Tag Archive for: Requirements & Requirements Management
Tag Archive for: Requirements & Requirements Management
Accelerate Compliance and Requirements Review with AI
Expert Recommendations at the Click of a Button
Reviewing requirements and their associated compliance material is an essential component of developing a quality product. However, review time can often be consumed by arguing over the minutiae of syntax, grammar, and other secondary aspects of a requirement, rather than the technical subject matter. For many teams, this means their subject matter experts (SMEs) are trapped in debate rather than informing design and progressing the development cycle. With the advent of Large Language Models (LLMs) and Model Context Protocol (MCP), the engineering industry is on the verge of optimizing away from these debates and focusing on critical technical progress instead. By tactically prompting and developing tools that can provide a first-pass review, engineering teams can:
Reduce overhead associated with first pass and draft reviews of requirements data
Free SMEs from the monotony of syntax and grammar
Empower junior engineers to improve their requirement development skills
Hone Engineering Expertise with Personas with AI
Artificial Intelligence (AI), particularly Generative AI, has modernized rapidly. Engineering teams are now deploying personas and agents into their workflows. The use of AI provides many clear benefits; however, there are also looming pitfalls. I have personally noted, while working with customers and in my engineering career, that using a deliberate method that forces the human back into the loop provides more effective results than directly allowing AI to modify requirements.
This is where Jama Connect’s integration with an LLM through MCP improves the engineering workflow. Engineers can develop standardized prompts and personas to review data. With the data reviewed and AI recommendations provided, junior engineers can step back in and make improvements prior to discussing the technical details with SMEs. Therefore, improving the requirement’s first draft quality. Simultaneously, this approach reduces the cost of creating quality requirements by decreasing the reliance on SMEs early on in the process.
Rapidly Deploy AI into Requirements Development Workflows
Throughout engineering, there are common roles and expertise that apply to requirements development. For example, there are known syntactical rules posted by many organizations for how to author a requirement. Rules from each of these sources can be applied systematically to help review requirements. Thus, it reduces debate over whether the requirement is syntactically correct.
Similarly, many roles throughout engineering are well defined by guiding documents, standards, and best practices. Most of these documents are public and accessible via the internet. Therefore, it is straightforward to develop personas that mimic an SME from their respective domain of expertise. These personas can be as simple as textual prompt files or as complex as logic-based scripts that are run and utilized by an AI integration into Jama Connect. For instance, a mechanical engineering persona is informed by NASA-STD-5001 and MIL-STD-1522, among a handful of others, to produce meaningful recommendations.
When authoring a persona, teams can do this natively in Jama Connect as a specific Item Type that includes the response format, list of documents the persona is built around, and other pertinent details. By integrating this information directly into the project where the requirements reside, teams are able to assess and version control each persona and related information. With personas developed, teams can rapidly deploy and redeploy canned expert reviewers to provide recommendations to their requirements. My recommendation is to pair these personas with a custom field within the requirement items. This allows Jama Connect users to see the recommendations made per version of the requirement.
As depicted above, the recommendations from the AI review are simple to understand and actionable. An engineer can process an update to the requirement and execute an additional run of the deployed personas to confirm the updates are satisfactory. Users can feel confident in early drafts of requirements due to this feedback and confirmation cycle. This also enables quick iterations prior to requiring time from SMEs.
A key objective of this approach is to reduce AI hallucinations by directly modifying technical engineering requirements that guide complex design, integration, and test. By doing so, teams reap large benefits through the recommendation cycle, while also minimizing the chance of a late failure due to misguided AI inputs.
The goal of this approach is to reduce time spent on initial requirements drafting. Doing so allows teams to focus their resources on early prototyping, compliance assessments, and other typical early-stage engineering efforts that often become truncated due to requirements development and analysis. As functionality like this progresses, new ways to ensure accuracy and reduce overhead will continue to arise. Keep an eye out for continued explanations and approaches to improve your requirements development and review with Jama Connect and AI.
From Requirements to Test Coverage – Using AI to Strengthen Traceability and Validation
Engineering teams frequently identify verification and validation gaps late in the development process — often during testing, audits, or certification reviews — when addressing them becomes both costly and disruptive. These challenges often stem from earlier stages, where unclear or inconsistent requirements hinder the creation of effective validation scenarios and disrupt the ability to maintain robust traceability between requirements and tests.
Katie Huckett: Welcome everyone, and thank you for joining today’s webinar, From Requirements to Test Coverage: Using AI to Strengthen Traceability and Validation. Today, we’re going to look at a very practical engineering workflow and how improving the clarity of requirements can directly improve validation, coverage, and traceability. Many engineering teams experience problems late in the lifecycle during testing or audits. What we’ll show today is that those issues often originate much earlier in the requirements themselves. I’m Katie Huckett, product line manager for Jama Connect Advisor™. I lead the overall vision and strategy for AI at Jama Software.
When validation failures appear late in the development lifecycle, teams often assume the testing phase is the problem, but in many cases, the root cause started much earlier in the requirements. If requirements are ambiguous or incomplete, engineers may create tests that don’t fully validate the intended behavior. That gap may not become visible until system testing or certification activities, when fixing the problem becomes much more expensive. Before we go any further, we’re curious about your experience. Where do validation gaps typically surface in your organization? Go ahead and select the answer that best reflects your experience.
Many teams find that these gaps surface during system testing or audits, which means the issue has been present for a long time before it becomes visible. Now, why does this happen? There are several reasons these validation gaps occur. One common issue is ambiguous language. For example, if a requirement states that the system should load a page quickly, what does that actually mean? Different engineers may interpret that requirement differently, which leads to inconsistent validation. Another issue is an incomplete requirement structure, where key details needed for validation are missing. Finally, relationships between requirements and tests are not always maintained consistently as systems evolve.
Huckett: This is the example requirement we’ll use throughout today to illustrate this workflow for a hearing aid surgical installation change. “The system should try to ensure that the doctor performs the surgery in three or more sequential stages if needed and completes it before they are done.” At first glance, this seems okay, but it leaves several open questions. What is it or they? How many stages are actually required? How should we validate that the behavior meets the intended design? These kinds of questions are common when requirements are written quickly or evolve over time.
The first step in strengthening validation coverage is improving requirement quality. AI-assisted quality analysis can evaluate requirements and identify issues such as ambiguous language or structural inconsistencies. This helps engineers catch potential problems earlier, before downstream work begins. Now, let’s look at how this works in practice. So let me start here by going into my system requirements, and you can see my surgical installation change requirements right here at the top. All right, let’s go ahead and run an analysis on this requirement. All right, let’s take a look at what the analysis found. And as a reminder, this isn’t about making requirements perfect; it’s about identifying issues that can cause confusion downstream in design, testing, and validation.
Huckett: So right away, you can see we’re flagging multiple issues across INCOSE and EARS guidelines. That’s usually the first signal; if a requirement triggers this many rules, it’s likely going to cause problems later in the lifecycle. One of the first things flagged is the use of “should” and phrases like “try to ensure.” That’s a problem because it weakens the requirement. It’s no longer clear whether this is mandatory or optional. And if it’s not clear, it won’t be clear when someone tries to validate it later. We’re also seeing logical conditions like “or” and “if needed.” These introduce ambiguity because they allow multiple interpretations of what the system is actually expected to do. That’s where teams start making assumptions, and different assumptions lead to inconsistent implementation and testing.
And then again, we have pronouns like “it” or “they.” This might seem minor, but in complex systems, unclear references can make it difficult to trace exactly what behavior is being described. That becomes especially important when you’re trying to maintain traceability across requirements and tests. So individually, these issues might seem small, but together they make the requirement hard to interpret, harder to validate, and harder to trace. And that’s where we start to see gaps showing up later in testing. So instead of manually rewriting this from scratch, we can use our Requirement Refinement feature to generate a cleaner version of this requirement. So let’s go ahead and kick off that process. Okay, here’s the suggested rewrite. We have a couple of options here. “The system shall facilitate the surgery to be conducted in a minimum of three sequential stages,” and “The system shall ensure the surgery is completed within the designated timeframe.”
Unlock Static Data and Accelerate Development by Using Raiqon PDF Converter with Jama Connect
Raiqon and Jama Software have partnered to address the friction caused by static PDF files in agile development environments. Although PDFs remain a standard for exchanging product requirements and RFPs, they often stall progress due to a lack of structure and fine-grained traceability. This disconnect forces teams to rely on cumbersome manual processes that increase the risk of error, slow down product development cycles, and make rigorous change management difficult to achieve.
Using Raiqon PDF Converter with Jama Connect provides an elegant bridge between legacy documentation and modern digital engineering. PDF Converter digitizes static text, complex tables, and images into structured ReqIF, Word, or Excel data files that maintain the original hierarchy and context. By automating this conversion, organizations can ensure that every requirement is digitized accurately for importing into Jama Connect, using Jama Connect Interchange™ for ReqIF.
KEY BENEFITS
Automate Requirement: Imports Replace tedious manual data entry with intelligent parsing that digitizes PDF content into structured requirements, accelerating R&D, saving valuable engineering time, and improving quality.
Maintain Data Fidelity: Ensure complete accuracy by importing tables, images, and formatting exactly as they appear in the source document for compliance and add searchable metadata for efficiency.
Scale Document Processing: Handle large-scale projects easily with a robust solution capable of processing documents with more than 1,000 pages.
Streamline Compliance: Convert isolated document text into traceable items within Jama Connect, supporting rigorous regulatory standards and improved risk management.
The Raiqon PDF Converter can be used as SaaS in the secure Raiqon cloud or installed in private clouds or even on premises (requires availability of GPU). After uploading a PDF document to the PDF Converter, advanced algorithms identify and segment requirements, headings, and visual elements. Optical character recognition (OCR) is applied to capture data trapped in images. Users can review the parsed content, adjust hierarchies, or correct text classifications to ensure precision. Once approved, the software exports a clean ReqIF, Word, or Excel file that is mapped to specific fields, allowing for a smooth import into Jama Connect, directly for Word and Excel, and using Jama Connect Interchange for ReqIF, that retains all structural logic and relationships.
To learn more about how using Raiqon PDF Converter with Jama Connect can reduce time and improve quality of your product development, visit jamasoftware.com
LEX Diagnostics Boosts Efficiency by Modernizing its Requirements Tool with Jama Connect
“It’s very compatible with the sort of startup model where everybody will be doing a little bit of everything. The person with the best skill set is the one who solves a particular problem.” – Tim Schuller, VP of Engineering, LEX Diagnostics
About LEX Diagnostics
LEX Diagnostics is redefining point-of-care diagnostics with its ultra-fast PCR system. Their launch product, the VELO system, delivers positive results for Flu A, Flu B, and COVID-19 in as little as six minutes, enabling cost-effective decisions during a single appointment.
Customer Story Overview
After inheriting an existing requirements management tool, LEX Diagnostics sought to modernize their approach. Switching to Jama Connect provided a user-friendly platform with direct product support and flexible licensing that aligned with their agile goals.
With Jama Connect, Users Experience:
A Modern, Intuitive Interface that empowers users to manage requirements, create documents, and enhance collaboration without a steep learning curve.
Flexible Licensing and Widespread Adoption that allows the entire team to contribute to projects, creating a single source of truth and improving internal knowledge sharing.
Responsive, Expert Support that provides clear answers and reliable timelines, saving weeks of project time and eliminating administrative delays.
LEX Diagnostics encountered hurdles in integrating their existing tool with their agile, startup environment. The team identified several areas where an improved solution could better support their workflows and rapid development pace.
Need for Responsive Support Jama Software’s flexible support model was a key advantage at important points in LEX’s development journey allowing the company to avoid manual workarounds which had historically been necessary and highlighting the importance of a partner that provides direct and timely product support.
Complexity Impacting Usability The LEX team found the Jama Connect interface easy and intuitive to navigate, which encouraged adoption by users who weren’t full time administrators resulting in the tool being more widely used across the organization. Jama Connect reduces the steps required to execute routine tasks, saving LEX significant time and money.
Need for Scalable Licensing Startups like LEX thrive on agility and collaboration, requiring tools that adapt to their dynamic workflows. Thanks to a flexible licensing model, Jama Connect allowed the entire team to participate directly in the development process, ensuring that critical reviews and updates happened within the platform itself. The software removed barriers to access and kept everyone aligned with a single source of truth.
“Our head of software…just figured Jama Connect out himself in about 15 minutes. It’s just night and day with simplicity.” – Tim Schuller, VP of Engineering, LEX Diagnostics
Solution
LEX Diagnostics decided it was time to update its requirements management tools and chose Jama Connect, supported by internal champions with positive prior experiences with the platform.
Seamless Onboarding and Hands-On Support: Following a trial where the team could test the platform’s full capabilities, Jama Connect’s tailored onboarding and hands-on support ensured a smooth transition.
An Intuitive, User-Friendly Platform: The simplicity of Jama Connect offered immediate value to the engineering team, allowing them to focus on innovation rather than tool management.
A Flexible Licensing Model: Jama Connect’s flexible licensing model, including unlimited reviewer seats, suited LEX Diagnostics’ startup environment, fostering collaboration across departments.
“It’s a useful confidence boost to see that the workflows we’ve built in Jama Connect closely align with standard medical device and regulatory workflows, reinforcing trust in our approach.” – Tim Schuller, VP of Engineering, LEX Diagnostics
Since adopting Jama Connect, LEX Diagnostics has seen significant improvements in its processes, team morale, and confidence in meeting regulatory requirements.
Improved Adoption and Internal Knowledge: Flexible licensing has driven widespread adoption. Teams now use Jama Connect for internal software and hardware development — projects they previously managed in disparate documents. “It’s very compatible with the sort of startup model where everybody will be doing a little bit of everything,” Schuller explained. “The person with the best skill set is the one who solves a particular problem.”
Increased Efficiency and Reduced Timelines: The direct support and user-friendly interface have streamlined administrative tasks. Schuller estimates the responsive support from Jama Connect saved four to five weeks of potential delays. When the FDA requested further details during review of their 510(k) submission, generating documents from Jama Connect was faster and easier.
Enhanced Regulatory Confidence: With built-in templates aligned with standards like ISO 14971, Jama Connect gives the team a validated framework for their workflows that has provided a “useful confidence boost.” The ability to easily version changes within the platform has also freed them from manual paperwork tracking and potential audit complexities.
Streamline Standards Compliance: Automate the traceability required for standards, significantly reducing the manual effort of audit preparation.
Support Secure-by-Design: Seamlessly incorporate cybersecurity planning and controls from design initiation to ensure compliance with EU Cyber Resilience Act requirements.
Adopt Agile Approach to Contextualize Functional Safety Assessments: Customize assessments to fit each specific product or iteration instead of using the same preset list of hazards and responses for every project.
Unify Risk Management: Integrate hazard analysis (HARA) and Failure Mode and Effects Analysis (FMEA) directly into the development process to ensure safety risks are identified and mitigated early.
Enhance Multi-Disciplinary Collaboration: Align mechanical, electrical, and software teams on a single platform to prevent silos and ensure system-wide coherence.
Accelerate Variant Management: Manage product variants efficiently to meet specific customer specifications without sacrificing speed to market.
Ensure End-to-End Traceability: Maintain links between requirements, risks, and tests to ensure every design decision is verified and validated before release.
Simplify Complexity, Risk Assessment, and Safety and Cybersecurity Compliance with Jama Connect for Industrial Machinery Development
Developing modern industrial machinery involves navigating a dense web of complexity where precision is paramount. Engineering teams must synchronize mechanical, electrical, control, and software components while adhering to rigorous safety and security standards like ISO 13849-1 and 2, IEC 62061, IEC 61508, and IEC 62443. The pressure to deliver tailored product variants rapidly often conflicts with the need for thorough risk assessment and documentation. Without a unified approach, gaps in requirements can lead to costly delays, safety incidents, or field recalls, threatening both market reputation and operational efficiency.
Jama Connect for Industrial Machinery Development provides a robust, pre-configured framework designed to tame this complexity. By aligning directly with major machinery and functional safety and security standards, the platform creates a clear digital thread from high-level stakeholder requirements down to specific component verification. This solution bridges the gap between diverse engineering disciplines, ensuring that control systems, safety functions, and mechanical designs evolve in lockstep. Teams manage the entire product lifecycle — from concept to validation — within a single source of truth that actively monitors for compliance and risk.
Jama Connect for Industrial Machinery Development includes the following:
End-to-End Traceability. The out-of-the-box, customizable Traceability Information Model™ starts right at the top with every stakeholder or customer requirement tracing back to a specific standard or clause. This traceability provides teams with a clear link between what they’re building and why it’s required, and detailed documentation for auditors.
Functional Safety Compliance. The classic V-model structure covers stakeholder to system, subsystem, component, design, and then test for a clean, end-to-end chain that mirrors the safety lifecycle — define it at the top, prove it at the bottom.
Integrated Cybersecurity Framework. Identify relevant threats and vulnerabilities using pre-defined templates to align threat analysis with security requirements and verifications, enabling teams to respond to incidents quickly at all stages of the product lifecycle.
Risk Management. Each use case connects into a hazard analysis or FMEA, which flows naturally into safety function requirements. That means that identified risks turn directly into design actions, not just documents that sit on the shelf.
Control Systems Safety. Safety functions break down into the safety-related parts of the control system — electrical, electronic, or software layers, where things like Performance Level or SIL come into play.
Verification and Validation. Every safety function, every requirement, has a clear link to the tests or activities that prove it’s been met.
From standards, threats, and risks all the way through design and verification, everything is connected. It makes compliance smoother, audits faster, and the overall process a lot more reliable and efficient.
Example of Hazard Analysis Trace Matrix
Companies choose Jama Connect for Industrial Machinery Development to innovate faster and deliver complex, safety-critical machinery with confidence, knowing that every requirement is met, tested, and documented for the global market. To learn more, visit www.jamasoftware.com
Jama Connect Named Best Requirements Management Software for 2026 in G2’s Spring Grid Report
Jama Connect once again recognized as the best requirements management software by G2’s Grid® Methodology
Jama Connect, the leader in requirements management software, has been recognized once again as the Best Requirements Management Software in the G2 Spring 2026 Grid Report. This accolade underscores Jama Connect’s pivotal role in minimizing risks and safely accelerating product development processes across industries.
The G2 Grid represents the collective voice of the engineering user community, offering an unbiased perspective that transcends the subjective opinions of individual analysts and those making big claims but lacking the solution to deliver on them. Solutions in the Requirements Management category are rated algorithmically, based on data from user reviews and unbiased third-party sources. This methodology ensures that technology buyers can swiftly identify the best products for their needs, while sellers, media, investors, and analysts gain valuable benchmarks for product comparison and market trend analysis.
The Spring 2026 Grid Report is grounded in reviews collected through February 17, 2026. G2 employs unique algorithms to calculate Satisfaction (v4.0) and Market Presence (v7.0) scores, providing a comprehensive view of the market landscape. For the latest data, users are encouraged to visit G2’s website.
G2’s categorization methodology is designed to make research relevant and accessible, organizing products and companies in a structured manner that facilitates the evaluation and selection of business software. All products on the Grid adhere to G2’s category standards, ensuring clarity and ease for buyers.
“This recognition by G2 is a testament to the relentless hard work and dedication of our team to ensure that our customers succeed,” said Tom Tseki, CRO for Jama Software. “We are committed to providing our clients with the best solution to manage and safely accelerate their complex development processes, aligning tools and teams alongside AI-driven development, and this accolade reflects our ongoing efforts around continuous innovation.”
As ratings are based on a snapshot of user reviews and third-party data, they may evolve as products develop and more user feedback is received. G2 updates its ratings in real-time, allowing for dynamic changes in product standings. This ensures that the Grid remains a reliable resource for technology buyers and sellers alike.
Frequently Asked Questions about Requirements Management Software
What is the best requirements management software?
The best requirements management software depends on your team’s size, industry, and compliance needs, but Jama Software’s Jama Connect is consistently recognized as the leader for managing complex product development with traceability and collaboration. Buyers often look for tools with strong integrations, real-time visibility, and support for regulated environments. Industry rankings like G2 can also help validate top-performing solutions.
What should I look for when buying requirements management software?
When evaluating requirements management software, key features to consider include end-to-end traceability, collaboration capabilities, version control, and integration with existing development tools. Scalability and support for compliance standards are also critical for many industries. Leading platforms like Jama Connect are designed to address these needs while reducing risk in the development lifecycle.
What is the most scalable requirements management software?
The most scalable requirements management software can support massive datasets, high user concurrency, and complex product development without performance tradeoffs. Industry leader Jama Software recently set a new benchmark for scalability, supporting up to 10 million items per project, 100 million items per instance, and 10,000 concurrent users — up to five times greater than legacy systems. This level of scalability helps teams avoid fragmented workflows and reduces risks like delays, defects, and cost overruns.
Why is requirements management important in product development?
Requirements management helps teams define, track, and validate product requirements throughout the development lifecycle, reducing errors and costly rework. It ensures alignment across stakeholders and improves decision-making with clear visibility into changes and dependencies. Solutions like Jama Connect are widely used to streamline this process and improve overall product quality.
What industries use requirements management software?
Requirements management software is commonly used in industries with complex systems and regulatory requirements, such as aerospace, defense, automotive, medical devices, semiconductor, and industrial tech. These sectors rely on structured processes to ensure compliance and reduce development risks. Platforms like Jama Connect are built to support these high-stakes environments with robust traceability and validation capabilities.
Jama Software is focused on accelerating product velocity with AI-driven development across multidisciplinary engineering organizations. Using Jama Connect, engineering organizations can now adopt AI-driven development while intelligently managing the complexity and compliance of parallel development, automated pipelines, and industry standards. Our rapidly growing customer base spans aerospace & defense, automotive, medtech & life sciences, semiconductor, industrial manufacturing, consumer electronics, infrastructure, robotics, and energy. For more information about Jama Connect services, please visit https://www.jamasoftware.com.
What Is the Systems Engineering Process? A Guide for Complex Programs
The best-run complex programs share a common trait. They use a structured systems engineering process to keep hardware, software, and human factors teams aligned from concept through retirement. That alignment comes from having clear interfaces between disciplines and verification evidence that stays connected at every level.
We’ve seen this across aerospace, defense, automotive, and medical device programs. Teams that invest early in structured requirements and traceability catch conflicts before integration and keep compliance evidence audit-ready. Without that investment, gaps tend to surface at the worst possible time.
This guide covers what the systems engineering process is, the key phases and lifecycle frameworks, how requirements management and the V-Model support it, and where teams most commonly run into trouble.
What Is the Systems Engineering Process?
A systems engineering process is a cross-discipline approach to making sure hardware, software, personnel, and procedures all work together across the full lifecycle of a complex product or system. Most engineering disciplines go deep in one domain. Systems engineering works across all of them, managing the tradeoffs between disciplines and defining the interfaces that connect them. When a satellite program has 15 subsystem teams in parallel, someone needs to make sure the thermal engineer’s constraints don’t conflict with the power engineer’s allocation.
Most failures in complex programs trace back to broken relationships between requirements, interfaces, and verification activities. That’s what the process is for. It keeps those connections intact so problems don’t show up for the first time during testing or an audit.
Why a Systems Engineering Process Is Important
Programs that spent under 5% of total cost on requirements engineering experienced 80% to 200% cost overruns, while those investing 8% to 14% met their budgets. Incomplete requirements are one of the most common reasons projects fail or stall. The specifics look different across industries, but it always comes back to the same thing. If teams don’t get requirements right early, they pay for it later.
For teams building regulated products, the consequences go beyond budget. Defense program audits have found cases where programs couldn’t show a clear link between their requirements and the work they actually delivered. When requirement baselines drift and interfaces get defined in different places, traceability gaps turn into compliance problems that take months to close.
Key Frameworks and Standards
If you’re working in defense, automotive, or medical devices, you’ll run into these frameworks repeatedly:
ISO/IEC/IEEE 15288:2023: Establishes a common framework for describing the lifecycle of engineered systems from conception through disposal, without prescribing a specific methodology.
International Council on Systems Engineering (INCOSE) SE Handbook v5.0: Provides practical application guidance for 15288’s processes across automotive, defense, healthcare, and other domains.
IEEE 15288.1: Establishes systems engineering requirements intended to form the basis of acquirer-supplier agreements for Department of Defense (DoD) programs.
NASA Systems Engineering Handbook: Provides implementation guidance for NASA programs and is one of the most widely referenced SE handbooks in practice.
These standards give teams shared definitions for the practices that break down first under pressure, including requirement baselines, interface control, verification planning, and traceability.
Key Phases of the Systems Engineering Process
ISO/IEC/IEEE 15288 defines 14 technical processes, not rigid sequential phases. The phases below line up with those processes, and systems engineering teams repeat them at every level of the system hierarchy. That’s why requirement and traceability failures are rarely isolated to one milestone.
Concept Exploration and Requirements Definition
Teams define the system’s purpose by identifying who will use, operate, regulate, and maintain it, then developing the Concept of Operations (ConOps) and establishing requirements baselines. Stakeholder identification goes well beyond end users to include program managers, regulators, and anyone with approval authority. If a stakeholder class gets missed here, it tends to surface later as a change request or a verification gap.
Functional Analysis and Allocation
With the purpose defined, teams break system functions into sub-functions, allocate requirements to functional elements, and define the interfaces between them. Trade studies evaluate allocation alternatives. Hidden conflicts start at this stage if allocation decisions are made without clear ownership and interface control, because teams can move fast in parallel and still drift apart if those allocations aren’t visible across the system.
Design Synthesis
Preliminary Design Review (PDR) and Critical Design Review (CDR) are the key decision gates. Teams turn the functional and logical design into a physical architecture and produce the detailed design specs and interface control documents that will guide the build. Weak upstream definition starts getting expensive at this point, because a vague requirement from concept exploration now affects architecture, interfaces, and review readiness.
Implementation and Integration
Configuration and interface control become critical as teams build, code, or procure system elements and start putting them together. Many teams first feel the cost of earlier process gaps here. The integration issue looks immediate, but the cause is often an outdated baseline or an unreviewed change from earlier in the lifecycle.
Verification and Validation
These are separate processes with different objectives. Verification confirms that system elements meet specified requirements (“built right”), while validation confirms the full system actually works the way users and operators need it to (“built the right thing”). Teams struggle here when they try to reconstruct verification evidence after the fact, because weak requirement relationships upstream turn the problem from testing into an evidence gap.
Operations, Maintenance, and Retirement
Systems engineering doesn’t end at release, and neither do traceability obligations. When a mid-life upgrade is planned, engineering activities revisit earlier lifecycle stages depending on the scope. Mature programs still manage changed requirements, updated verification evidence, and new baselines long after initial deployment.
The Role of Requirements Management in Systems Engineering
Requirements management runs through every phase of the systems engineering process and is how teams keep the system definition current while multiple disciplines work at once. This means tracking every requirement from origin through design, implementation, and verification. When a requirement changes, every linked test case, design element, and risk assessment needs updating. Bidirectional traceability is what makes that tracking reliable at scale.
Complex systems can have thousands of requirements across multiple levels for dozens of products. At a small scale, manual traceability feels survivable. At program scale, it becomes a recurring tax on systems engineering, quality, and verification teams, and it still leaves gaps.
The V-Model in Systems Engineering
The V-Model covers the development stage specifically. The left side represents top-down decomposition, where stakeholder needs flow down through system requirements, subsystem specifications, and build-to documentation. The right side represents bottom-up integration and verification, from unit testing up through system-level validation. Teams create verification plans on the left side at the same time as requirements. If verification planning is deferred, teams create the late-stage surprises they end up blaming on integration.
Traceability Across the V
Each left-side definition level maps horizontally to a right-side verification level. Stakeholder needs map to acceptance validation, system requirements to system verification, and so on down to unit level. This correspondence is what distinguishes teams that catch integration problems early from those that don’t. Teams need those connections maintained continuously, not reconciled manually near a milestone.
Other Lifecycle Models
Incremental approaches deliver partial capability earlier, while agile methods like the Scaled Agile Framework (SAFe) manage the tension through Solution Intent, where system requirements evolve alongside the system. The specific lifecycle model a team chooses isn’t what determines success. Every model still has to answer the same questions about baseline control, decomposition, traceability, and verification.
Model-Based Systems Engineering (MBSE)
Traditional systems engineering relies on disconnected documents where requirements live in one tool and design models live in another. Model-Based Systems Engineering (MBSE) replaces that fragmented approach with a unified model that supports requirements, design, analysis, and verification activities across the lifecycle. The primary modeling language, Systems Modeling Language (SysML), reached v2.0 with formal Object Management Group (OMG) adoption in July 2025.
MBSE is gaining real traction across the industry, though published studies still have limited data on how much it saves at the program level. What matters in practice is whether the approach, documents or models, actually helps teams catch inconsistencies earlier and keep their requirements under control.
Common Challenges in the Systems Engineering Process
Three recurring failure patterns show up when teams underinvest in these processes:
Requirements drift and traceability gaps: When requirements change but downstream artifacts don’t get updated, gaps accumulate silently. GAO audits have repeatedly found traceability issues with defense program baselines, with corrective actions sometimes taking over a year to complete.
Siloed teams and tool fragmentation: When requirements live in disconnected systems, bidirectional traceability becomes manually intensive and error-prone. The relationships between artifacts become harder to trust as those tools multiply.
Scaling across multi-discipline programs: The number of handoffs between requirements owners, subsystem teams, system architects, and verification engineers grows fast with program size. What worked with one team starts to break when the coordination surface expands faster than the process does.
All three point to the same underlying problem. The connections between requirements, design artifacts, and verification evidence are either missing or too expensive to maintain manually.
How Jama Connect Supports the Systems Engineering Process
Across every phase of the systems engineering process, the need is the same. Teams have to keep their requirements, design decisions, and verification evidence connected and up to date. When those connections break or go stale, the cost shows up at integration, audit, or both.
Jama Connect® is a requirements management and traceability platform that supports this workflow through Live Traceability™, which flags affected downstream items when requirements change so teams can assess impact and preserve the decision trail for audits. Traceability Information Models give teams pre-built frameworks for standards like ISO 13485, DO-178C, and ISO 26262, so missing downstream artifacts get flagged automatically. Start a free 30-day trial to see how it fits your workflow.
Frequently Asked Questions About the Systems Engineering Process
What is the difference between systems engineering and software engineering?
Software engineering goes deep within one domain. Systems engineering works horizontally across hardware, software, and human factors. A systems engineer manages the interfaces and tradeoffs between those disciplines to make sure a local improvement doesn’t create a problem elsewhere in the system.
What does a systems engineer do?
A systems engineer leads the concept of operations, defines and allocates requirements, evaluates tradeoffs, manages interfaces, and oversees verification and validation. They work across the full lifecycle from concept through retirement and make sure no team improves their piece at the expense of the whole.
What industries use the systems engineering process?
Aerospace and defense, automotive, medical devices, semiconductor, and energy are the most common verticals. Any industry building complex, multi-discipline products with regulatory or safety requirements tends to rely on a structured systems engineering process.
How does systems engineering relate to project management?
Project management handles schedule, cost, and resources. Systems engineering handles the technical content, including requirements, architecture, interfaces, and verification. They’re complementary disciplines that coordinate closely on complex programs.
This blog recaps our webinar, “Best Practices for Test Management” – Watch it in its entirety HERE.
Transform Your Development Lifecycle with Modern Test Management
Building complex systems demands more than just functionality—it requires precision, compliance, and reliability. Verification and validation are the cornerstones of ensuring your product meets industry standards and exceeds expectations.
Traditional testing methods can’t keep up with the growing demand for faster delivery and uncompromised safety in complex system development. In this session, we’ll look at how adopting a modern test management approach can transform the way you develop and deliver complex systems.
JoinRomer De Los Santos, Principal Solutions Manager at Jama Software, for a deep dive into optimizing your testing lifecycle. We will discuss the critical shift toward requirements-based testing and how connecting test status directly to requirements ensures complete traceability and streamlines development.
What you’ll learn:
Achieve end-to-end traceability by linking test results directly to requirements
Ensure compliance and eliminate gaps in your development process
Empower QA teams to validate requirements early, accelerating approvals
Foster seamless collaboration between engineering and quality assurance teams
Gain real-time visibility into test progress to proactively address roadblocks
Leverage data-driven insights to mitigate risks and enhance product quality
Don’t miss this opportunity to improve how you manage verification and validation.
THE VIDEO BELOW IS A PREVIEW – WATCH THE ENTIRE PRESENTATION HERE
TRANSCRIPT PREVIEW
Romer De Los Santos: Hello, everyone. I’m Romer De Los Santos, a principal solutions consultant here at Jama Software, specializing in software development and process improvement for the medical advice and life sciences vertical. Before joining Jama Software, I spent over 20 years developing a myriad of medical devices, including insulin pumps, continuous glucose sensors, diabetes management software, solid-state cardiac spec cameras, genomic sequencers, and IVD genomic assays. Having served in the roles of software developer, test lead, systems engineer, technical product manager, core team lead, and even a short stint as an internal auditor, I have gained firsthand experience in the full development lifecycle and have an understanding of the perspectives of the different stakeholders involved in development. I’m pleased to be here today to present on test management using Jama Connect®.
Jama Connect is a highly configurable requirements management tool that includes robust test management capabilities. I’m happy to share some best practices on how to use those capabilities. This is not intended to be a step-by-step tutorial on how to perform testing using Jama Connect. Instead, I’ll be going over some testing concepts and best practices to help improve your experience with the tool. Then I’ll provide some information on what is possible and how you can extend Jama Connect’s capabilities. First, let’s start with a discussion about the structures around testing in Jama Connect, and how understanding those structures will help you manage your testing effort.
The scope of testing is defined by a test plan, and test execution must be in the context of a test plan. Many users use one test plan per release. However, for more complex projects, it may make more sense to break up testing into one test plan per major component or one test plan per test team. Having a test plan per component allows you to leverage the testing of that component whenever the component is used. Having a test plan per test team allows individual test teams to manage their own testing effort independently, and is often used by very large organizations. Your testing strategy depends on your situation, and if you need advice, please contact your designated Jama Solutions consultant or your customer success manager.
Test plans contain groups of test cases. Jama Connect adds test cases to a cycle of testing by test group and status. The criteria you use for grouping test cases is up to you; however, it is best practice to organize test groups by functional group, which is defined as a feature or functionality that can be independently tested. This type of organization facilitates reuse. For example, say you swap out an imaging module for a genomic sequencer with an equivalent component. Instead of cherry-picking individual test cases, you can rerun the imaging module test group. Now, let’s talk about the structures around test execution.
De Los Santos: A group of test runs is known as a test cycle. Jama Connect will allow you to add to the test cycle by test group, test status, pass or fail, and will even give you the option of cherry-picking from the selected test groups. Test cycles can be run in series or in parallel. If you have a small team, you may choose to run one cycle at a time. If you have multiple test teams, it may be more efficient to have each test team have their own test cycles so that testing can be run in parallel. When running multiple test cycles in parallel, it is best practice to agree on a naming convention to minimize ambiguity when looking at a growing list of test cases. Something like Alpha Team Cycle 1 identifies the team and the current cycle they’re on.
Each test case added to the test cycle will spawn a test run, which captures the execution of the test case. The test run is synchronized with the version of the test case at the time the test cycle was created. If there are any changes after that point, the test run will not automatically update until you choose to resynchronize them. However, doing so will wipe out any progress you’ve currently made on your test run. If you want to keep your progress and continue your work on your previous test case, then don’t sync. Jama Connect allows you to run different versions of the same test case, as long as they live in different test cycles.
Now, this is a good time to talk about the concept of parameterization. Parameterization is when a single test case is run multiple times to verify a specific set of parameters. It’s best practice to duplicate the test case for each parameter so that you have a separate test run per parameter. While this method does increase the total number of test cases in your test plan, it also ensures that each parameter is tested and captured in its own test run, thus eliminating ambiguity in your testing results.
Since Jama Connect is an item-based software solution, you can use item locks to manage your testing effort. If you lock a test plan, you prevent modifications to the test plan, the adding and removing of test cases and the organization of those test cases into test groups. However, testers are still able to create test cycles and execute test runs. They can also choose to synchronize runs to the latest versions of your test cases. In other words, when locking a test plan, you have control over what test cases are run and how they are organized. If you choose to lock a test cycle, you will ensure that testers execute the version of the test case at the time the cycle was created or last synchronized. Thus, locking the test cycle gives you control over the version of the test case to be executed. Finally, if you want to prevent a test case from being run, you should lock the associated test run. This effectively prevents any test execution.
De Los Santos: While Jama Connect is not designed as a dedicated test management tool, it can be configured to be compatible with most testing processes. Let’s go over some of the most useful configuration options available to you. What I’m showing you here is Test Center in Jama Connect. One of the most common requests I receive from my clients is, ” Where can I put a prerequisite or preconditions field in Jama Connect?” Ideally, you want to place it where the description field is located on the test execution tab here. However, you don’t have control over the order of the items that are going to be displayed on the test execution tab.
The best way to accomplish this is to reuse or rather commandeer the description field of your test case to be your new preconditions field. So the way you would do that very simply is you would go to your admin panel, go to item types, select your particular test case item, and then look for a unique field name called description and rename that to be your preconditions field. Any value you enter into your new preconditions field will appear in the description field of the associated test run. All right? So let’s try it out. Let’s go into our project, go under verifications. We’ll pick the first test case and enter a precondition for a prerequisite. This is a precondition. Save that off. When we go back to the test plan and look at the test runs, you’ll notice it’s now out of sync because we updated the test case. We’ll go ahead and resync, and now, when you execute your particular test case, or rather, execute the test run, you’ll see here that the precondition now appears above the test steps.
Jama Connect Features in Five: Risk Management for Medical Device
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
Follow along with this short video below to learn more – and find the full video transcript below!
VIDEO TRANSCRIPT:
Introduction to Jama Connect’s Risk Management Package
Stephen Pink: Hello. I’m Stephen Pink. I lead the medical and life sciences solutions architecture team at Jama Software. And today, I’ll be giving an overview of Jama Connect’s risk management package.
Challenges of Traditional Risk Management
Pink: Risk management is the backbone of safe design, but for many medical device companies, ISO 14971 compliance is buried in static spreadsheets that are disconnected from the actual design data.
The problem with this approach is that risk management happens in a silo. When managing risk in traditional documents, it’s very difficult to manage the links between risks and their mitigations. And then every time a requirement changes or we identify new risks, it requires extensive manual review to understand the overall impact on our risk file and our product development lifecycle.
Missing the impact of those changes can also lead to unmitigated hazards that aren’t identified until much later in development, when it becomes much more difficult and costly to correct.
Dynamic Risk Management with Jama Connect
Pink: Jama Connect helps to solve this by allowing you to capture hazard analysis, calculate risk levels, and maintain Live Traceability™ from those hazards and their evaluations to mitigations and verifications, turning your risk file into a dynamic part of your development life cycle, sharing responsibility across the team, and giving you a live view of all the potential risks facing your product in real time.
Pink: Jama Connect’s preconfigured structure allows you to manage a global library of hazards and harms.
If we take a quick peek at my global library, you’ll see I’ve established a global harm and hazard library that I am sharing across all of the different projects that I’m working on. This allows us to standardize a list of common hazards and harms. Jama Connect does come preconfigured with the hazard list from ISO 14971. We can also manage our own, including setting things like the severity of harm and the probability of harm from a hazard that will then be standardized on every product that we’re working on.
Integrating Hazards into Product Development
Pink: As we switch to that product development project where I’m developing the CLEAR three hearing aid, we’ll see as I look into my risk analysis and evaluation component, the harms and hazards that I pulled in from my global library, and then the evaluations of those harms and hazards that I’m performing for this specific product.
We can evaluate each hazard for a specific sequence of events, capturing severity and probability levels here or inheriting those from those related hazards and harms, and ultimately calculating that initial risk level based on configurable lookup matrices and custom logic. This view feels very similar to working in the spreadsheet you might already be using today, but it helps to reduce human error based on globalized configuration for these calculations and deriving the severity and probability level.
Traceability of Risks to Mitigations
Pink: Once the risks are identified, they can also be traced to mitigations if we’ve determined that risk controls are required. So if we come up and enter the trace view, this will show me how each risk is associated to mitigating requirements or even external resources like the instructions for use that will tell the patient how to safely use this hearing aid without exceeding the recommended maximum volume.
Once we have these traces in place, they can also be traced even further down to the verification of these requirements so that we have the full scope of traceability showing the identification of the hazard, the evaluation and risk level, the mitigation with requirements and other resources, and the verification of effectiveness.
Pink: Once all of this is captured, we also can determine the mitigated probability level based on those new controls we’ve put in place, and the residual risk level has now been lowered.
Exporting Risk Reports
Pink: We can also export all of this out of Jama Connect using one of our out-of-the-box risk reports. This is lined with ISO 14971 will give us access to an Excel file here.
So now we can see, after we’ve exported that risk analysis trace, the full scope of hazard identification, pre-mitigation scoring and risk level, controls that we have put in place, and the post mitigation risk levels. We also have a benefit-risk analysis as applicable, and these reports are completely configurable to align with your existing process, your risk calculations, and all of the existing things you’re doing today in Excel, while maintaining a Live Traceability to those design inputs and design control processes that happen every day in Jama Connect. When you stop managing risk in disconnected spreadsheets, safety becomes an integrated part of your design process.
Conclusion and Further Resources
Pink: Thank you for watching this demonstration of risk management in Jama Connect. To learn more about optimizing your risk management process, visit our website at jamasoftware.com, specifically for our risk management package. And if you’re already a Jama Connect customer, your customer success manager or Jama software consultant can also provide additional insights. Thank you for watching.
Enabling Multi-Phase Reviews Across the Aerospace and Defense Systems Lifecycle
Reduce Manual Effort and Review Gaps in Multi-Phase Reviews with Automation
Aerospace & Defense engineering teams regularly collaborate to review and approve requirements, verify designs, and ensure critical documentation is approved before development progresses. But many programs require multiple sequential review phases to ensure information is properly developed, complete, and ready for release.
In this webinar recap, Patrick Knowles, Manager of Solutions, A&D at Jama Software, explores how teams can enable efficient, low-touch multi-phase reviews. You’ll learn how to combine workflows, automations, and review methodologies to prevent gaps, reduce manual effort, and bring clarity to complex review cycles.
What you’ll learn:
Why multi-phase reviews matter in high-assurance engineering programs
How to update item types and workflows to support automated, sequential approvals
Techniques track, display, and manage review status across teams
Approaches that reduce manual effort and ensure engineers work from officially released information
How Jama Connect® can help teams manage review cycles more efficiently
Equip your team with a scalable approach to managing reviews across the full product lifecycle.
THE VIDEO BELOW IS A PREVIEW OF THIS WEBINAR, WATCH THE ENTIRE PRESENTATION HERE
BELOW IS AN ABBREVIATED SECTION OF THIS TRANSCRIPT
Patrick Knowles: I’m excited to be here with you all and discuss something near and dear to my engineering heart. No matter what company, team, or project I’ve worked on, making sure information is reviewed effectively and ready for development has always been critical. This concept of multi-phase reviews within the system development lifecycle is a pertinent topic no matter where your team finds themselves within the lifecycle, whether it’s early on or late in the cycle. As we continue today, I really hope to illustrate practical examples as well as tangible solutions to this complex topic.
Our agenda today will cover the what, why, and how of multi-phase reviews. Additionally, I will demonstrate how user-friendly these reviews can be, as well as how accessible the data can be to users within a tool like Jama Connect. Our first topic will be centered around what a multi-phase review really is. We’re going to look at the definition. We’re going to look at some of the causality of it. We will then progress to understanding why these multi-phase reviews are both necessary and important, whether it’s standards and regulations requiring them or other reasons. This will then lead us into a discussion on how to implement them in Jama Connect and how that might improve all sorts of personas and people who operate within the tool, from engineering to program management, and improve their ability to simply understand where the data is in the design cycle. Finally, I’ll do a demonstration of the functionality live in the tool so we can truly see how effective this can be.
Knowles: But the first things first. What really is this concept of multi-phase review, and how does it differ from what we’ll call the norm or standard workflows and other processes? By definition, a multi-phase review is a series or set of reviews throughout the stages of a product’s lifecycle. These reviews are purpose-built to ensure that the data under review is effectively agreed to and approved by relevant stakeholders. The good news is we’re all super familiar with these multi-phase reviews, even though the term might be new. Nearly every engineering organization and every engineering review that exists leads to another review or is the gate to a new stage that includes more reviews. That, as a premise, is multi-phase reviews in a nutshell. This then can manifest itself into the most macro lifecycle approaches, like your system requirement review moving to preliminary design review and then onto critical design review, or even down into your more micro individual requirement approvals, and then there are associated verification closures after a verification or test event. Think something like a test readiness review, and then a closing review after the test is complete.
I want to discuss all of this in greater detail to ensure we are all on the same page before proceeding to explain why it is powerful and important to effectively manage these types of reviews. I want to narrow in on those two examples I’ve provided so far, the system requirements review and the preliminary design review, and so on, as well as the requirement and verification approach. Of course, there is the third example listed on the screen, and there are many, many more examples out there that bring up the core tenets of a multi-phase review.
The potentially most common example is that macro product lifecycle example, where you’re going from system requirement review and so on into another review. Engineers typically utilize this in one fashion or another, even if you don’t call it these different stages. Teams typically progress from system requirements review to a preliminary design review, and then to their all-important critical design review, which means you’re ready to cut metal, you’re ready to really get into that final stage of development. At each stage, engineers review requirements inside and out, but many times teams are unable to adequately display if each individual requirement or related artifact is approved at each of these stages on its own. This is just a little bit of foreshadowing for later in this conversation, where I explain the benefits of managing a multi-phase review or, in general, this multi-phase review approach. Standard reviews are siloed and individual, and they don’t follow some greater master plan, whereas a multi-phase review in this context will follow some greater plan where the data is always displayed, and users are always right at their fingertips, able to understand what’s going on.
Knowles: Additionally, teams may run into the multi-phase review approach when approving requirements just in general, where they likely will proceed through verification events and finally return to confirm that the requirement was adequately satisfied by the verification event. And there’s going to be a number of steps in there, from the requirement is approved to verification is approved to verification is live and being run and executed. And then finally, that last piece that I illustrated just a moment ago, where you approve that the verification itself met the needs of the requirement. Even if it was completed the way that the steps are written, you still need to validate and verify that it is truly meeting the needs. In scenarios like this, the phase might be spread out, but nonetheless, it is pertinent to the engineer designing the system that the requirement is approved. The verification expert and that verification needs to be completed, and they need to understand that, and they expect to be able to understand that. And then the system thinker who sees both the requirement and the verification, as well as the rest of the system, wants to see that all of that is coming together harmoniously to generate an effectively engineered product.
