiences that traditional product reviews miss.


RELATED: Companies Choose Jama Connect Over Codebeamer


Comprehensive Feature Analysis

The reports examine 11 core product features specific to requirements management, including:

  • Agile Work Management: Sprint planning, backlog management, and artifact hierarchy
  • ALM Integration: Cross-phase artifact integration through APIs and internal systems
  • Analytics and Reporting: Real-time dashboards and data extraction capabilities
  • Artifact Management: Creation, reuse, and audit capabilities for project artifacts
  • Collaboration: Real-time work sharing and communication features

Each feature receives detailed evaluation based on actual user experiences rather than vendor specifications. This reveals gaps between promised functionality and delivered value.

The analysis shows consistent patterns of performance across feature sets, helping you identify vendors who excel broadly rather than in isolated areas. This comprehensive view prevents costly surprises after implementation.

Vendor Capability Deep Dive

Beyond product features, the reports evaluate 11 essential vendor capabilities that determine long-term partnership success:

  • Business Value Creation: Ability to generate organizational value
  • Vendor Support: Quality and timeliness of customer assistance
  • Usability and Intuitiveness: Learning curves and adoption barriers
  • Implementation Ease: Deployment complexity and timeline predictability
  • Data Integration: Compatibility with existing systems

These capabilities often matter more than individual features because they affect every aspect of your software experience. Vendor support quality, for instance, impacts how quickly you resolve issues and implement new functionality.

The data reveals significant performance variations across these capabilities, with some vendors excelling consistently while others show uneven performance. This information helps you avoid vendors who might excel in sales presentations but struggle with execution.


RELATED: Discover Why Polarion Users Are Switching to Jama Connect


Making Data-Driven Decisions

Requirements management software represents a significant investment in both financial and organizational terms. The wrong choice creates cascading problems that affect project timelines, team productivity, and business outcomes. These reports provide the evidence needed to make confident decisions.

User feedback reveals real-world performance under actual business conditions. You’ll learn how software performs during high-stress periods, how vendors respond to urgent support requests, and how well platforms scale with growing requirements.

The comparative format lets you evaluate trade-offs between different approaches. Some vendors prioritize feature breadth while others focus on user experience. Understanding these strategic differences helps you align vendor strengths with your organizational priorities.

Your Next Steps

Don’t let requirements management software decisions rest on vendor demonstrations and marketing materials alone. These comprehensive reports provide verified user insights that reveal true performance patterns and vendor capabilities.

The data shows clear performance leaders across multiple evaluation categories, but your specific needs might prioritize different factors. Download both reports to understand the complete competitive landscape and identify the best fit for your organization.

Each report includes detailed breakdowns of user satisfaction metrics, feature comparisons, and vendor capability assessments. You’ll gain access to insights from verified users who’ve implemented these platforms in real business environments.

Requirements management affects every aspect of product development. Choose your platform based on comprehensive data rather than surface-level impressions. These reports provide the evidence you need to make decisions that drive long-term success.

Download the comprehensive head-to-head comparison reports against Polarion, Codebeamer, and IBM® DOORS Next® today and discover why users consistently choose Jama Connect for their requirements management needs.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mario Maldari, Makenna Imholte, McKenzie Jonsson, and Decoteau Wilkerson.

]]>
Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect® https://www.jamasoftware.com/blog/streamline-medical-device-postmarket-surveillance-by-taking-a-full-lifecycle-approach-with-jama-connect/ Tue, 02 Sep 2025 10:00:43 +0000 https://www.jamasoftware.com/?p=83988 Person holding up a phone against a laptop, against text showing medical device postmarket surveillance.

In this blog, we recap a section our recent datasheet, “Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect” – Click HERE to read it in its entirety.

Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect

Postmarket surveillance (PMS) is an expected regulatory activity that plays a vital role in ensuring the safety and effectiveness of medical devices after they reach the market. The key to an effective PMS program is to ensure that the requirements and risks identified early in the development process are continually updated throughout the product’s lifecycle. Maintaining “living” design documentation allows companies to better identify, analyze, and respond to potential safety issues. As new information about the product comes from user feedback, clinical studies, or complaint reports, teams can review and update all product information in Jama Connect, allowing them to conduct better investigations and continually enhance the product as a benefit to patients.

Jama Connect for Medical Devices streamlines and simplifies the PMS process by providing a single source of truth for a product’s entire lifecycle. Whether it is managing requirements, performing risk analyses, or conducting effective change management, companies can meet all regulatory requirements and provide patients with safer and more effective devices.


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


KEY BENEFITS:

  • Improve Postmarket Surveillance by Using the Same Platform During Development and Post Launch: Jama Connect is a full lifecycle platform that allows companies to manage requirements, testing, and risk analyses both during development and after launch, ensuring all PMS activities are managed efficiently and reliably.
  • Enhance Risk Management Through Structured Collaboration: Build or easily migrate risk management items into Jama Connect so that internal and field-based teams can work together to collect and analyze product safety information and implement better corrective and preventive actions faster.
  • Modernize Change Management by Maintaining a Living Design Documentation File: Create a real-time view of all product design and risk information in Jama Connect and utilize automated workflows to conduct change management activities.

Seamlessly Transition from Development to Surveillance

Jama Connect’s ability to create Live Traceability™ across your development tool chain ensures that every step, from ideation to postmarket adjustments, is documented and traceable.

Organizations that use Jama Connect for managing requirements, tests, and risk during development and postmarket surveillance can conduct investigations and implement product changes with greater speed and confidence to minimize the impact on patients and the company.

Finding success in Jama Connect is not just limited to those starting a new project from scratch. A company with many existing projects can transfer all requirements and risk information using migration solutions and services provided by Jama Software. This will create a strong foundation that helps the organization enhance postmarket surveillance activities and improve future development.


DOWNLOAD THE ENTIRE DATASHEET TO LEARN MORE:
Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect


]]>
Extending End-to-End Traceability into the Semiconductor Design Cycle https://www.jamasoftware.com/blog/extending-end-to-end-traceability-into-the-semiconductor-design-cycle/ Tue, 26 Aug 2025 10:00:16 +0000 https://www.jamasoftware.com/?p=83890 Close up on a semi conductor chip alongside text showing this topic as end-to-end traceabability for the semiconductor design cycle.

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


]]>