Purpose-built support for automotive systems and components, ensuring compliance with ISO 26262, ISO 21434, ASPICE, and other critical industry standards.
Centralized platform for managing requirements, tests, risks, and traceability with end-to-end visibility.
Tools for improving productivity, reducing defects, and ensuring seamless traceability to meet safety and security standards.
With Jama Connect, automotive teams can reduce rework, prevent recalls, and bring products to market faster while staying audit-ready.
Plus, leverage pre-configured frameworks and work with Jama Connect consultants to customize the solution to your exact business needs.
Grant Rhodes: Hello, and welcome to the Jama Connect Features in Five series. My name is Grant Rhodes, and I’m a Senior Solutions Consultant here at Jama Software.
Today, we’ll be walking through the automotive solution. Jama Software provides robust tools and solutions to help automotive developers streamline compliance with ISO 26262, ISO 21434, ASPICE, and other critical industry standards.
Centralized Management with Jama Connect
Through Jama Connect, teams can manage requirements, tests, risks, and traceability in a centralized platform, ensuring end-to-end visibility across the development cycle.
This level of traceability is crucial for demonstrating adherence to safety and security standards. It enables significant productivity and quality improvements, dramatically reduces the risk of product delays, cost overruns, defects, rework, and recalls, and ultimately results in faster time to market.
The Jama Connect automotive solution is a complete set of frameworks, example projects, and procedural documentation intended to accelerate the implementation of Jama Connect for organizations developing automotive systems and components. The foundation of our automotive solution is Jama Connect, our industry-leading, best-in-breed requirements management solution.
Purpose-Built for Automotive Development
Purpose-built to track the requirements of complex systems and reduce risk and inefficiencies of document-based legacy systems, the automotive solution allows teams to start working in Jama Connect with zero setup and configuration time. Alternatively, teams can work with a Jama Connect consultant to customize the solution to meet their company’s exact business needs.
Rhodes: The automotive solution frameworks come in the form of projects in Jama Connect. These include definitions of item types and relationships as well as example project hierarchies that are aligned to key industry regulations. Here, I have the base automotive framework project open.
This image represents the traceability information model applied within this project and visualizes the allowable data types and relationship rules. Requirements are covered by lower-level requirements or design elements and are related to test case items to prove compliance. In addition to the item types and relationships, each framework also contains a project structure designed to highlight important sets of data.
These models and hierarchies have been designed using input from industry best practices and are usable out of the box. However, Jama Connect is configurable and can be customized to meet any needs specific to your organization or product development cycle.
Sample Projects for Hands-On Experience
In the project tree, we can see that in addition to the framework projects, the solution also delivers sample projects.
These utilize a framework but are populated with sample data. In these projects, teams can get hands-on experience with the defined item types and relationships. For example, opening the automotive safety and security sample set project, we can see an example of a hazard analysis and risk assessment (HARA).
Rhodes: The automotive solution also includes many export templates and reports for generating HTML, PDF, Word, and Excel outputs from the system.
Some reports are generic and included in all Jama Connect instances. Others are targeted for automotive customers, providing content and formatting specific to industry needs. For example, the HARA and TARA reports give the ability to export safety and security items from a project. Since the sample set project is populated with data, we can use it to better understand the outputs that these reports deliver.
Conclusion
Thank you for watching this Features in Five session on the automotive solution for Jama Connect. Existing customers, if you want to learn more, please reach out to your Customer Success Manager or Consultant. New customers, if you are not yet a client, please visit our website at JamaSoftware.com to learn more about the platform and how we can help you optimize your development process.
Build Better AECO Projects: Overcome Misalignment, Rework, and Scope Creep
Architecture, Engineering, Construction, and Operations (AECO) projects are large, complex, and increasingly regulated. Yet many teams still manage owner requirements, design intent, and change decisions using disconnected documents, spreadsheets, and siloed repositories.
The result is misalignment between stakeholders, costly rework, scope creep, and limited traceability from early owner requirements through design, construction, and handover.
Join Dale Brown, Director, Infrastructure at NSI Advisory Services, and Jama Software experts, as they discuss the real-world challenges of requirements management in AECO projects.
What You’ll Learn:
Why document- and spreadsheet-based approaches fall short on complex AECO projects
How poor requirements visibility leads to misalignment, rework, and scope creep
Practical ways to manage change while keeping stakeholders aligned
How to maintain traceability from early owner requirements through design, construction, and handover
What modern AECO teams need to support audits, compliance, and delivery confidence
THE VIDEO BELOW IS A PREVIEW – WATCH THE ENTIRE PRESENTATION HERE
TRANSCRIPT PREVIEW
Requirements Under Construction: Bringing Control and Traceability to AECO Projects
Dale Brown: Thanks for inviting me to the conversation. Yeah, a lot of those folks probably really are doing systems thinking, or as we call it, systems engineering, but it doesn’t have to be engineering. It’s just using that system’s view of the world. So I’ll just try to explain it in a fair way, using lay terms as opposed to a lot of tech speak. I mean, we live in a very complex world in our daily lives. We’re surrounded by a complicated environment. Our cars, our phones, our homes, our offices, schools, trains, and planes. And we ourselves are pretty complex creatures.
And we’re part of a community, usually which is part of a town or a city, which is part of a state, which is part of a region, part of a country, and part of the planet. So that’s kind of the way all these parts, you can see how they aggregate. And that’s really what systems thinking is. It’s thinking about where I fit into a bigger picture, potentially, a bigger environment. So in the case of an infrastructure project, you would know that there are local codes of practice, state and national codes, and maybe even international. So where do I fit into all that?
And especially for the architects who are looking at the bigger picture to see how their design, what is the look and feel of what they’re trying to accomplish, both internally to say it’s a structure, or externally, if it’s a cool new stadium or anything really, does it fit? Maybe it’s not intended to fit, maybe it’s intended to stand out. So all of those external things affect their system thinking, and that’s it in lay terms. Hopefully that makes sense.
Joe Gould: Yeah, it definitely does. It’s a great perspective, Dale, great way of thinking about it. So thank you for that. So let me ask you then, where do you already see systems engineering principles showing up in AEC, even if we don’t call them that?
Brown: Yeah. And I mean, the terminology is such a big thing, Joe. But yeah, I see it all the time because you’ll get civil engineers who know they have to think outside of their particular part. And if we think that, again, using the word systems in defining what it is, it’s a collection of parts, or the more formal definition is a group of elements that form a system. But if you think of it just in parts, what’s their part in it? What is it that they’re designing? And so they’re already understanding, okay, they probably, if it’s the foundation person, they probably have to talk to the soils engineer.
And at some point, the civil and electrical guys have to talk, or the conduits are going to be put in the wrong place in the concrete. And that sort of thing, they’re already thinking about the system, even if it’s just the aesthetics, the look and feel. So they’re doing this, and they have been doing it for, well, I guess 6 or 7,000 years. So it’s not new. But I think what’s new and what’s kind of crept up is a new terminology related to aerospace, and actually, software has been the big push.
Gould: Sure. No, that’s great, Dale. I’m hearing systems engineering more and more inside AEC firms. We have some large construction companies that we work with that are using systems engineering practices, for lack of a better term. Let me ask you then, so what are the most critical issues facing AEC companies today from, say, a delivery and risk perspective?
Brown: Yeah. What I’ve seen on a lot of big multi-billion dollar projects is that at some point, you have to provide a defensible audit trail of all the decisions, not all, but the critical decisions you’ve made, and especially if it’s a change order or something like that, why did you make that change? How is it documented? And where can I see that evolution of things in the design and then ultimately in the actual build? And if you can’t show that to either state safety oversight or a local building inspector, or the client, you’ll probably not get permission to occupy and use the facility for revenue service, which just means that from that point forward, all you’re doing is damage control.
You’re burning cash, you’re sadly probably also burning reputation, both of the owner, especially if it’s public money, and the state authority, whoever’s involved in it. So that’s the big risk: you build this thing and you either can’t use it because you’ve made some sort of an error partway through, or you’re not allowed to use it, which is almost kind of worse because you’re there, but you can’t provide that assurance.
Gould: Right. Yeah. I mean, you definitely answered my question. It’s like, what happens when you can’t answer those questions? And it sounds like it’s pure damage control, is what it is. And I think you nailed it, Dale. Can you talk about the financial and organizational impact of this lack of, and I’ll use the word traceability, and if you could just quickly define what traceability might mean, I think I know what it means, but I’ll ask the expert. What impact does that have financially and organizationally?
Brown: Yeah. So again, traceability is one of those terms that have become quite popular throughout aerospace and software design and development. And really, what it means is a defensible audit trail showing that this part must do the following things in the following ways in a certain environment. So you have to be able to show the relationship between all of those, which we call requirements. They can just be needs, but whatever terminology you want to use, you have to show that it’s linked and it has to be a repeatable thing. It has to be something that you can consistently show the linkage to, and that’s how we refer to traceability.
Also, if you’re doing tests, if you’ve built it or you’ve partially built it, and you need to show evidence that you’ve actually designed and built it to whatever requirements or codes of practice that are needed, then you need to show, again, that defensible linkage, and it has to be done consistently. So that to me is kind of a long definition of traceability, but hopefully it works.
Gould: Yeah, no, that definitely works. The impact of change, obviously, in the world of AEC, it’s not if it’s going to change, it’s when it’s going to change.
Brown: Yeah, yeah.
Gould: And having that, again, for lack of a better term, traceability or defensible audit trail, whatever we want to call it, is just absolutely huge. And really when we look at project management tools, I feel like they’re great for managing a project, use many of them across the board, but when you need to get granular on something and we need to understand impacts and decisions and have that audit trail like you spoke of, I mean, that’s just gold and financially not having it can just have a huge impact on the profit margin of that project. So thanks for that, Dale. So have we seen, I mean, I can speak to this, but have we seen real projects go sideways because of a lack of traceability?
Brown: Yes. Often, the old adage is that systems fail at interfaces, and if you don’t understand where something is connecting to something else, basically an interface, then that’s probably going to fail. And it can be as simple as the control rack doesn’t fit in the room, or the air conditioning that was designed for the room, the person designing the HVAC unit didn’t realize what the heat load was from that rack of electronics. And so there’s an example. Another more common one that I see sadly in almost every project is that the conduits were buried in the concrete in the wrong location, or they were the wrong size, or an assumption was made that you could mix the high voltage or even medium voltage with low-level signals. So those are examples of what happens. And some of those can get pretty expensive because the concrete’s still green, and already you’re breaking out the jackhammers.
Gould: Yeah. I mean, that’s such a huge impact on projects, and so thank you for that. Let me ask you this. If systems engineering or traceability is so valuable, then why has AEC been so slow to adopt these practices? I don’t understand.
Brown: Yeah, it’s been a frustration and a passion of mine for a couple of decades now, almost, seems like 15 years anyway. And what’s happened is I think a lot of it is the words matter discussion we had earlier, where if you present it the wrong way and try to deploy it as if building a new train station or a new skyscraper or anything is the same as writing software. So if you use all the code terminology and try to ram that down the throats of people that have got, as I said earlier, thousands, if not hundreds of years of expertise backing up their education and they’re used to doing things a certain way and having a certain terminology guide them, they may not refer to requirements, or maybe in their mind, requirements means contract requirements only, and it’s not the same as a formal technical requirement, those sorts of misunderstandings in words.
But when you start throwing so much new terminology, and you force them, and you say, “You must do things this way. You have to get all the system requirements first.” And the civil guy, or maybe the architect on the project, is saying, “What do you mean? What are these words?” And they may or may not be familiar with it, depending on their age and their experience. And if you’re not communicating to them that you’re really just looking for what the user needs, what are the local codes of practice, what’s the basis of design? What are going to be the exceptions to the code, and maybe those are the ones that we have to really focus on because the rest of the stuff is already covered through normal building practices.
So now we’re kind of getting into a point of a side discussion, but a really important one on efficiency. So what’s happened is the industry has seen a lot of bureaucracy foisted on them through some words in a contract document that says, “You shall incorporate ISO 15288 systems engineering.” And they’re not familiar with it or the terms in a lot of cases. That’s changing slowly, but it’s also, you can’t apply it directly out of the software world into the AEC world. It just doesn’t make sense. You have to tailor it, you have to make it make sense.
So if you end up with making them do work twice, which is what happens in a lot of cases where they’ve already done a basis of design document, but now they have to deal with requirements in a separate requirements document or tool that was very expensive and they don’t understand how to use the tool and it’s been prescribed to them in the contract, sometimes they even put the tool in the contract and it gets very frustrating. So there’s been a bad history of this over the past few 15 years anyway, and we’re trying to turn a corner on that and really address maybe it’s just the exceptions to code that we really need to show extremely good traceability, extremely good audit trail evidence.
We don’t have to show every single nuance of every single design because it’s just normal practice. It’s going to be checked through and accepted through local building codes anyway. So let’s not do it two or three times. And I think that’s the distaste, and it’s created the resistance, in my opinion.
2026 Predictions for Nuclear Energy: Innovation, Safety, and the Path to a Sustainable Future
The nuclear energy industry stands at a pivotal moment where innovation and tradition intersect to tackle the world’s most urgent challenges: decarbonization, energy security, and sustainability. From the emergence of small modular reactors (SMRs) and advanced reactor designs to the adoption of AI, automation, and digital engineering, the sector is embracing transformative technologies that are set to redefine how nuclear power is designed, operated, and perceived.
Key trends shaping the nuclear landscape include the transition from conceptual innovation to deployable solutions, the role of digitalization in enhancing safety and efficiency, and the evolution of regulatory frameworks to support next-generation technologies. Additionally, cybersecurity, workforce development, and global collaboration are becoming essential pillars of the industry’s future, ensuring that growth and innovation remain firmly grounded in the safety-first principles that define nuclear energy.
In this final blog of the 2026 prediction series, we bring these insights to life with perspectives from Jama Software’s industry expert, Patrick Garman, Solutions Manager for Energy, Industrial, and Consumer Electronics sectors. Patrick shares a forward-looking vision for 2026 and beyond, exploring the deployment of SMRs and advanced fuels, the integration of predictive analytics and real-time monitoring, and the innovations, strategies, and cultural shifts that will shape the nuclear industry’s role in a clean energy future.
Curious to read leading thought leaders’ predictions for their industries in 2026 and beyond? Dive into each blog below:
Q: What next-generation technologies (e.g., small modular reactors, advanced reactor designs, digital control systems) will have the most significant impact on the nuclear industry in the next five years? How can organizations prepare to adopt and regulate these innovations safely?
Patrick Garman: Over the next five years, the nuclear industry is likely to be shaped by a practical shift from conceptual innovation to deployable technology. Small modular reactors (SMRs) and microreactors are expected to lead this transition, moving beyond pilot projects toward early commercial use thanks to their modular construction, smaller footprints, and ability to serve diverse applications, from grid support to industrial process heat and remote operations. In parallel, advanced non-light-water reactors, such as high-temperature gas, molten salt, and fast reactors, are gaining traction as long-term solutions for high-efficiency power generation and emerging use cases like hydrogen production and industrial decarbonization. These reactor designs are closely linked to advanced fuels, including HALEU and TRISO, making fuel availability, qualification, and supply chain readiness a central factor in how quickly projects can move forward. At the same time, the industry is embracing digital instrumentation and control, automation, and data-driven operations to improve performance, reliability, and safety while also introducing new considerations around software assurance and cybersecurity. Underpinning all of this is a growing reliance on factory-based manufacturing, modularization, and robotic inspection, which promise to reduce construction risk and improve quality, provided these methods can be consistently qualified and aligned with regulatory expectations.
Safety and Risk Management
Q: Safety has always been central to the nuclear industry. How can digitalization, real-time monitoring, and predictive analytics further strengthen plant safety and reliability? What cultural or procedural shifts are needed to sustain a modern safety-first approach?
Garman: Digitalization is giving the nuclear industry new ways to reinforce its longstanding safety-first foundation by improving visibility, consistency, and foresight across plant operations. Real-time monitoring and predictive analytics allow operators to detect early signs of equipment degradation, performance drift, or abnormal conditions well before they escalate into safety or reliability concerns, while modern digital control and decision-support systems help reduce human-factor risk by delivering clearer, more contextual information during both normal and off-normal operations. To fully realize these benefits, organizations must evolve their safety culture and procedures to treat software, data, and analytics as safety-relevant assets governed with the same rigor as physical systems, while strengthening the human-automation partnership through training, validation, and clear operational boundaries. A modern safety-first approach, therefore, extends beyond traditional engineering excellence to include disciplined digital governance, cybersecurity resilience, and continuous learning, ensuring that advanced technologies enhance the conservative decision-making that defines nuclear safety.
Digital Modernization
Q: How do you see digital engineering and integrated data environments improving plant lifecycle management, from design through decommissioning? What challenges exist in migrating from legacy systems to modern digital platforms?
Garman:Digital engineering and integrated data environments are changing how nuclear plants are managed across their entire lifecycle, helping teams maintain clarity and control from early design decisions all the way through operations and eventual decommissioning. By creating a connected digital thread that links requirements, design models, safety analyses, construction records, and operational data, organizations can avoid the information loss that often happens at handoffs between phases or teams. This continuity makes it easier to manage design changes, maintain configuration control, respond to regulatory questions with confidence, and use operational insight to plan maintenance, life extensions, or decommissioning activities more effectively.
The biggest challenge is not the technology itself, but the transition. Many nuclear organizations are working with decades of legacy systems, documents, and institutional knowledge that were never designed to work together. Migrating to modern digital platforms requires careful, phased approaches that preserve trust in the data, maintain regulatory confidence, and respect the realities of long-lived assets that cannot pause operations for wholesale transformation. Success depends on strong data governance, disciplined change management, and a clear understanding that digital modernization is a long-term capability investment.
Regulatory and Compliance Evolution
Q: As global interest in nuclear energy grows, particularly across the EU, how can the industry ensure regulatory frameworks keep pace with innovation? What best practices can help organizations streamline compliance without compromising safety?
Garman: As interest in nuclear energy accelerates, the challenge is ensuring regulatory frameworks evolve alongside innovation without undermining the industry’s uncompromising safety standards. New reactor designs, fuels, and digital technologies don’t fit neatly into licensing models that were built around large, conventional plants, which means regulators and industry alike must continue shifting toward risk-informed, technology-inclusive approaches. This evolution works best when developers engage regulators early and often, clearly articulate their safety case, and align on expectations for evidence, review milestones, and decision points before designs are finalized.
Best-in-class organizations are streamlining compliance by treating it as an integrated engineering discipline rather than a late-stage documentation exercise. That means embedding regulatory requirements directly into design and development workflows, maintaining clear traceability from safety objectives to implementation and verification, and reusing proven arguments, data, and analyses wherever possible. At the same time, harmonization efforts across jurisdictions, transparent regulatory collaboration, and disciplined change control help reduce duplication without sacrificing diligence. The result is a more predictable path to licensing that supports innovation while preserving the conservative, safety-first principles that underpin public trust in nuclear energy.
Q: As nuclear facilities adopt more connected technologies, how can organizations guard against cyber threats while maintaining system integrity and safety? What proactive measures should become industry standard?
Garman: As nuclear facilities adopt more connected and digital technologies, cybersecurity is becoming inseparable from plant safety and reliability. Guarding against cyber threats starts with treating operational technology as safety-relevant infrastructure that is designed from the outset to limit the impact of any compromise through strong segmentation, controlled data flows, and isolation of critical functions. Leading organizations focus less on individual tools and more on disciplined system architecture, configuration control, and integrity protection, ensuring that digital systems behave predictably even under adverse conditions.
The industry is converging on practices such as secure-by-design engineering, rigorous access and change management, continuous monitoring tailored to OT environments, and well-rehearsed incident response that includes operations and engineering, not just IT. Ultimately, sustaining system integrity in a more connected nuclear plant depends on a cultural shift that recognizes cybersecurity as an extension of nuclear safety itself, governed with the same conservative mindset and operational rigor that public trust in the industry depends on.
AI and Automation
Q: What role will AI and automation play in improving design and manufacturing of nuclear reactors and efficiency, safety inspections, and predictive maintenance across nuclear facilities? What safeguards are needed to ensure responsible, transparent use?
Garman: AI and automation are set to play an increasingly practical role in the nuclear industry, particularly in areas where consistency, pattern recognition, and early detection matter most. In design and manufacturing, AI-assisted analysis can help engineers explore design alternatives, identify potential safety or manufacturability issues earlier, and improve quality through automated inspection, welding verification, and non-destructive evaluation. Across operating plants, automation and advanced analytics support more efficient inspections and predictive maintenance by detecting subtle equipment degradation, prioritizing risk-significant issues, and reducing unnecessary exposure of personnel to hazardous environments. Used appropriately, these technologies strengthen safety and reliability by helping teams act earlier and with better information.
Responsible AI deployment in the nuclear industry means applying the same conservative, evidence-based mindset that governs other safety-relevant systems. That means clearly defining where AI provides decision support versus where humans retain authority, validating models against real-world data, monitoring performance and drift over time, and maintaining full transparency into how recommendations are generated. Strong data governance, configuration control, and cybersecurity protections are essential, as is the ability to audit and explain outcomes to regulators and operators alike. When paired with clear safeguards and human oversight, AI and automation can become trusted tools that enhance the nuclear industry’s long-standing commitment to safety and public confidence.
Sustainability and Public Perception
Q: How can the nuclear industry strengthen public trust while positioning itself as a key player in the clean energy transition? What strategies are most effective for communicating safety, sustainability, and innovation to the public?
Garman: Strengthening public trust is ultimately about consistency between what the nuclear industry says, what it does, and what people experience over time. As nuclear positions itself as a critical enabler of a reliable, low-carbon energy system, the industry has an opportunity to connect its long-standing safety culture with today’s clean energy priorities, emphasizing not just carbon-free electricity, but resilience, energy security, and long-term environmental stewardship. Trust grows when organizations are transparent about both benefits and risks, communicate clearly how safety is engineered and governed, and demonstrate that lessons learned are actively shaping modern designs and operations.
The most effective communication strategies focus on clarity, credibility, and relevance to everyday concerns. That means moving beyond technical jargon to explain safety, waste management, and sustainability in plain language, using real data and independent validation rather than promises. Engaging early and continuously with communities, regulators, and policymakers helps demystify nuclear technology and humanize the people behind it. By pairing transparent communication with visible innovation, strong regulatory oversight, and measurable climate impact, the nuclear industry can reinforce public confidence while positioning itself as a trustworthy and essential contributor to the clean energy transition.
Q: With a generational shift in the workforce, how can the nuclear industry retain institutional knowledge while equipping new engineers with the digital and safety-focused skills needed for the next era of nuclear operations?
Garman: The challenge is to preserve institutional knowledge while preparing a new generation of engineers to operate in a far more digital, data-driven environment. Leading organizations are addressing this by deliberately capturing design intent, operating experience, and lessons learned in structured, accessible formats while pairing this with training that blends systems thinking, digital engineering tools, and a strong grounding in nuclear safety culture. Mentorship, cross-generational teams, and scenario-based training help bridge experience with innovation, reinforcing conservative decision-making even as new technologies are adopted. Ultimately, success depends on treating knowledge management and workforce development as long-term strategic investments, ensuring that the next generation has access not just to new tools, but have the mindset and discipline that have define safe nuclear operations.
Global Collaboration and Standardization
Q: How can international collaboration and harmonized safety standards support the safe expansion of nuclear energy, particularly as more nations revisit nuclear as part of their net-zero strategies?
Garman: Collaboration and harmonized safety standards are essential to the safe and timely expansion of nuclear energy as more countries turn to nuclear power to meet net-zero goals. Shared regulatory principles, common safety objectives, and mutual recognition of technical assessments help reduce duplication, improve consistency, and raise the global safety baseline – especially as new reactor technologies are deployed across multiple jurisdictions.
Collaboration among regulators, operators, and international bodies also accelerates the exchange of operating experience and lessons learned, allowing emerging nuclear programs to benefit from decades of global expertise. When paired with strong national oversight, this alignment supports innovation without compromising rigor, enabling countries to expand nuclear capacity with confidence while reinforcing public trust in nuclear safety worldwide.
Future Outlook
Q: What trends—technological, regulatory, or geopolitical—will most influence the global nuclear industry over the next decade? How can companies balance growth, innovation, and safety as nuclear energy plays a larger role in global sustainability goals?
Garman: Over the next decade, the global nuclear industry will be shaped by a convergence of technological innovation, evolving regulatory approaches, and shifting geopolitical priorities tied to energy security and decarbonization. Technologically, the progression of small modular and advanced reactors, digital engineering, and data-driven operations will expand where and how nuclear can be deployed, while fuel supply chains and cybersecurity will remain strategic constraints. Regulators are increasingly adapting frameworks to accommodate new technologies through risk-informed, technology-inclusive approaches, even as geopolitical dynamics, such as supply chain resilience, international collaboration, and regional energy independence, reshape investment and deployment decisions. To balance growth, innovation, and safety, companies will need to embed safety and compliance into their innovation processes from the outset, engage regulators and stakeholders early, and maintain disciplined governance over digital and organizational change. Those that succeed will be the ones that treat safety not as a brake on progress, but as the foundation that allows nuclear energy to scale credibly and sustainably in support of global climate and energy goals.
Requirements Elicitation: A Step-by-Step Approach to Defining the Right Requirements
The success of any new product or project hinges on a simple, yet challenging task: collecting requirements. When done well in a carefully controlled process that lives up to the more aptly named eliciting requirements, it leads to a product or project that meets everyone’s expectations. When done poorly in a haphazard manner, it results in costly rework, missed deadlines, and a final delivery that fails to satisfy anyone.
The process of gathering input from a diverse group of stakeholders—each with their own priorities and perspectives—poses multiple risks. Time and costs can quickly spiral, and the danger of missing a critical requirement is ever-present. This article explores the basics and benefits of following a systematic process for requirements elicitation.
The High Cost of Unstructured Requirements Collection
Product and project leads are under pressure to get requirements complete before anything else begins. Without a systematic process designed to ensure intended outcomes, project or program success is exposed to these significant risks:
Wasted Time and Resources: Ad-hoc soliciting, eliciting, tracking, and organizing requirements in documents and spreadsheets is incredibly time-consuming and prone to error. This inefficiency directly translates to higher project costs and slower time-to-market.
The Risk of Missing Requirements: A disorganized process makes it easy for critical requirements to fall through the cracks. Discovering these gaps late in the development cycle leads to expensive changes and frustrating delays.
Incomplete Stakeholder Input: Failing to identify and engage all relevant stakeholders—from internal teams like Sales and Product Management to external partners like customers and partners—can result in a product that is misaligned with market needs or technical constraints.
The key takeaway: An ad-hoc approach to collecting requirements is not just inefficient; it’s a direct threat to your project’s success.
How to Systematically Elicit Requirements: A 5-Step Process
To mitigate these risks, adopt a structured approach. These steps will help you gather, organize, and track requirements with greater clarity and efficiency.
Step 1: Define the Project or Project Scope and Objectives
Before you elicit a single requirement, ensure everyone has a shared understanding of the goals. What problem are you trying to solve? Who are the users, and what are their priorities? What does success look like? What industry or corporate standards will require documentation to demonstrate compliance?
A clear project charter or vision document is essential for keeping all subsequent requirements aligned with the core objectives. This document should be a living resource, regularly revisited, and carefully updated in a controlled manner based on learning throughout the process.
Step 2: Identify and Map Your Stakeholders
A stakeholder is anyone with an interest in or influence on your product or project. Missing input from a key stakeholder is a common point of failure. The lists below are some common stakeholders but are not an exhaustive list.
External Stakeholders: Customers, end-users, suppliers, partners, and regulatory bodies.
Create a stakeholder map to categorize individuals and groups based on their level of influence and interest. This helps you prioritize engagement and tailor your communication strategy.
Step 3: Choose Your Elicitation Techniques
There is no one-size-fits-all method for collecting requirements. Use a mix of techniques to gather comprehensive information:
Interviews: One-on-one conversations are great for understanding individual needs and complex details.
Observation: Ethnographic studies and usability analysis can expose current problems or identify opportunities that a product might solve, but that users and other stakeholders might not be able to see or articulate.
Focus Groups: Facilitated group sessions are effective for brainstorming, resolving conflicts, and building consensus among stakeholders.
Surveys: Use questionnaires to gather input from many stakeholders efficiently, as long as the requestions are articulated to avoid injecting bias and responses are interpreted carefully.
Document Analysis: Review existing business plans, market analysis, and technical specifications to extract relevant requirements.
All of these techniques are powerful but can be risky in the hands of inexperienced personnel.
Step 4: Document and Organize Requirements in a Centralized System
As you gather requirements, you must organize them in a way that is accessible, clear, and traceable. A scattered process makes it impossible to see dependencies, track changes, or ensure complete coverage.
The most important part of this step is moving away from manual methods and toward a single source of truth that applies a systematic approach and automation to maintain control and visibility.
Step 5: Review, Refine, and Validate
Collecting requirements is not a one-time event. It’s an iterative process, and work products can span generations of products and product lines. Once documented, requirements must be reviewed by stakeholders to ensure they are clear, accurate, and complete. This feedback loop is critical for refining the product or project definition and gaining formal sign-off before development begins.
Other Key Considerations
What is the difference between collecting, gathering, and eliciting requirements?
While often used interchangeably, “gathering” or “collecting” can imply simply accumulating information sitting around waiting to be picked up. “Eliciting” suggests a systematic and organized process of soliciting, documenting, and managing requirements from various sources to build a complete and validated set.
How can I ensure I haven’t missed any key stakeholders?
Start by brainstorming all possible groups and individuals affected by the project, both inside and outside your organization. Review past projects of a similar nature to see who was involved. A key practice is to ask the stakeholders you’ve already identified, “Who else should we talk to?”
What’s the biggest risk of a poor requirements collection process?
The biggest risk is building the wrong product. Missing or misunderstood requirements can lead to a final product that doesn’t meet customer needs or business goals, rendering the entire development effort a waste of time and money.
Can AI help speed up the process?
Yes, Generative AI can be useful in suggesting requirements and uncovering gaps in requirements already identified. Be prepared to store suggestions that are outside the scope of the current project for possible use in future ones.
To ensure that your process for eliciting requirements for complex products or projects goes smoothly, use a modern tool designed specifically for that purpose. Jama Connect® is designed to address the core pain points of requirements elicitation by providing a collaborative, single platform accessible to all your stakeholders from the start through the end of your project, as well as across product lines and product generations
With Jama Connect, you can:
Centralize Everything: Create, review, validate, and verify all requirements in one place, eliminating the chaos of documents and spreadsheets.
Improve Stakeholder Collaboration: Bridge silos between teams and provide all stakeholders with real-time visibility into goals, progress, and interdependencies.
Enhance Requirement Quality: Use the Jama Connect Advisor™ add-on to Jama Connect to author and analyze requirements for clarity and consistency against industry standards, including the EARS syntax. Natural language processing (NLP) helps you write better requirements from the start, avoiding ambiguity that leads to costly rework later.
Ensure Traceability: Easily track relationships between requirements, test cases, and risk analyses to understand the impact of any change.
Don’t let scattered documents and manual tracking derail your requirements elicitation activity. A systematic approach supported by the right tool is the key to developing complex products successfully.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mark Levitt and Sarah Crary Gregory.
Jama Connect® Features in Five: Semiconductor Solution
Steve Rush: My name is Steve, Principal Solutions Consultant for Semiconductors here at Jama Software. I’m happy to showcase our new Semiconductor Solution for Jama Connect. It gives companies a head start on their Jama Connect implementation, shortening time to value on their investment. Subsegments like integrated device manufacturing, IP, fabless, and design companies can use this solution out-of-the-box from day one. It can also easily be tailored for manufacturing use cases. The solution itself is made of multiple components.
First, there is a new suite of project templates. These illustrate best practices for data model setup and project organization tuned to the semiconductor industry, robust traceability, IP block and IP core examples, and much more.
Our new community space includes process documentation, importable templates and reports, curated marketing assets, and details on common integration use cases for the semiconductor industry.
Rush: Let’s take a tour of the new projects that come with the semiconductor solution for Jama Connect. You’ll see a few new sets of projects that come with this instance of Jama Connect. First are some automotive examples, one with mock example data, another with microcontroller data showing what an automotive semiconductor project might look like for a particular microcontroller, and then a template that goes along with it for easy copying for a new project.
Our flagship project, which I’ll demo here for you in a second, is the integrated semiconductor system example with GPU data and then the template that goes along with it for easy copying for reuse. And then finally, the semiconductor example data project and template that goes along with it for a hardware-only project.
Let’s take a deeper look at the flagship project, the integrated semiconductor system example with GPU.
This project comes with a new data model honoring the systems engineering bee, illustrating how we decompose the system from a high-level stakeholder Market Requirements Document (MRD) all the way through a a post silicon validation.
High-level stakeholder requirements are derived into system requirements. We call this a Product Requirements Document (PRD) in the semiconductor context. Architectural elements can be linked to the system requirements for allocation. System requirements are distilled into hardware or software domains, respectively.
And then we capture design information as well for those particular domains, separating the requirements from the design, the requirements describing what the system shall do, and the design, how the system will do it. We also have an example project for managing IP blocks or IP cores with a separate hardware block requirement type, design details, and a datasheet item.
The datasheet item can be used to manage key features of that IP core, which we keep separate and distinct from the requirements item. And then finally, verification and validation for both the stakeholder MRD and PRD levels, as well as pre and post-silicon verification and validation, respectively. You’ll see a project dashboard with some useful widgets, a full requirement breakdown by type, stakeholder requirements MRD rolled up by status, post silicon GPU validation by test case status, and then several examples of filters that are finding gaps in my traceability. This will allow teams to help understand requirements, missing certain coverage, and help them manage risks, changes, and exceptions within the project. The project tree now contains new enriched sample data.
At the stakeholder MRD and PRD levels, you’ll see a folder breakdown helping teams store and manage things such as sustainability, regulatory, and security requirements.
The project structure reflects best practice for organizing your project data, and it includes robust traceability examples that show prospects and customers what complete traceability looks like within Jama Connect.
Rush: Using Live Trace Explorer™, you can open up sections of the project to see the traceability score, and you’ll see that this one has a one-hundred percent score with complete traceability.
The IP block section provides examples of several IP projects in FP64 computer core and HP M3 memory. These are derived from the system-level requirements, and they come with their own mini model and setup. You will see examples of functional and parametric requirements, detailed design examples, as well as post pre and post-silicon testing and their respective phase gates. We’re also excited to announce a new procedure guide, which you can use with these new templates. These recommend best practices and recommended steps for using Jama Connect for an integrated semiconductor systems project. You’ll see instructions for managing things like the high-level MRD from conception all the way through baseline work product. You’ll also see instructions and examples for reusing those IP blocks in another project or context.
Thank you very much. We’re excited to deliver more examples and content for the semiconductor industry with Jama Connect.
Impact Analysis: The Key to Proactive Change Management Success
When consulting with clients, I often convey that there are two types of change management in product development:
Proactive Change Management
Reactive Change Management
Suspect triggers and suspicion are great examples of “reactive change management.” Something changed upstream, and you are notified so you can react.
You may ask, “Mario, wouldn’t it be ideal to react and prepare for change BEFORE it happens?” I would then shake your hand, nod my head in proud agreement, and we would be off to enjoy a festive beverage together.
This describes proactive change management, often referred to in requirements management by its function: “Impact Analysis.” When you take the time to build proper trace links across your requirements, you gain a view of all downstream impacts BEFORE you make a change.
It effectively allows you to notify your teams to prepare for the change and provide details so that when it happens, you can reduce risk and maintain compliance.
In the “old days” of the 1900s, you would handle this by calling all your cross-functional team representatives into a conference room and getting their sign-off. Hopefully, they were paying attention and not on their BlackBerrys or Palm Pilots.
In the modern world, impact analysis is essentially the click of a button, showing you all related downstream items, multiple levels deep—including verification and validation.
Collaborative features such as “discussions,” “subscribing,” and “review and approval” allow for formality in this process, collaboration, and official sign-off (with audit history). For significant changes, this gives teams time to discuss and prepare.
When I work with clients and there are features we are building internally that I know will be useful for them, I often “subscribe” myself to the relevant requirements. This way, if there is an update or status change, I automatically get notified via email.
This keeps me connected to the development process without even having to go into a tool. If I want more information, I simply click on the link and log in.
The Takeaway:
Suspicion catches the change after the fact, forcing teams to react. Impact Analysis allows you and your teams to PLAN for a change BEFORE it happens.
Build strong traceability, accept that change is inevitable, and take a proactive approach to your requirements management change process.
Change Management Best Practices: Protecting Your Software Tests
In the world of software development, ensuring the quality and reliability of a product is paramount. Yet, as teams face increasing pressure to deliver more features faster, maintaining disciplined processes can become a challenge. This is especially true when it comes to managing changes and ensuring that tests remain accurate and up to date.
The Value of Traceability
Traceability is a cornerstone of effective software quality management. By mapping feature requirements to test cases, teams can establish a clear connection between what needs to be built and how it will be validated. This approach not only ensures comprehensive test coverage but also enables teams to quickly identify and update tests when requirements change.
When supported by a requirements management tool, traceability becomes even more powerful. Features like traceability matrices and suspect triggers allow teams to see exactly which tests are impacted by upstream changes. This visibility enables faster reactions to changes, reducing the risk of defects slipping through the cracks.
However, as development teams grow smaller and the demand for rapid delivery increases, maintaining this level of discipline can become difficult. Detailed specifications may become less frequent, and the traceability between requirements and tests can erode.
Without traceability, managing changes becomes a manual and error-prone process. Late-stage changes, if not communicated effectively, can introduce regressions that go unnoticed until after release. This can lead to critical defects being discovered in the field, often by customers, which can have significant financial and reputational consequences.
The Cost of Defects
The cost of addressing defects increases exponentially the later they are discovered in the development lifecycle. Defects found during early stages, such as requirements definition or initial testing, are far less expensive to fix than those identified after release.
When defects are discovered in production, the impact extends beyond the immediate cost of fixing the issue. It can involve customer dissatisfaction, increased support workload, and even audits or reviews of the development process. These situations are not only costly but can also damage trust and relationships with key customers.
To avoid these pitfalls, teams must prioritize traceability and leverage tools that support it. Requirements management tools with built-in testing capabilities can provide features like suspect triggers, which notify teams of changes and help ensure that tests remain aligned with requirements.
By staying informed and proactive, teams can prevent costly mistakes and maintain the quality and reliability of their products. Traceability is not just a best practice; it’s a critical safeguard against the risks of rapid development cycles.
Looking Ahead
Proactive measures like traceability and impact analysis are essential for managing change effectively. In the next article, we’ll explore how impact analysis can help teams stay ahead of change and ensure that their processes remain robust.
Until then, remember: good tests deserve good processes. Don’t let bad things happen to them.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mario Maldari.
Unlocking the Power of Jama Connect Interchange™ and MathWorks Integration
Keeping requirements and engineering tools in sync is crucial for effective product development. In complex product development, connecting requirements management with engineering tools is crucial for success.
When teams work in disconnected environments, the risk of errors and compliance gaps grows. An integration between Jama Connect Interchange™ and MathWorks tools like MATLAB and Simulink bridges this divide, creating a seamless, bidirectional flow of information. This connection ensures every team member, from system architects to design engineers, works in alignment with the most current data.
This powerful integration offers significant benefits that streamline development cycles and improve product quality. By automating the exchange of requirements and design data, teams can achieve greater efficiency and collaboration.
Key advantages include:
End-to-End Traceability: Create a clear, auditable link from high-level requirements to detailed model elements.
Reduced Errors: Minimize manual data entry mistakes and miscommunication between teams.
Streamlined Collaboration: Enable systems and design engineers to work together effectively in their preferred tools.
Time and Cost Savings: Automate processes to shorten development cycles and allow teams to focus on innovation.
WATCH THE FULL DEMO BELOW
VIDEO TRANSCRIPT:
Patrick Garman: Hello, my name is Patrick Garman. In this demo, I’m going to walk through an example of using Jama Connect Interchange to share requirements with MathWorks tools, then bring that information back into Jama Connect® for complete traceability. Here’s what you’ll see.
First, I’m going to export a set of requirements from Jama Connect to a ReqIF file using Jama Connect Interchange. Next, I’ll import that ReqIF file into the requirements editor in MATLAB and link those requirements to model elements in Simulink. Once those links are in place, I’ll use MATLAB’s native ReqIF export feature to create a new ReqIF package that includes both the requirements and their Simulink connections.
Finally, I’ll import that ReqIF file back into Jama Connect using Jama Connect Interchange, which will update any requirements that were edited in MATLAB, and also create a new set of model items in Jama Connect to represent the Simulink model elements.
By the end of this process, you’ll see how Jama Connect maintains end-to-end traceability between requirements and model elements, bridging the gap between systems engineering and model-based design. So here I have a Jama Connect project, and you see I have a set of functional requirements here. And these are some requirements that I want to link to elements of a model that I’ve built in Simulink. And I’m going to start this process by exporting these requirements into a ReqIF file. And ReqIF file is essentially an XML file type, but it is a format that is specifically designed to be a standard file type for requirements management tools to enable this kind of exchange of information.
Garman: All right, so I’m gonna start. I’ve already connected my Jama Connect instance to my Jama Connect Interchange. And so I’m going to come to our conversations page, and I’m going to start a new conversation. Just gonna give it first, I need to tell it what tool I’m going to be connecting with, and so we’re going to go with Simulink. And next. And then we need to pick if we have more than one Jama Connect connector, we’ve gotta tell it which one we want to export and import with, and then we just need to pull the project ID. So here we can see this is project two fifty one. So I can search by project using the API ID, or I can use a text search using this drop-down menu.
So this project is a Simulink demo. There we go. Just type a few letters. It pops up for me. And then I’m gonna give my conversation a name, and this is how I can know if I’m having several projects or even several sections of a project that are exchanging information with Simulink. We want to have separate conversations for those. So now I’ve created the conversation space in Jama Connect Interchange, and I want to start by exporting. So I’m gonna come to my export page. And here, I’m gonna start by selecting a location.
Step one: Location. There are a few different ways that our locations can export a baseline. For this situation, I’m going to stick to the container and I’m going to select my functional requirements, even that set of. So I need to select either the project root or a component, and I’ll have a chance to filter items out. But here, I’m gonna select this component and click next. And within that, if there were other sets of items, I could filter those out, but this is the one that I want. So I’m going to save.
Now then, on export, there is field mapping that I can select. For example, if I had more than one item type, more than just functional requirements, I could select which item types I want to include. But I can also set which fields I want to keep for each of these. So there may be several fields that I just don’t care about bringing into MATLAB Simulink because they’re not relevant to the work that I want to do there. Or I just don’t need them and that other thing. So I can turn off any of these fields that I don’t care about or don’t need to have in in Simulink. So I’m only exporting the specific data that I want to import into Simulink.
Alright, so in this case, I’m really just keeping the name, description, and rationale fields. So I can save that export mapping, and Jama Connect will also capture all of your relationship types just in case we again we’re pulling the relationships back in, but those are all mapped automatically. So from here I can just initiate export. And confirm. And depending on how many items this is, you know, six or seven items, it’s going to be really fast. Depending on how many items you are trying to export into ReqIF, that could potentially take longer. But from this log screen, can see the progress, especially if you use the funnel icon, include debug, it brings in, it gives you some status, but ultimately, it gives you this link where you can download the ReqIF file. So here, I’m just gonna drag and drop that onto my desktop so I can find it. And now I’m going to switch over to MATLAB. So starting here in Requirements Editor, because I need to import those requirements that I did previously. Here, I’m gonna delete. So for that, I’m going to first clear out what I had done previously. I can’t do that. So I’m just gonna import. We are importing from ReqIF, and I’m just gonna browse to find the file that I saved to my Desktop.
Garman: So here we have that ReqIF I just created from Jama Connect. So we’ll open that. In these other settings, MATLAB automatically selects some things. I would say, you know, it automatically detects that it’s coming from Jama Connect. If you want to save this in a different location, you can do that here. Ultimately, we’re going to import these requirements. Alright. So here I have my second import, and you can see that these requirements have come through. Now then, I export the description rationale field. So why are they not showing up here? Because this is the MATLAB description and rationale field. For those Jama Connect elements, we need to come down here to custom attributes. And here we can see all of those, all of those fields as set that we exported. Alright. Now that we’re in MATLAB, this is our model that I want to start connecting things to. So in MATLAB, I’m going to select a model element here at the controller. And we will say that one point one is the one, so I can just right-click it and link from the controller. And I could even say, here we go, my Dryden Wind gust models are part of one point three. So again, I can create the link there. And let’s do one more. Let’s do this small gain one. We’ll link that to one point six. Okay. So now we’ve made we’ve added all of our links And and so now what we want to do is we want to take what we’ve done, I want to save it, but then I’m going to export this back to ReqIF.
Here, I can just reuse the original mapping from Jama Connect. If there are, you know, attributes that you want to remove, you can do that here. But the most important thing is we want to export links. So make sure that this export links box is checked, and then we can set a location. I’m gonna move this to our desktop again for easier finding. When we’re ready, we can just click export. So it’s running through everything. It’s gonna save that to our desktop. So, what we can do now is let’s come back to Jama Connect Interchange, and I’m going to switch to import because now we’ve pulled that data from MATLAB and Simulink and we want to bring it into Jama Connect. So I’m gonna go to my import in the same conversation. Click upload.
I’m gonna select that file that I just pulled out of Simulink. And we’ve already set the location, which we can edit if we need to, but we’re gonna leave it at the same location. And here we’re gonna map for the import. So we want to have our functional requirements mapped back to functional requirements in Jama Connect. And these others, these are those model elements that we want to bring back in. And so I’m gonna bring those in as Models. So I can select what item type in Jama Connect I want to have as a reference to those elements back in MATLAB Simulink. So I’ve turned those on. Now I’m gonna, oops, save our item type mappings. And I can switch to fields. And here, the same thing. I just want to map everything back to what it should be in Jama Connect. So here, I’m looking at those model elements. So we want to create this as a set. And we want to bring in the name of the set to the or the name of the collection from MATLAB to a set name in Jama Connect. But then we also have to establish these object types. So here are just Simulink objects. If we had, say, headers or information items, we could maybe map those differently. But we want to tell Jama Connect the Simulink objects should be brought in as folders, text, or models? And in this case, that’s the actual model elements. So we’ll bring them in as models, which is the item type that we map to in the first step.
So now Jama Connect is going to generate the mapping. So we are gonna pull here are the elements, the metadata elements that are found on these Simulink objects, and we just wanna map these back to an item in Jama Connect. So here description will go to description, name goes to name. And if we want to keep if there is a, you know, key, we could map that to an additional field. But once we’re done, we’re gonna click save.
Garman: Now we will move on to our next item type, which is functional requirements. And, again, functional requirements will come back in as a set. And we really only have to map those fields that we want to update. So here I can just leave that as a name, and here a functional requirement. We’ll go back to the functional requirement. And, again, we really don’t have to map many of these fields back if we’re not actually bringing in field-level updates. So here, I’m just gonna map the name. If I had made changes to the other fields in MATLAB, I would change those here. And the final step, I wanna go to relationships, and I just need to map these back into the appropriate even though they’re originally pulled from Jama Connect, and mapping them back to the relationship types that they were pulled from. The good thing about doing this import mapping is that you really only have to do it once. Once you’ve mapped everything in this conversation, you can just keep reusing this conversation and make updates as necessary.
Okay. Another thing you’ll notice with each of these relationships, have this option to reverse direction. And there, that is because some tools treat traceability in a slightly different direction. So, what is happening right now in Simulink, the way I created those is that the model element is actually upstream of the requirement. But in Jama Connect, we want the requirement to be upstream from the model. So I can just I can fix that by clicking this box to reverse direction. On each of these so that when it brings it in, they will be in the correct the relationships will be in the correct cardinal direction. Alright. So once we’ve done that, we can click save.
And now that we’ve mapped everything, we can initiate import. And Jama Connect is gonna ask us, “Do we want to update existing items?” And that’s what we want to choose for this, because we want to update the existing functional requirements, and those model elements will be brought in as new items. Now then, in future iterations, if we export these functional requirements and these model elements into Simulink again, say we’ve made updates, we want to redo it again, it’ll update the existing models that you’ve already imported. If you select create new items, it will only create new items. It will not update any existing items. So in this situation, I want to update the existing items. So we’ll confirm. And tells us to take a look at the logs page, and it’ll take a little bit for this to finish. So again, we’ll get a complete message when it’s done. But if we want to see more, we can enable this debug option.
And you can see that Jama Connect Interchange is evaluating, and it’s saying like, “look, no field changes happened” with these, so we’re not going to update those. But here we go. We do have a few fields that we had to update, and we’re creating those relationships because again, we linked three items. All right, so let’s go back into Jama Connect, and if I refresh my tree, you see that there’s this additional component here under my functional requirements. If I expand that, I have this set of models. And then here I have each of those models. So here is the controller. And you can see it has a link back to that element, the description field. And it is related to the transfer history with a “Satisfied By” Marker.
And that concludes the demo. You’ve now seen how Jama Connect Interchange makes it possible to seamlessly exchange requirements with MATLAB and Simulink through the ReqIF standard. By moving requirements into MATLAB, linking them to model elements in Simulink, and then bringing those links back into GeometConnect, we’ve established full traceability between the system requirements and the model-based design. This integration helps your teams reduce errors, streamline collaboration across engineering disciplines, and maintain compliance with industry standards. Thank you for watching, and please reach out if you’d like to explore how Jama Connect can support your development process.
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.
Jama Connect® Features in Five: Nuclear Reactor Design and I&C Development Solution
Learn how you can supercharge your systems development process! We always want to be respectful of your valuable time. Still, in this Features in Five video, we do go beyond the promised five-minute format to include an information-packed session, hosted by Vlad Tanasescu, GM, Industrial & Consumer Electronics, Jama Software.
Designing nuclear reactors is a complex, high-stakes process requiring precision, safety, and collaboration. Jama Connect’s out-of-the-box framework simplifies this complexity by guiding engineering teams through requirement decomposition, safety assessments, and risk analysis while ensuring traceability across the entire digital thread.
With AI-driven automation, real-time gap detection, and seamless tool integrations, Jama Connect empowers teams to streamline processes, enhance collaboration, and accelerate time to market, all while maintaining the highest safety and compliance standards.
VIDEO TRANSCRIPT
Vlad Tanasescu: Hi, I am Vlad. I lead our energy business unit here at Jama Software, and today I will walk you through a brief live demonstration of our new out-of-the-box nuclear reactor design and instrumentation and control (I&C) system development framework. Our engineering management platform, Jama Connect, enables an intelligent, guided, and measurable product development approach. In Jama Connect, we use process rules to define end-to-end engineering and design processes. Jama Connect will leverage this process to automatically guide the engineering organization through their development, intelligently measure system and process completion, and automatically detect gaps and risks so that engineers know where to take action.
On a high level, our nuclear reactor design framework starts from the decomposition of the requirements and the parallel decomposition of our designs and architectures from the highest level of the plant all the way to the mechanical and software implementations. The framework natively enables the initial deterministic safety assessment, the classification of initiating events in design-based accidents, the categorization of security and safety functions, and the classification of structures, systems, and components in alignment with the guidance of the International Atomic Energy Agency (IAEA) and local nuclear reactor design assessors.
The framework also includes the probabilistic safety assessment, the accident, and those consequence analysis and the analysis of combined risks. Nuclear reactor design is highly iterative. As our design and construction progresses, we will continuously find new safety and security requirements and functions as well as new reliability requirements and special treatments, all of which will need to cascade and feedback into the functional and non-functional levels of our reactor. Nuclear reactor design practitioners integrate model-based systems engineering, product life cycle management, pipeline and instrumentation diagramming and software development tools to Jama Connect to extend the traceability from the definition of our reactor to how our reactor is being implemented in mechanical software and electronics disciplines.
Tanasescu: These integrations will enable us to programmatically measure traceability and system completion across all of our tools, part of the engineering digital thread. For example, from one of our high-level mission needs, energy efficiency, we can directly visualize the allocation to a plant design coming from a model-based systems engineering solution, and then we can follow the decomposition of the requirement and the plan design all the way down to the mechanical implementation.
For example, from this plan design, we have derived multiple system architectures of the key reactor systems, which are further decomposed into multiple subsystem designs, which are further decomposed into component designs, which are ultimately decomposed into mechanical implementations like parts and key assemblies. This end-to-end traceability across the entire digital thread will enable us to understand the impact of changes starting from a requirement all the way down to the lowest implementation level. For example, if I were to change this energy efficiency requirement, I could run an impact analysis in Jama Connect, and then Jama Connect would show me that multiple design levels would be impacted by the change, but five levels down, I would also be impacting implementations in mechanical parts. I would be impacting safety mitigations and risk mitigations as well as executed tests, which is very powerful to understand before the change.
Jama Connect will use intelligent engineer management features like the Live Trace Explorer to intelligently measure the completion of our traceability across the entire digital thread. These intelligent measurements will programmatically summarize the completion of the decomposition of the requirements, the decomposition of the designs, the test coverage, the risk mitigations, as well as the completion of the implementation of our system. Due to the integrations with other tools like product lifecycle management or model-based systems engineering applications, we can start measuring to what extent our component designs have been implemented in parts or our software requirements in software implementations. For example, here we can see that only 2% of our component designs have been implemented in parts or only 2% of our component designs have been analyzed and taken into account in the initial deterministic safety assessment. These intelligent measurements will enable companies to mitigate, rework and reduce their time to market. We will always be able to understand where we have gaps and risks in our system so that we know where to take action.
Tanasescu: In Jama Connect, we use the project tree to visualize and access all of our engineering data in one view. The project tree will also enable us to set up our product breakdown and systems engineering structure. Here, we can see the key subsystem of the reactor and the balance of plant, each subsystem having its respective requirements, designs, and tests, and then one level down, we can visualize the key components of our subsystem. Each component, including requirements, designs, tests, and mechanical software, electronic specific implementations like parts or software user stories. Our out-of-the-box nuclear reactor design framework also contains data models for the automatic calculations and classifications of initiating events and design-based accidents for the categorization of safety and security functions and for the classifications of structure systems and components. The Jama Connect Nuclear Reactor Design framework will also enable the automatic export of initial, preliminary, and final design safety reports and will enable the programmatic creation of security and safety cases.
Our I&C system development framework is reduced to the scope of the development of nuclear reactor subsystems. And in accordance with standards like EEC or EEC61508, the I&C development decomposition starts at the level of the safety design base. The I&C systems development framework also enables codevelopment. Nuclear reactor OEMs, I&C system T1s, and external engineering partners can use Jama Connect as a central source of truth for the entire design and engineering-related collaboration, and they can use Jama Connect’s intelligent engineering management capabilities to measure system completion and identify gaps across the entire engineering data coming from all the partners from our development ecosystem.
We view the adoption of artificial intelligence as essential for reducing time-to-market and increasing efficiency in nuclear development. Jama Connect’s engineering AI enables engineers to highly automate day-to-day and manual tasks like the definitions of tests or the decomposition of requirements. For example, here I have a requirement related to the nuclear fuel and instead of me deriving the test manually, I will use Jama Connect’s engineering AI to derive multiple tests automatically*, and then Jama Connect’s AI will proceed to derive multiple tests that our engineers could choose to take over and relate in traceability with the requirement.
This way, both the test generation and the traceability creation will be highly automated. Thank you very much for your time. If you want to learn more about our nuclear reactor design and IC system development framework, please visit our website. Thank you.
*Test Case Generation available through our add-on product, Jama Connect Advisor™
