Jama Software Launches Jama Connect® Availability in AWS Marketplace
Jama Software, the industry-leading requirements management and traceability solution provider, announced today that Jama Connect, and its add-ons, Jama Connect Interchange™, and Jama Connect Advisor™ are now available in AWS Marketplace, a digital catalog with thousands of software listings from independent software vendors that make it easy to find, test, buy, and deploy software that runs on Amazon Web Services (AWS).
Jama Connect, designed for teams prioritizing precision and collaboration, streamlines requirements gathering, management, and validation with unmatched efficiency. Now available in AWS Marketplace, customers can easily access Jama Connect, along with Jama Connect Interchange and Jama Connect Advisor—simplifying purchase, management, and integration while enhancing traceability, reducing risks, and accelerating time to market.
“Jama Software’s partnership with AWS highlights our commitment to cloud native and scalable cloud technology. Our collaboration with AWS allows us to work hand in hand with their consultancy services to deliver best of breed cloud native and scalable cloud solutions to our clients. AWS is committed to providing leading edge AI technologies in a ubiquitous manner to their client base. Jama Software leverages this to deliver secure, ethical, and reliable AI technology at the speed of market. Our recent public listing on the AWS marketplace furthers our commitment to this partnership and the success of our clients.” – Jim Davidson, Chief Technology Officer at Jama Software
Jama Connect and its add-ons, Jama Connect Interchange and Jama Connect Advisor are now generally available in AWS Marketplace. For more information on Jama Software and its offerings, please visit https://www.jamasoftware.com/.
Jama Software is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
For more information about Jama Connect services, please visit jamasoftware.com
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.
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.
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.
Jama Connect® Features in Five: Consumer Electronics Development Solution
We value your time, but this Features in Five video goes beyond the five-minute mark to deliver an information-packed session, hosted by Vlad Tanasescu, GM, Industrial & Consumer Electronics, Jama Software.
Developing consumer electronics is complex, but Jama Connect’s new out-of-the-box solution simplifies the process. Discover how Jama Connect helps teams bring products to market faster while ensuring safety, cybersecurity, and seamless collaboration.
With AI-driven automation, real-time gap detection, and integrations with tools like Jira and GitHub, Jama Connect delivers end-to-end traceability and reduces risks. Whether managing product lines or collaborating with subcontractors, this solution is designed to help you work smarter.
VIDEO TRANSCRIPT
Vlad Tanasescu: Hi, this is Vlad from Jama Software, and today I will walk you through a brief live demonstration of our new out-of-the-box consumer electronics development solution. In this video, we will cover how Jama Connect’s intelligent, guided, and measurable product development approach enables us to launch products to market faster, reduce product recalls and re-engineering, how we can leverage Jama Connect’s engineering AI to automate manual day-to-day engineering tasks, how we can natively co-develop with external subcontractors and contract manufacturers in Jama Connect so that we achieve a central source of truth across our entire engineering data, as well as external traceability, and how we can better leverage product cybersecurity, safety, and risk management in the context of our integrated consumer electronics development.
In Jama Connect, we use process models to define end-to-end product development processes, starting from the ideation definition and design of our products, all the way to the manufacturing, software development, and testing. Jama Connect will use these models to guide engineers through the end-to-end development, automatically measure system and process completion, and automatically detect gaps and risks so that organizations know where to take action. Our out-of-the-box consumer electronics solution contains process guidance for the development of integrated consumer electronics products like laptops, phones, computers, or tablets, as well as for the development of consumer electronics app systems like battery systems, displays, or systems on chips, as well as for the development of standalone software consumer applications.
Within Jama Connect, we can measure and manage the end-to-end traceability from the definition of the product from the highest level of the stakeholder need, all the way down to the part and line of code. As part of the development of end-to-end consumer electronics products, practitioners are integrating Jama Connect with multiple other tools for task management, source code management, and product lifecycle management. Jama Connect will exchange data bidirectionally and continuously with these tools, so that in Jama Connect, we can manage the impact of changes across the end-to-end engineering data, and so that in Jama Connect, we can measure completion and detect gaps programmatically across the digital trend.
Tanasescu: For example, here on the left, we can see a project tree. This project tree will enable findability across the entire engineering data and will enable us to display our product structure, including the components, subsystems, and disciplines that are part of those subsystems and components. The project is entirely customizable. For example, within my software component, I can find the software user story that is linked in traceability with the software functional requirement. This software user still exists in Jama Connect and is bidirectionally and continuously synchronized with tools like Jira, Azure DevOps, as well as with manufacturing tools for parts or design tools for models and architectures.
The developers, the mechanical engineers, the designers, they will not make any change to their way of working, and Jama Connect will manage the end-to-end traceability from the highest level of the requirement all the way down to the implementation. Jama Connect will then measure product completion and detect gaps as mentioned before, across the entire product data. Here we can see to what extent the decomposition of our requirements, the testing against the requirements, or the allocations to architectures is complete, and due to the integrations with other software development, task management, or mechanical tools, we can also measure the completion of the implementation and development of our system. This capability enables organizations to know where they have their biggest gaps and product risks so that they know where to take action, and this type of intelligent product measurement hasn’t been possible historically.
For teams developing standalone consumer electronics software applications, Jama Connect can exchange data bidirectionally and continuously with source code management tools like GitHub and GitLab to enable end-to-end life traceability and the understanding of the impact of changes from the requirements all the way to the lines of code.
Product line engineering is a very important part of our consumer electronics framework. In this project, for example, I’m working on the development of a laptop. This laptop has multiple other variants our engineering teams are working on in parallel, and with a couple of clicks, we can get an overview of all of our variants as well as understand the delta between variants with respect to requirements or designs that are only part of one variant or with regards to shared requirements which are part of both variants one and two but slightly different in each products to fulfill the needs of the variants.
Tanasescu: Once we’ve identified the differences, Jama Connect will allow us to synchronize changes between variants or across our entire product library. These capabilities enable product modularization and help reduce the time needed to start the development of new generations. In Jama Connect, we can also maintain libraries of subsystems, systems, or standard requirements. In this example, I’m maintaining multiple battery versions, multiple versions of a subsystem, and whenever appropriate, I can reuse the respective subsystem version in a new development project.
Jama Connect enables multiple product line engineering approaches, which our customers find very useful. The first one is the approach of the library. From the library, we will be reusing content in different product projects. The second one is the approach of a technology platform where we would be setting up a 150% product containing all the data that we could ever use in a variant, and then when a new release starts or when a new generation product starts, we can branch up the necessary content from the technology platform in the variant.
Jama Connect also enables us to work on multiple releases in parallel and bring over changes from one release to another, and the product line engineering approach in Jama Connect is entirely customizable. Another very important component of our consumer electronics solution is native code development. Consumer electronics companies very often work with external subcontractors and contract manufacturers for the development of subsystem technologies. Contract manufacturers can create engineering content natively in the same environment with the OEM so that the OEM can manage end-to-end traceability and detect gaps externally towards the data provided by the subcontractor. Here as an example, we can use Jama Connect to measure the external traceability.
We can see that only 20% of the specifications that we’ve defined internally have been implemented with designs or parts from our external subcontractors. Functional safety as well as cybersecurity are becoming more and more important for consumer electronics companies. The consumer electronics framework contains out-of-the-box safety, cybersecurity, and failure modes and effects analysis data models, which will enable companies to manage risks and the mitigation of those risks as part of one integrated process with the other functional and non-functional elements of the consumer electronics products. The out-of-the-box data models will enable the automatic calculation and classification of the cybersecurity threats, definition and analysis of the safety risks, as well as the failure modes.
Tanasescu: We believe that artificial intelligence is crucial to reducing time to market. In Jama Connect, we are able to automate key day-to-day engineering tasks. For example, I will manually create a requirement that the laptop shall maintain Wi-Fi connectivity, and then, historically, to test against this requirement, engineers would’ve needed to define the test manually. They would’ve described the parameters and the objectives and then defined the steps that the executor would need to go through. Jama Connect’s engineering AI will derive tests automatically and massively reduce the time needed for test generation and validation. The QA engineer can choose to take over one of multiple tests created by AI, and Jama Connect’s AI* will link the test in traceability with the requirements automatically. Jama Connect’s engineering AI can help automate multiple day-to-day engineering tasks like the generation of requirements, the refinement of requirements, or the creation of traceability across the end-to-end process.
Our AI Relationship Discovery** will enable the user to define what relationship suggestions they’d like to receive. For example, I can choose to ask Jama Connect to show me subsystem requirements and system architecture traceability suggestions for my system requirements, and then Jama Connect will query our product library and display multiple objects that we can choose to relate in traceability with our source objects. The user will have the ability to visualize the content of the suggested relationship, and then will be able to intuitively create a traceability link between the source object and the suggested object.
Thank you very much for your time. If you’d like to find out more about our consumer electronics solution, please visit our website. Thank you.
*Test Case Generation available through our add-on product, Jama Connect Advisor™
**Relationship Discovery coming soon as part of Jama Connect Advisor™
A Quality Leader’s Guide: How to Improve Quality Metrics in Medical Device Development
As a Quality leader in the medical device industry, you face constant pressure to not only ensure products are safe and effective, but to make sure your team is staying compliant with all applicable regulations. Passing audits, hitting project deadlines, and achieving first-time regulatory approval are always at the top of your mind. However, these important goals are often undermined by inefficient processes, disjointed systems that hinder collaboration, and teams not following your quality system procedures. The result? Delays, compliance risks, and, at the very worst, potential product issues.
This article provides a practical guide on how to overcome these challenges. We’ll explore how a modern, collaborative solution can help you improve key quality metrics, foster a true culture of quality, and turn compliance from a burden into a competitive advantage.
TL;DR: Discover how to improve your organization’s quality metrics by implementing a single source of truth for requirements, risk, and test management. With Jama Connect®, you can leverage live traceability, out-of-the-box workflows that are compliant to medical device regulations, and powerful reuse capabilities to reduce risk and streamline product development.
The Challenge: Why Traditional Quality Management Falls Short
If your teams are still relying on a mix of documents, spreadsheets, and siloed tools, you’re likely all too familiar with the pain points. Disconnected systems make it very difficult to maintain a clear, up-to-date view of the entire product development lifecycle. This leads to common problems that directly impact your quality metrics:
Inconsistent Processes: When information is scattered, it’s difficult to enforce standardized procedures, leading to deviations and errors.
Lack of Collaboration: Functional groups struggle to work together effectively, causing misalignments between design requirements, risk analysis, and testing.
Inefficient Workflows: Manual tracking and excessive paperwork consume valuable time, slowing down innovation and delaying time-to-market.
Audit & Compliance Risks: Without a clear, traceable line from requirements to verification, proving compliance during an audit becomes a stressful, time-consuming scramble.
The key takeaway: Disjointed systems don’t just create inefficiency; they actively increase risk and make it harder to deliver high-quality, compliant products on schedule.
How to Improve Quality Metrics with a Modern Solution
Transitioning to a modern requirements management platform like Jama Connect provides a structured path to enhancing your quality metrics. It’s not just about new software; it’s about adopting a more integrated and transparent approach to product development.
Step 1: Establish a Single Source of Truth to Foster a Quality Culture
The foundation of any high-performing quality system is a single source of truth. When all functional groups, including engineering, quality, manufacturing, and more, collaborate within one platform, you eliminate confusion and create consistency.
Jama Connect provides this centralized environment where design requirements, risk management, test management, and design reviews are all interconnected. This ensures that everyone is working from the most current and approved information.
Benefit: Teams follow procedures correctly because the system guides them through structured workflows.
Impact on Metrics: Reduces errors, rework, and inconsistencies, allowing you to hit project deadlines.
Step 2: Leverage Live Traceability™ to Reduce Risk and Ensure Completeness
Passing an audit requires demonstrating that every requirement has been addressed from a risk management perspective, verified and/or validated, and properly reviewed., Manually creating and maintaining traceability matrices is prone to error and incredibly time-consuming.
Live Traceability in Jama Connect automates this process. It creates a real-time, dynamic map that links every requirement to its corresponding tests, risks, and design reviews. If a requirement changes, you can instantly see the downstream impact on testing and risk mitigation.
Benefit: You gain complete visibility into your project’s health and can prove compliance with a few clicks.
Impact on Metrics: Drastically reduces audit preparation time and minimizes the risk of findings. It ensures 100% test coverage, directly improving product quality and safety.
Step 3: Streamline Product Development with Out-of-the-Box Compliance
Meeting medical device regulations like ISO 13485, FDA QSR (soon to be QMSR), ISO 14971, and IEC 62304 demands meticulous documentation and adherence to specific processes. Jama Connect helps you streamline this with pre-configured frameworks and workflows designed specifically for medical device compliance.
Instead of building your compliance structure from scratch, you can use these out-of-the-box solutions to get a head start, ensuring your Medical Device File is built correctly from day one. All information can be easily exported into submission-ready documentation for your Quality Management System (QMS).
Benefit: You can reduce paperwork and focus your team’s efforts on innovation rather than administrative tasks.
Impact on Metrics: Accelerates project timelines and increases the likelihood of achieving regulatory approval on the initial submission.
Step 4: Boost Efficiency and Consistency with Reuse
Do your teams develop multiple versions of a similar product or use common components across different devices? Rewriting and re-verifying or re-validating the same requirements and test cases is a major source of inefficiency.
Jama Connect features powerful libraries that allow you to store, manage, and reuse requirements, risk analyses, and test cases across multiple projects. When an item in the library is updated, the changes can be synced to all projects that use it, ensuring consistency.
Benefit: Saves significant time, reduces the risk of inconsistencies, and frees up engineers to focus on innovation.
Impact on Metrics: Improves development efficiency, reduces costs, and ensures a standardized level of quality across your entire product portfolio.
FAQs: Improving Quality Metrics with Jama Connect
Q: How does Jama Connect specifically help with FDA compliance?
A: Jama Connect helps you adhere to FDA design control regulations like 21 CFR 820.30 by enforcing design controls within a structured environment. Its Live Traceability feature is critical for demonstrating the link between design inputs, outputs, verification, and validation. The platform also simplifies the creation and management of your Design History File (DHF), making it audit-ready at all times. For more details, see our guide on FDA Design Controls.
Q: Can we use Jama Connect without completely overhauling our existing toolchain?
A: Absolutely. Jama Connect is designed to integrate with popular engineering tools (e.g., Jira, Azure DevOps, TestRail). It acts as the central hub for requirements and risk management while allowing your teams to continue using the specialized tools they know best, creating a connected, best-of-breed toolchain.
Q: How does this platform help us use quality as a competitive advantage?
A: By streamlining compliance and improving process efficiency, Jama Connect allows you to get safe, effective products to market faster. This speed, combined with reduced development costs and lower compliance risk, gives you a significant edge over competitors who are still bogged down by manual processes.
Take Control of Your Quality Metrics
Stop letting disjointed systems and manual processes slow down your projects. By embracing a modern, integrated approach, you can improve your quality metrics, pass audits with confidence, and empower your teams to deliver innovative medical devices safely and efficiently.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish, McKenzie Jonsson, and Mark Levitt.
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.
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.
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.
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.
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
Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process Customer Story
Biofidelity chooses Jama Connect to enhance the process previously managed manually with Jira and documents.
Biofidelity, headquartered in Cambridge, United Kingdom, provides innovative technologies that unleash the potential of genomics for fast and accurate targeting and monitoring of cancer treatment.
Biofidelity was founded in 2019 with the goal of enabling millions of lives to be transformed through access to vital information needed for accurate targeting and monitoring of treatments for cancer and other illnesses. They develop innovative molecular technologies that remove the noise from genomic data to make analysis simpler, faster, and more adaptable. Healthcare providers, laboratories, patients, and biopharma firms rely on Biofidelity solutions to provide only the information needed to enable swift decision-making and ensure the best possible outcomes.
Biofidelity’s first product, Aspyre® Lung Reagents, is a research use only (RUO) product that enables simple, fast, and reliable detection of established biomarkers in tissue or blood for use in non-small cell lung cancer research. It includes the lab assay and turnkey cloud analysis software designed to be integrated into a customer’s laboratory. The company’s second product, Aspyre® Clinical Test for Lung, is a laboratory-developed test (LDT) that clinicians use to submit tissue or blood specimens to Biofidelity’s CAP-accredited, CLIA-certified lab for analysis with a quick two-day turnaround time from sample to result.
No automated change control and review process for requirements and tests
Documentation preparation took seven to ten days every quarter
Needed to be ready to adapt to changes in regulatory environment
Biofidelity’s competitive edge is in developing products offering simplicity, speed, low failure rates, and sensitivity. As a startup beginning to scale, the company developed their products using a combination of general-purpose platforms, manually tracking requirements and tests, and checking traceability. Managing this information across several documents in separate systems required manual connections, leading to lack of formal traceability between tools. Additionally, while the team could view the history of changes and comments in Jira, there was no established process for reviewing and approving requirements. Significant effort was needed to correctly gather the approved content for release documentation.
For each quarterly product release, the company needed to ensure that all actions were complete and that all information was accurate. However, using Jira made it extremely challenging to consolidate and display all the requirements, test items, and their upstream and downstream relationships. Jira only provided a basic draft table of user needs for verification and left the validation process to be handled manually using a spreadsheet.
The resulting process of generating documents took seven to ten days each quarter. “When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming,” said Adam French, Associate Director of Software & IT, Biofidelity.
Although mandatory FDA oversight of LDTs were originally slated for 2025, Biofidelity demonstrated foresight by recognizing the need to stay ahead of the evolving regulatory landscape. They took proactive steps to improve their product development processes to ensure they could demonstrate compliance.
The need for better processes was driven by the company’s aim to make Aspyre technology accessible to millions of people affected by cancer each year, which requires the ability to adapt to new target markets more
quickly and easily.
When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming. – Adam French, Associate Director of Software & IT at Biofidelity
Automation of requirements and tests change control
Process for reviewing and approving requirements
Faster generation of documentation
The company initially set out to find a test management system. However, they quickly discovered that general-purpose project management software, even with plugins, lacked features for requirements management, collaboration, and traceability. In searching for application lifecycle management systems for medical device development, they found Jama Connect, MatrixALM, and Visure Requirements.
After an evaluation involving the software development team, Jama Connect was chosen for its superior configuration, control, and review of changes, and documentation capabilities. Jama Connect and its Software as a Medical Device (SaMD) framework offered flexibility and a depth of configuration that included templates and pre-configured out-of-the-box item types that closely aligned with the team’s existing Jira issues.
The team valued how Jama Connect offers efficient and reliable control over changes to requirements and tests through traceability. In Jama Connect, impact analysis identifies all upstream and downstream traced items affected by a change. Additionally, suspect links are automatically created after changes are made to designated fields, flagging all downstream requirements that may no longer be accurate, complete, or verified.
“Adding control of changes and relations between all item types was the most important thing for us. You can put relationships between Jira issues, but it doesn’t give you the suspect link notification, review process, or control to check upstream and downstream items after you change a source item,” said Max Artomenko, Software Engineer, Biofidelity.
Aside from the Jama Connect product, there were two other reasons for the choice. The Jama Software team spent a significant amount of time answering and asking questions that went to the heart of what the Biofidelity team needed. In addition, a member of the software development team had previous practical experience of how Jama Connect could be effectively integrated into the software development process.
Reduced documentation preparation time by 33 – 50%
Increased standardization and automation of requirements change control
Development process that’s ready for dynamic regulatory
Ability to expand into risk analysis and additional teams, products, and markets
With Jama Connect, Biofidelity has reduced documentation preparation time for each release from seven to ten days down to two to three days, a 33-50% reduction. More importantly than the time savings, the team remains confident that the information is correct and ready for FDA audits due to the automated traceability, suspect link notifications, and review processes in Jama Connect.
Jama Connect has standardized how and where all the different teams create and store content. That helps ensure the team is alerted when changes are made and manage changes to team makeup. “Most important for the company is to have one source of truth for all user needs relating to software and hardware requirements, even when the teams change,” said Artomenko.
Unlike in the past, the team can do its traceability analysis in Jama Connect at any moment, even during development. This provides greater control of changes that affect the state of software requirements.
The company successfully transitioned their issue types from Jira into Jama Connect item types and experienced improvements in managing them. The plan is to further expand the management of requirements and tests in Jama Connect by incorporating risk management using the FMEA item type, which is readily available in Jama Connect’s SaMD framework.
By shifting risk analysis from Excel to Jama Connect, the team anticipates gaining more efficient control over risks, including immediate ways to demonstrate that all risk items have mitigations that are implemented and tested.
While the software team was the first to use Jama Connect, additional R&D teams are evaluating Jama Connect to potentially manage their user needs, requirements, and tests for other related products. Jama Connect’s support for reuse of existing requirements and tests could translate into faster development of new products and entry into new markets. “One of the key advantages of Jama Connect is that it improves our processes and makes it easier for us to move into new markets and adapt as regulations change,” said French.
“As we move into a regulated space in the future, we expect to be audited more frequently. With the help of Jama Connect’s SaMD framework, we are getting ready to be able to demonstrate that the quality is there every time.” – Adam French, Associate Director of Software & IT at Biofidelity
From AI to Roadmaps: Your Guide to Jama Software’s Upcoming Community Events
Are you ready to connect, learn, and grow with a community of like-minded professionals?
Jama Software Community Events are here to empower our customers with insights, strategies, and tools to maximize your success with Jama Connect®.
Whether you’re tackling challenges in requirements traceability, regulatory compliance, or product and systems development, these events are your gateway to meaningful conversations and actionable solutions.
Please note: These events are for existing customers only. If you are not currently a customer and would like to start a free 30-day trial, click here!
Here’s a sneak peek at the exciting lineup of upcoming events:
1. Explore Customer Success Journeys
Date: August 27, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Discover how tailored support solutions can align with your business goals. Learn about Premium, Strategic, and Essentials Support Plans, and gain practical strategies to enhance efficiency and ROI. Don’t miss this opportunity to elevate your experience with Jama Software.
2. Ask Me Anything (AMA) with our VP of Solutions & Support
Date: September 24, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Get exclusive insights from Jama Software’s VP of Solutions & Support, Preston Mitchell. Learn time-saving strategies, actionable tips, and answers to your burning questions in this interactive session.
Date: October 15, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Join Senior Product Manager Katie Huckett to explore how AI is revolutionizing requirements management and product development. Gain insights into AI-driven tools that enhance clarity, precision, and collaboration.
Date: November 5, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Be the first to learn about Jama Software’s upcoming features and enhancements. This session offers a glimpse into the future of innovation and how it can empower your workflows.
Date: December 3, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Take a look back at the standout features of Jama Connect in 2025. Learn how these innovations have driven efficiency and collaboration and discover how to maximize their impact in your organization.
Date: January 22, 2026 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Kick off 2026 with an interactive Lean Coffee session. Collaborate with experts and peers to tackle challenges in product, systems, and software development.
Date: February 10, 2026 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Engage in a conversation with a leading Jama Software executive. Get firsthand insights into the latest updates, upcoming developments, and strategies to drive impactful results.
Learn from Experts: Gain actionable insights from industry leaders and Jama Software experts.
Collaborate with Peers: Exchange ideas and strategies with power users.
Stay Ahead: Discover the latest innovations and trends shaping the future of product development.
Don’t miss these opportunities to connect, learn, and grow. Reserve your spot today and take the first step toward transforming your potential into action.
Legacy Requirements Tools Present Modern Performance Challenges
When evaluating requirements management platforms, response time emerges as a critical factor that influences user adoption, team efficiency, and project success. Today’s modern engineering projects demand more than legacy solutions can deliver. The speed at which teams can access, modify, and collaborate on requirements directly impacts project timelines, quality outcomes, and overall productivity.
Understanding Response Time in Requirements Management
Response time in requirements management refers to the speed at which a system processes user requests, displays information, and enables collaborative activities. This is comprised of several key indicators:
System Responsiveness: The time required to load requirements, modules, collections, folders, execute searches, and navigate between different sections of the application.
Collaboration Efficiency: How quickly team members can access shared requirements, make modifications, and see updates from stakeholders and team members.
Scalability Under Load: The system’s ability to maintain acceptable performance levels as project complexity increases, and more users access the platform simultaneously. Modern engineering projects often involve thousands of requirements, multiple stakeholders, and tight integrations with various development or System Modeling Tools. Slow response times can create bottlenecks that cascade through the entire development process.
Legacy Architecture and Performance Characteristics
Tools such as IBM® DOORS® have established themselves as a requirements management standard across many industries, particularly in aerospace, automotive, and defense sectors. However, the architecture is a reflection of design decisions made decades ago, which impacts response time characteristics.
Performance Profile
DOORS operates on a client-server architecture that was optimized for local network environments. Users frequently report noticeable delays when:
Loading large requirements modules with complex hierarchies
Performing cross-project searches across multiple projects
Generating reports that span numerous requirement sets
Simple tasks, such as expanding projects and folders
The system’s reliance on a proprietary database and queries for basic operations can result in response times that vary significantly based on database size, network conditions, and concurrent user activity. Unchecked DXL scripts can also be a point of performance degradation and require frequent updating and maintenance.
User Experience Feedback
Teams using DOORS consistently highlight response time as a primary concern. Common feedback includes:
Extended wait times when opening large requirement sets
Delays in search functionality, particularly for complex queries
Slow performance during peak usage periods
Timeout issues when generating comprehensive reports
These performance limitations often force teams to work around the system rather than with it, leading to decreased productivity and compliance issues.
Jama Connect®: Modern Architecture for Enhanced Performance
Jama Connect represents a new generation of requirements management tools, with a modern UI and high performing architecture. This foundation enables significantly improved response times across various operational scenarios.
Architecture Advantages
Jama Connect’s browser-based interface and modern backend infrastructure deliver several performance benefits:
Optimized Data Handling: Jama Connect uses advanced caching mechanisms and efficient data structures to minimize loading times for requirements documents and related artifacts.
Real-Time Collaboration: Built-in mechanisms for live updates and collaborative workflows, such as the Review Center, reduce the latency typically associated with multi-user environments.
Flexible Infrastructure Options: On-Prem and hosted options allow for flexibility when it comes to organizational needs. Jama Connect is certified at SOC 2 as an application and for its hosting environment.
Streamlined Integration: Out-of-the-box integration with systems modeling tools and other best-of-breed applications.
RESTful API: Modern API design enables faster synchronization with external tools and systems.
Performance Metrics and User Feedback
Organizations migrating from legacy tools to Jama Connect report substantial improvements in response time metrics.
Requirement Loading:Users experience faster access to requirements, with loading times reduced by significant margins compared to traditional tools.
Search Performance: Advanced indexing and search algorithms deliver rapid results, even across large requirement sets.
Collaborative Operations: Real-time updates and collaborative features, such as the review center, operate with minimal latency, enabling more efficient team workflows.
Report Generation: Reporting capabilities process complex requirement sets more quickly than traditional approaches.
Comparative Analysis: Response Time Impact on Project Outcomes
Development Velocity
Teams using responsive requirements management tools demonstrate measurable improvements in development velocity. Quick access to requirements information reduces context-switching delays and enables faster decision-making throughout the development process.
Quality Assurance Efficiency
Faster response times in requirements management directly correlate with improved quality assurance processes. Teams can more efficiently trace requirements to test cases, identify coverage gaps, and maintain traceability matrices.
Stakeholder Engagement
Responsive tools encourage broader stakeholder participation in requirements review and approval processes. When accessing and reviewing requirements becomes frictionless, stakeholders are more likely to provide timely feedback and maintain engagement throughout the project lifecycle.
Cost Considerations
While modern tools may require initial investment, the productivity gains from improved response times often justify the cost through:
Reduced time spent waiting for system responses
Improved user adoption and reduced training overhead
Response time and performance represents just one factor in requirements management tool selection, but its impact on daily productivity makes it an essential consideration.
Teams working with complex, rapidly evolving requirements benefit most from platforms that prioritize responsiveness and real-time collaboration. The investment in modern tools often pays dividends through improved team efficiency, faster project delivery, and enhanced stakeholder satisfaction.
Jama Connect Best-in-Class API for Creating Interoperability Across Your Development Toolchain for Live Traceability™
Siloed data creates significant roadblocks for businesses. Isolated information across teams and systems obstructs collaboration and slows critical decision-making. Open APIs provide a solution to this problem by enabling interoperability between compliant software.
Jama Connect features a best-in-class REST API for connecting to any other REST-compliant software or system. Our API is the basis of the many prebuilt integrations available from Jama Software & our partners.
What makes Jama Connect API the best- in-class
Accessible: Anyone with a Creator license can utilize the REST API – at no additional cost and no charges based on number of API calls.
Performant: Each Jama Connect Cloud instance allows up to 36,000 calls per hour/over 26 million calls per month, significantly more than other large SaaS providers.
Reliable: Industry standard best practices, such as API throttling, maintain system stability for consistent and reliable performance with minimal latency.
Comprehensive: We provide documentation accessible through Swagger UI, code snippet examples, and training from Jama Software’s services team who are experts in using the API.
Streamline Integration Processes: Combine Jama Connect API’s simple, flexible, and easy to use framework with the API cookbook, a step-by-step guide with practical, real-world recipes that address common integration needs, offer clear best practices, and answer frequently asked questions.
Boost Data Handling Efficiency: Manage data seamlessly with advanced features like strict pagination and the ‘include’ parameter. These optimizations
ensure your API calls retrieve only what you need, reducing system strain and enhancing performance during data-intensive operations.
Leverage Strict Security and Authentication: Prioritize security with OAuth authentication for Jama Connect Cloud users or Basic Authentication for self-hosted environments. Jama Connect API ensures the integrity and safety of your data during every integration.
Using the Jama Connect API
There are many ways to benefit from the Jama Connect API. Here are several examples:
Reporting: Automate the retrieval of project data for reporting purposes. By making GET requests to the API’s/projects endpoint, users can fetch detailed information about all projects within their Jama Connect instance. This data can then be integrated into business intelligence tools for real-time tracking of project progress, resource allocation, and key milestones.
Data & Trace Synchronization: Automate the synchronization of requirements and their trace relationships between Jama Connect and other REST-based tools for Live TraceabilityTM. This can be particularly useful for organizations that need to ensure alignment between their requirements management system and their development tracking tools. By leveraging the API, users can create scripts to push updated requirements and their traces from Jama Connect into their development platform or pull issue statuses back into Jama Connect.
Test Results Import: Automate the import of test results into Jama Connect. This ensures precise control, real-time updates, and integration with third-party test tools and related workflows for more efficient and reliable verification of new and changes to requirements.
Whether you’re retrieving actionable insights, integrating data across tools, or optimizing test workflows, Jama Connect API empowers your business with flexibility and performance.
