Tag Archive for: Requirements & Requirements Management Page 10
Tag Archive for: Requirements & Requirements Management
Jama Connect® Features in Five: Change Management
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.
In this Features in Five session, Máté Hársing, Solutions Architect at Jama Software, explores the Change Management capabilities in Jama Connect, showing how regulated industries can streamline their compliance and efficiency across the product lifecycle.
VIDEO TRANSCRIPT
Máté Hársing: Hi, I’m Máté Hársing, Solutions Architect at Jama Software. Welcome to this Features in Five video on Change Management with Jama Connect. If you’ve ever worked in a regulated industry like MedTech, you know that change is inevitable, whether it’s from updated standards, customer feedback or internal improvements, where every change must be documented, assessed, and validated, because in our industry, changes can literally be life-critical. Without the right tools, managing change quickly turns into a mess, email threads, disconnected spreadsheets, and siloed tools. That leads to missed impacts, compliance risks, and wasted time.
Jama Connect helps bring order to that chaos with structured change management, and it doesn’t stop at development. After a product is approved, field feedback, manufacturing updates, or regulatory changes also need to be reviewed and connected to related items. Without a system in place, tracking those changes through email or spreadsheets risks letting things slip through the cracks.
So what goes wrong without Jama Connect? Teams can’t easily see what’s impacted by a change. Requirements, test cases, and risks live in separate tools. Manual versioning makes it hard to track who changed what and why. Unverified changes can lead to audit issues or delays. Here is how Jama Connect helps. During development, Live Traceability™, Versioning, and the Suspect Link tool help teams stay aligned and act fast. Impact Analysis and Version comparison give clarity before making a change. For released products, formal change requests pull in all affected items, and reviews in the review center bring visibility, collaboration, and confident decision-making.
Hársing: Here is a Trace View of our device’s system requirements. You can see everything it touches, subsystem requirement verifications, and associated risks. Now, we will simulate a change to this system requirement. Once the change is made, the suspect tool automatically flags impacted items downstream, letting us know that in this case, this particular version of the verification case no longer covers the updated requirement and has to be updated. This is what we call reactive change management. Switching to Impact Analysis, we can preview all linked items before implementing the change so our engineering and quality teams can assess the ripple effect and plan accordingly. This is known as proactive change management. It helps us assess the complete cost of a change across as many degrees of separation as our item’s traceability has, as well as providing filters to focus on specific domains, such as verifications in this case, drowning out the noise of any other items we don’t want to see for the time being.
Next, we will use the compare versions view to see what changed. Clearly marked, easy to digest, with intuitive red line/green line differentiation. This is especially helpful during design reviews or when responding to auditors. You’ll notice there is a comprehensive audit trail captured here, who changed what, when and why, so that we can create complete accountability in Jama Connect. And here’s how we handle the change to an approved product. We create a change request item, pull in related artifacts using an easily predefined filter, and send everything through a review. All stakeholders can review the changes in context, see the differences, and provide feedback, ensuring the change is well-documented and fully assessed. The change request can be finalized while we see all the related items and can make sure all the necessary changes in the scope of the change request have been implemented.
Hársing: Jama Connect supports seamless change management across the full product lifecycle, from controlled updates during development to formal change requests for approved products, ensuring traceability, visibility, and compliance every step of the way. Thank you for watching this demonstration of change management in Jama Connect. If you would like to learn more about how Jama Connect can optimize your product development processes, please visit our website at jamasoftware.com.
Expert Perspectives: The Shift Towards Systems Engineering in the Architecture, Engineering, and Construction (AEC) Industry
Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields.
Robust requirements management in the construction industry, enabling teams to better meet client needs, comply with regulatory standards, and deliver projects efficiently
The adoption of systems engineering in construction projects
The challenges faced in implementing these methodologies, and how major companies are adapting to this change
Kenzie Ingram: Welcome to our Expert Perspectives series where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future in their fields. I’m Kenzie, your host, and today I’m excited to welcome Burzin Tampal, a well-respected Senior Requirements Manager from Toronto, Canada with more than 10 years of experience in systems engineering.
Burzin has worked on major projects within infrastructure, energy, and mining markets across all phases of the project lifecycle. He specializes in developing and implementing processes for requirements management, verification and validation, and interface management on complex projects. Joining Burzin is Jama Software’s own Joe Gould, a seasoned Senior Account Executive with extensive experience in sales within the architecture, engineering, and construction industry. Today, Burzin and Joe will be speaking with us about the shift towards systems engineering in the architecture, engineering, and construction (AEC) industry. Without further ado, I’d like to welcome Burzin Tampal and Joe Gould.
Joe Gould: Hello, everyone. I’m Joe Gould, Senior Account Executive with Jama Software, and welcome to today’s interview with an expert. I’m thrilled to have Burzin Tampal with us, a seasoned expert in systems engineering. Today, Burzin will be sharing insights into the challenges and benefits of adopting a systems-focused approach in the AEC industry. Burzin, thank you for joining us. It’s a pleasure to have you here.
Burzin Tampal: Thank you, Joe. I’m honored to be here.
Gould: Great. Well, Burzin, let’s jump right in. Can you describe your journey and what prompted the shift towards adopting systems engineering in construction projects?
Tampal: Certainly. So I’ve had the opportunity to work in the medical, financial, and software development sectors prior to working on major projects in the AEC where I initially started off in the rail and transit division. Unfortunately, not all projects were successful by project management standards and most ended either over budget, over schedule, or had quality issues. These projects would sometimes lead to lawsuits, and I had heard that this was somewhat typical for these projects.
I was quite concerned that this was status quo for a 200 plus year old industry, so I started doing some independent research and went down a path which led me to learning more about systems engineering. I came across a popular study. You might know or heard of it. It’s the 2015 Chaos Report by The Standish Group. And although it was not specific to the rail and transit industry, I felt it was very applicable.
If my memory serves me correctly, the outcome stated that something like the top three, the top five reasons, rather, for failed projects was related to poor requirements management practices. I guess I really tried to right the ship after that. I could start to see where the current practices on these major engineering and construction projects were failing to meet the needs of the complex project.
And after gaining some modest successes, I was determined to rethink how we implement systems engineering best practices efficiently across all engineering and construction projects. I developed my own strategy for deploying a lean systems engineering solution on projects, and I’ve been using systems engineering principles on all construction projects ever since.
Gould: That’s great. It’s fascinating to hear how your organization’s moved towards systems engineering. I know that shift can often come with its own set of challenges, but I’d love to see this thought leadership in our industry, Burzin. Next question, can you explain how requirements management plays a role in your construction projects?
Tampal: Absolutely. So requirements management, as most people think about it, has typically been used on systems projects, which inherently have a lot of complexity. If we take a step back, however, without getting into details about a rigorous process or beneficial tools, requirements management at its core is simply meant to track and trace stakeholder needs and project requirements throughout the project lifecycle with the end goal of ensuring compliance and satisfying the stakeholder needs.
Now, I can’t think of a project, systems or not, which wouldn’t benefit from the practice with that definition. One that is meant to ensure that the handed over project meets the needs of the client as formally agreed to. So with that in mind, requirements management really forms the backbone of systems engineering and even project management to a certain degree on engineering and construction projects that I’ve been working on.
Gould: Yeah, it sounds like requirements management really sounds like a crucial aspect here, Burzin. I imagine keeping track of requirements in a way that aligns all stakeholders can make an absolute huge difference.
Tampal: Absolutely. 100%. That’s fundamental.
Gould: So tell me what benefits you’ve experienced moving to a more systems engineering focused approach.
Tampal: Well, where do I start? There are many obvious benefits of using systems engineering that you could read about in a lot of systems engineering materials. The INCOSE Handbook is a great resource. But I think I’ll expand on some of the benefits that are not typically highlighted. So the first benefit I would mention is consistency. Leveraging a standard systems engineering process enabled consistent outputs and deliverables.
While this may sound underwhelming, it was actually the foundation for many of the other benefits we were able to attain. Some other more common benefits include a reduction in error quality issues, which meant reduced corrective effort, improved communication, which resulted in reduced duplication of effort. And once the processes were standardized and we were getting consistent outcomes, we could then implement process efficiencies which resulted in reduced resources or effort required to perform the work.
Gould: Wow, that’s excellent. It’s great to hear that you’ve realized those tangible benefits. Sometimes there are those moments where new processes open up even more possibilities.
Gould: So what are some of the unique challenges construction projects face compared to say traditional industries like automotive or aerospace when it comes to implementing systems engineering, Burzin?
Tampal: That’s a great question. There are a lot of unique challenges. So conceptually, systems engineering best practices involve the requirements development process to be performed collaboratively with all stakeholders participating in the creation, review, and approval of the project requirements set. Traditional industries specializing in manufacturing and product development such as the automotive industry benefit from the ability to own their requirements management process from inception.
Most major architecture, engineering, and construction or AEC projects, however, are managed based on project requirement input documents and schematics in PDF, especially in the public sector. While it might not seem like much of a challenge at first, the fact that the initial baseline of project requirements is provided in a PDF document requires a great deal of upfront effort to review, extract, and manage project requirements.
Additional challenges include the fact that request for proposal (RFP) and contract documents are typically created by multiple people or teams in silos from each other over a long period of time. This practice tends to lead to incomplete requirements causing scope gaps, duplicate requirements causing duplicate effort, and even conflicting requirements causing quality issues across the project requirements set.
A final legal review of those requirements and edit of those documents typically compounds the challenges by adding a layer of ambiguity to the requirements set. Furthermore, different contract models and strategies come with their own unique set of challenges, almost always impacting efficiency of requirements change management.
Gould: I think I’ve been through some of those PDF reviews before, Burzin, so that makes a lot of sense. Construction does seem to have a unique constraints compared to industries like automotive or aerospace. Can you talk a little bit about the challenges of keeping everyone in sync and aligned on a complex project?
Tampal: Absolutely. It’s commonly known that communication is key. This is even more so true when it comes to large projects where there’s a complex stakeholder relationship structure involving a mix of clients, contractors, suppliers, sub-consultants, vendors, and third parties. Ensuring that you are providing the most up-to-date information to the correct stakeholders is certainly a challenge.
Since construction projects can range in duration from weeks to years and even decades, key things to consider include the frequency, mode, and the level of detail in communications. Ensuring everyone is aligned and contributing towards the next major milestone involves meticulous planning and consistent monitoring and execution.
Gould: So Burzin, staying aligned on a complex project has to be a major priority for everyone, especially with so many moving parts in construction projects.
Tampal: Absolutely. At times there can be up to a hundred or more stakeholders that you have to manage and keep informed.
Gould: That’s a lot of alignment. Definitely a lot of alignment. So Burzin, how do you handle the integration of evolving project requirements throughout the construction process? I mean, what best practices do you follow to manage changes without disrupting progress?
Tampal: Well, this is certainly a challenge on all projects and more so on large complex AEC projects. We all know the inverse relation graphic of cost of changes over time on a project and the opportunity to influence or make a change on a project where there is more opportunity and lower cost to implement a change early on in the project life cycle and much less opportunity and higher cost to implement a change later in the project life cycle.
Without an industry-recognized requirement software tool like Jama Connect®, it would nearly be impossible to identify the changes, perform an impact assessment, review the changes with the change control board for approval, and then implement all the approved changes, ensuring all impacted requirements and other items are resolved as required. Because changes during construction are typically more costly, we want to ensure that the project is adhering to a well-defined configuration management and change control process.
Some of the best practices that we implement include using a functional tool to track the proposed changes, trace the changes to all impacted items, this could be evidences or other requirements, include all relevant stakeholders in the CCB or Change Control Board when reviewing and deciding to approve a change, and adequately communicating the approved change to teams for all impacted items. Although this will not eliminate disruption, this will greatly reduce the potential of negatively impacting the project’s quality, schedule, or budget.
Gould: Wow. It sounds like balancing evolving requirements with project stability is no small feat, especially in a field as dynamic as construction. I’m sure your approach to managing this balance is a key factor in keeping your projects on track despite the inevitable changes.
Tampal: Absolutely.
Gould: So Burzin, what role does technology such as software tools for requirements management play in the shift towards systems engineering, do you think?
Tampal: Well, throughout this interview, I’ve mentioned many challenges which come with the territory when participating in construction projects, particularly large and complex AEC projects. Technology such as software tools for requirements management play an integral role in the shift towards deploying a standards-based systems engineering solution in line with industry best practices.
The technology shift has contributed to both increasing the complexity on projects as well as providing software tools that can better calculate, simulate, and manage the solution. Projects have already shifted to digital delivery, and leveraging the best tool fit for purpose is detrimental to project success.
When used correctly, requirements management tools such as Jama Connect, design management software such as AutoCAD, MBSE tools for modeling, and construction management software such as Autodesk Construction Cloud or ACC can significantly reduce the effort required to produce a deliverable while improving the quality at the same time. However, with the available software tools in the market, it is becoming increasingly more important to ensure the tools can integrate with each other and establish a digital threat,d and streamline the overall process.
Over the past two years, there have been a boom in artificial intelligence and machine learning. We are now in a time where data is the most valuable currency, and therefore, understanding how to get the most out of the technology and software solution deployed on a project is detrimental to long-term success.
Gould: I couldn’t agree more. It sounds like technology really supports teams in navigating the complexities of systems engineering. I can imagine that certain features in requirements management tools make a significant impact on how effectively you implement this approach.
Tampal: Absolutely.
Gould: Well, Burzin, I think we’re out of time. I want to thank you so much for sharing your insights and your experiences with us today. It’s been for me incredibly valuable to hear about your journey in integrating systems engineering. We appreciate your time and openness and look forward to seeing the continued success of your projects. Burzin, thank you again.
Tampal: Thank you for having me, Joe. Appreciate it.
Ingram: Thank you for joining us in this episode of our Expert Perspectives series. We hope you’ve enjoyed this conversation between Burzin Tampal and Joe Gould on systems engineering and architecture engineering in construction industries. If you’re an existing customer and want to learn more about Jama Software, please reach out to your customer success manager or consultant.
If you’re not yet a client, please visit our website at JamaSoftware.com to learn more about us and how we can help optimize your development processes. Thank you and stay tuned for our upcoming episodes of Expert Perspectives. Please note that the views expressed in the interviews and commentary are solely those of the individuals providing them and do not reflect the opinions of Jama Software.
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[Webinar Recap] Empowering Complex Development with Responsible AI
AI is reshaping the way teams manage complexity in product development — but in regulated industries like aerospace, defense, automotive, and medical devices, responsible AI adoption is critical.
In this webinar, our expert Katie Huckett will explore how AI is transforming modern development processes, the ethical considerations of AI adoption, and the latest AI-driven innovations in Jama Connect®.
What You’ll Learn:
How AI is streamlining requirements management with automation and predictive insights
Best practices for responsible AI adoption in compliance-heavy industries
Jama Connect’s AI-powered features that enhance requirements quality, traceability, and risk mitigation
Our Amazon Web Services (AWS) partnership and how it enables secure, scalable AI-driven workflows
Below is an abbreviated transcript of our webinar.
Katie Huckett: Welcome everyone. Thank you for joining us today for this exciting webinar. Empowering Complex Development with Responsible AI. In today’s rapidly evolving world, industries like aerospace, defense, automotive, medical devices and financial services are facing unprecedented challenges. As products and systems become increasingly complex, ensuring regulatory compliance requirement clarity, and test coverage has never been more critical. Artificial intelligence is transforming the way we approach these challenges, offering powerful tools to automate tedious processes, enhance decision-making and improve requirement quality. But with AI’s potential comes a responsibility to ensure fairness, transparency, security, and compliance.
By the end of this session, you’ll gain a deeper understanding of how AI can accelerate development while maintaining accuracy, compliance, and ethical integrity. I’ll be your speaker today. My name is Katie Huckett. I bring over 15 years of product management experience and enterprise solutions. I’m one of Jama Software’s senior product managers, where I play a key role in bringing Jama Connect Advisor™ to life, as well as our AI strategy and roadmap for the future evolution of our AI offerings. In this webinar, we’ll explore the role of AI and complex product development in regulated industries. What is responsible AI and how is it used? Our partnership with Amazon Web Services, including our commitment to AI governance and security, ensuring AI aligns with industry standards and best practices.
Jama Connect’s AI-driven innovations leveraging AWS AI tools and discuss how AI enhances traceability, compliance verification, and validation while keeping human expertise in control. We’ll have a brief question and answer portion before we conclude today. Let’s dive in. Starting with Jama Software and our role in the product development ecosystem. Our vision and our purpose is to make sure that innovators can efficiently achieve success, and as you’ll see from today’s discussion, that’s really at the core of what drove our introduction for Jama Connect Advisor. From a broader solution standpoint, Jama is the number one requirements management provider in the marketplace.
We help teams with requirements management and product development through live traceability that also spans not only requirements, but the validation and verification components on the test side, risk management, and other key data that drives those processes forward. The value that we hope these innovative organizations or customers derive is really focused around things like cycle time reduction, helping speed time to market, enabling through live traceability, the ability to gain visibility and control over the organization’s product development processes, and really drive a tremendous amount of value and ultimately ensure compliance and risk management.
Huckett: As far as organizations that we work with, we span medical device, automotive, industrial machinery, software. This is just a sampling of customers that we have the pleasure to partner with. We have over 800 customers globally. These organizations span from smaller startup companies to large global enterprises. So with that very short intro to Jama Software, I would now like to review some of the complexity and challenges that we see today in product development and of course to introduce you to Jama Connect Advisor. Today’s systems have become much more complex and the emergence of the system of systems architecture has become the dominant approach for devices in all sectors, whether it’s aerospace, automotive, medical, and even consumer products.
The system of systems is actually a collection of independent subsystems that are integrated into larger systems and deliver the unique capabilities required by users. The challenges that is difficult to predict accurate, predictable models of all emergent behaviors. So Google’s systems of systems performance is difficult to design. That leads to testing and verification verifying upgrades to existing systems of systems is difficult and expensive as well, which is hard to scale. These are some of the factors that led us to think about how we can help. In today’s landscape, complex product and software development and manufacturing require organizations to balance innovation, compliance, and efficiency.
Industries today face increasing regulatory scrutiny, rising product complexity, and pressure to accelerate time to market. Let’s take a look at the role of AI in modern requirements’ management. Modern products are no longer purely mechanical. They integrate hardware, software, AI, and cybersecurity. For an example, a self-driving car must integrate advanced driver assistance systems, cloud connectivity, AI-powered decision-making, and functional safety. AI-driven requirement validation ensures that specifications are complete, testable, and free from ambiguities, preventing integration failures later. There’s also regulatory pressures and compliance challenges.
Industries such as aerospace, medical device, automotive, again, must comply with strict safety and cybersecurity standards. AI can map requirements to relevant regulations, ensuring compliance is automated and continuously monitored. There’s also a push for faster development cycles. Traditional product life cycles are shrinking due to market competition and innovative demands. AI-powered predictive impact analysis helps developers understand the effects of changes instantly reducing rework and speeding up time to market. There’s also a huge burden of manual processes. Many organizations still rely on spreadsheets, disconnected documents, and siloed teams to manage requirements.
AI-powered natural language processing can automatically detect inconsistencies, duplications, and incomplete requirements, improving efficiency. As well as a large need for better communication, collaboration, and visibility. So as teams become more distributed, cross-functional collaboration is more difficult. AI-powered requirement linking and automated traceability ensure that all stakeholders have real-time insights into requirement changes. AI is transforming requirements management by automating manual error-prone processes such as automatic requirement classification. AI can analyze text and categorize requirements by priority, risk, or compliance relevance.
Huckett: There’s also duplicate and conflict detection. AI can identify duplicate or conflicting requirements, reducing errors. There’s also a need for enhancing accuracy and requirements traceability, so AI can help ensure that every requirement is properly linked to tests, regulations, and design components, reducing compliance risk. We also have improved decision-making through predictive analytics. AI enables teams to make data-driven decisions faster and with more confidence. As product complexity increases, traditional requirement management cannot scale effectively. AI-driven tools and Jama Connect will automate compliance, enhance traceability, and improve decision-making, helping industries stay ahead of regulatory and market demands.
AI is not replacing engineers, it is augmenting their capabilities, enabling teams to develop safer, more compliant, and more innovative products faster. The rapid adoption of AI-driven tools in highly regulated industries brings immense opportunities for efficiency, automation, and innovation. However, AI also introduces ethical regulatory and governance challenges that must be addressed to ensure fairness, compliance, and trustworthiness in AI-driven decision-making. This section will explore the principles of responsible AI, regulatory hurdles, best practices for governance, and real-world examples of AI successes and failures.
As AI systems increasingly influence safety-critical industries, organizations must ensure their AI solutions adhere to ethical AI practices to prevent bias, misinformation, and harm. Responsible AI encompasses the following core principles. Fairness, which is your AI models must be free from bias to ensure equitable outcomes. Transparency, AI decision-making should be explainable and understandable. Accountability, organizations must take responsibility for AI-driven decisions. And of course, privacy and security, AI systems must protect sensitive data and prevent misuse.
AI is used in mission-critical applications such as aerospace and defense, where we have autonomous drones and AI assistance surveillance. In automotive, we have AI-powered advanced driver assistance systems, and in medical devices we have AI-driven diagnostics and robotic surgery. If AI models are not carefully designed, tested, and governed, unintended biases, errors, or security vulnerabilities could lead to catastrophic consequences. Not to mention the complexity of navigating regulations in a variety of industries. So for example, in aerospace and defense, AI and avionics and defense systems must comply with several standards.
Medical devices, we have the FDA Good Machine Learning Practices sets guidelines for AI-driven medical software. And in the automotive industry, AI in autonomous vehicles must meet ISO 21448 and ISO 26262. AI relies on large data sets, often containing sensitive information. Organizations must ensure compliance with regulations such as GDPR, which protects EU citizens data from misuse. There’s HIPAA, which governs healthcare AI solutions in the US and the California Consumer Privacy Act, which regulates AI handling consumer data. To build trustworthy and responsible AI organizations need robust governance frameworks that ensure AI models remain fair, explainable, and compliant over time.
Organizations should implement structured AI governance frameworks such as NIST AI Risk Management Framework, which provides a structured approach for assessing AI risks. In the way of the ISO/IEC 42001, which is an AI management systems standards, which establishes best practices for AI governance. We also have the IEEE Ethically Aligned Design, which focuses on human-centric AI development. For example, a medical device manufacturer developing an AI-powered diagnostic tool can use the NIST AI Risk Management Framework to ensure the model’s explainability, fairness, and reliability.
Huckett: AI models degrade over time as real-world conditions change, so organizations must continuously monitor AI performance for bias and drift, gather feedback from domain experts, users, and regulatory bodies, and implement AI auditing mechanisms to detect unintended outcomes. Let’s talk about a few real-world examples. So we have here a couple of case studies of successful AI adoption. So AI-assisted radiology tools have improved early cancer detection by 30% leading to better patient outcomes. One of the key factors in the success was the AI models were trained on large diverse datasets and continuously validated by human radiologists.
Another example, AI-driven predictive maintenance in commercial aircraft has reduced downtime by 25%, saving airlines millions in operational costs. One of their key factors for success was AI predictions were cross-validated with human engineering teams before implementation. And here we have a few real-world examples that are really cautionary tales in AI adoption. In 2018, an AI-driven hiring system was found to be biased against female candidates because it had been trained primarily on resumes for male applicants. So the lesson learned here is that AI models inherit bias from historical data emphasizing the need for bias audits and fairness checks.
And several self-driving car crashes occurred due to AI, misidentifying obstacles, pedestrians, or unexpected road conditions. So their lesson learned is that AI models require continuous real-world testing and human oversight to handle edge cases effectively. By proactively managing AI risks, organizations can unlock AI’s full potential while ensuring safety, fairness, and compliance in their industries. At Jama Software, we are committed to delivering responsible, scalable, and secure AI solutions to help our customers manage complexity in highly regulated industries. By partnering with AWS, we ensure that AI and Jama Connect is secure, responsible, and purpose-built for the industries we serve.
Enhancing efficiency without compromising compliance. AWS is at the forefront of AI and machine learning innovation, offering scalable, secure, and cutting-edge AI solutions that power businesses across many different industries. With industry-leading AI services, AWS enables organizations to automate complex tasks, extract insights from data and enhance decision-making with state-of-the-art machine learning models. From natural language processing to generative AI and predictive analytics, AWS provides flexible enterprise-grade AI tools that drive efficiency, improve accuracy, and accelerate product development, all while ensuring security, compliance, and responsible AI governance.
By leveraging AWS AI, companies can turn vast amounts of data into actionable intelligence, unlocking new possibilities for innovation and transforming the way they work. AWS’s AI and machine learning solutions are designed to scale effortlessly with business needs, supporting everything from small AI experiments to large enterprise applications. AWS AI services comply with industry-specific security standards, including HIPAA for healthcare applications, GDPR and CCPA for data privacy, ISO 27001, SOC 2, and FedRAMP for cloud security and governance. Amazon Web Services is deeply committed to the responsible development and deployment of artificial intelligence.
Functional Safety in Industrial Manufacturing: Navigating IEC 61508, ISO 13849, IEC 10218 for Safer, Smarter Operations
In the dynamic world of industrial manufacturing, the stakes have never been higher. As factories grow smarter and more interconnected, ensuring the safety of workers, equipment, and processes is paramount. Functional safety, a concept grounded in preventing and mitigating risks through system design and operational safeguards, has become a cornerstone of modern industrial practices.
This eBook serves as your comprehensive guide to navigating the complex but essential landscape of functional safety standards. From the foundational principles of IEC 61508 to the robotic-focused provisions of ISO 10218, we will delve into the key frameworks that underpin safer, smarter operations.
Whether you’re an engineer, safety professional, or business leader, understanding these standards is not just about compliance — it’s about future-proofing your operations in an era of rapid technological advancement. Let’s explore how to harness the power of functional safety for a more resilient and innovative manufacturing environment.
What is Functional Safety? Functional safety ensures that industrial systems operate safely even when they fail. It encompasses risk assessment, hazard mitigation, and the implementation of controls that reduce risks to acceptable levels. Unlike general safety measures, functional safety directly addresses equipment malfunctions and system failures.
Why is Functional Safety Critical?
Protecting Lives and Assets: Reduces the likelihood of accidents, injuries, and damage.
Ensuring Compliance: Meets legal and regulatory requirements for industrial operations.
Boosting Operational Efficiency: Reduces downtime by preventing catastrophic failures
Real-World Examples
The importance of functional safety becomes evident through real-world scenarios where its absence or presence has significantly impacted outcomes. Below are several real-life examples that have been generalized for educational purposes:
Chemical Processing Plant: A chemical manufacturer experienced a significant incident due to the failure of a pressure control system. The lack of redundancy and inadequate safety measures led to a dangerous overpressure scenario, causing equipment damage and a toxic gas release. This incident underscored the need for comprehensive risk assessments and safety instrumented systems (SIS) compliant with functional safety standards.
Improvement Through Functional Safety: Another plant, learning from such failures, implemented an SIS aligned with IEC 61508 standards. By incorporating redundancy in pressure sensors and automated shut-off valves, they successfully mitigated similar risks, resulting in zero incidents over a five-year period.
Automotive Industry: A global automotive manufacturer faced challenges in ensuring brake system reliability. Initial designs lacked sufficient fault-tolerant measures, which could have led to brake failure under specific conditions. Applying functional safety principles, the company developed a braking system that met SIL 3 requirements, enhancing reliability and customer trust.
Food Processing Machinery: A food processing company faced frequent machine shutdowns due to sensor malfunctions. This not only disrupted production but also posed safety risks to operators. By redesigning their systems to comply with ISO 13849 and implementing real-time diagnostics, the company reduced unplanned downtime by 40% and improved operator safety.
Renewable Energy Sector: A wind turbine operator encountered significant downtime due to control system errors. By adopting functional safety standards, they redesigned their turbine control systems to include failsafe mechanisms and predictive maintenance features, minimizing operational disruptions and ensuring safer energy production.
These examples illustrate how functional safety principles, when applied effectively, can prevent accidents, enhance reliability, and improve operational efficiency across diverse industries.
IEC 61508 is the umbrella standard for functional safety, applicable across industries. It provides comprehensive guidelines for designing, implementing, and maintaining safety-related systems. This standard is particularly valuable for manufacturers dealing with complex systems that demand a high level of safety integrity.
Key Concepts
Safety Integrity Levels (SIL): These levels define the required risk reduction for safety functions, guiding system designers in their choice of components and processes.
System Lifecycle Approach: A holistic framework that considers safety at every stage, from concept to decommissioning.
Risk Reduction: This involves combining advanced technology, rigorous processes, and human expertise to address potential hazards.
Practical Application
Manufacturers can integrate IEC 61508 to design fail-safe systems that detect, prevent, or mitigate failures before they escalate. For instance, in process industries like oil and gas, SIL assessments ensure that critical safety functions meet stringent reliability requirements.
IEC 61508 provides a structured approach for designing safety-related systems, ensuring they meet rigorous reliability and risk-reduction criteria. In industries like oil and gas, this standard is applied to Safety Instrumented Systems (SIS) that monitor and control critical processes. For instance, pressure sensors integrated into pipelines detect potential overpressure conditions. When thresholds are breached, the SIS activates emergency shutdown valves to isolate affected sections, preventing catastrophic equipment failures or environmental hazards. The standard’s lifecycle model ensures these systems are developed, tested, and maintained systematically, reducing the likelihood of failures during operation.
Another practical application is in renewable energy, where wind turbine control systems must operate reliably under varying conditions. By adhering to IEC 61508, manufacturers can incorporate fault-tolerant designs, such as redundant control modules and predictive maintenance algorithms. These enhancements ensure that turbines continue to function safely even when a component fails, maximizing energy production and operator safety. The standard’s emphasis on traceability and verification provides confidence that safety requirements are met throughout the system’s lifecycle, making it a cornerstone for functional safety across diverse industrial settings.
Real-World Applications
One notable example of IEC 61508 implementation is in the chemical processing industry, where automated safety instrumented systems (SIS) are crucial. These systems monitor critical parameters, such as pressure and temperature, and activate protective actions when thresholds are exceeded. For example, a major oil refinery implemented an SIS compliant with SIL 3 to prevent catastrophic equipment failure. The system included redundant pressure sensors and automated valve shutdown mechanisms, effectively reducing the risk of explosion.
Similarly, the automotive industry leverages IEC 61508 for the development of electronic control units (ECUs). A global automotive manufacturer used the standard to design braking systems that maintain performance even during sensor or actuator failures. By adhering to the lifecycle approach outlined in IEC 61508, the company ensured high reliability while minimizing development costs through early risk identification.
These cases highlight the adaptability of IEC 61508 across various sectors, demonstrating its value in achieving both safety and operational excellence.
This standard focuses on the functional safety of machinery, specifically the design and validation of safety-related parts of control systems (SRP/CS). It is essential for environments where machinery interacts closely with operators, ensuring that even complex systems remain safe.
Performance Levels (PL) vs. SIL
While Safety Integrity Levels (SIL) measure risk reduction across systems, Performance Levels (PL) evaluate the probability of dangerous failures in machinery control systems. ISO 13849’s PL framework is particularly relevant for addressing mechanical hazards in automated production lines.
Ensuring Compliance To comply with ISO 13849, manufacturers must:
Identify potential hazards in machinery.
Design control systems with adequate fault tolerance.
Conduct thorough validation and testing.
In industries like automotive or food processing, where machinery operates at high speeds, ISO 13849 provides the tools to ensure both productivity and operator safety.
IEC 62061 – Functional Safety for Machinery Systems
Overview IEC 62061 builds on IEC 61508 and ISO 13849, offering a structured approach to machinery system safety. It provides a detailed methodology for assessing risks, setting safety requirements, and validating safety-related systems.
Integrating Safety
By adopting IEC 62061, manufacturers can:
Transition seamlessly between PL metrics and SIL frameworks, ensuring consistency across systems.
Develop comprehensive safety lifecycle plans that align with operational goals.
Optimize machinery designs for reliability and compliance.
Key Benefits
IEC 62061 emphasizes adaptability, allowing manufacturers to apply its principles to diverse machinery systems. For example, in semiconductor manufacturing, it ensures that high-precision equipment operates reliably under strict safety protocols.
[Webinar Recap] Navigating AI Safety with ISO 8800: Requirements Management Best Practices
As artificial intelligence (AI) becomes increasingly embedded in automotive and semiconductor applications, ensuring its safety is critical.
In this webinar recap, Matt Mickle from Jama Software and Jody Nelson from SecuRESafe (SRES) dive into the newly introduced ISO/PAS 8800 provides a framework for managing AI-related safety requirements in road vehicles, addressing the challenges of functional safety, system reliability, and risk mitigation.
What You’ll Learn:
The importance and framework of ISO/PAS 8800 for AI safety in road vehicles
How to derive and manage AI safety requirements effectively
Addressing insufficiencies in AI systems and ensuring traceability to related standards
Practical strategies for integrating ISO 8800 into a structured requirements and systems engineering workflow
Below is an abbreviated transcript of our webinar.
Jody Nelson: Appreciate the invitation from Jama Software for this discussion. I think it’s a very important topic as we’re going to be talking about a newly released standard, the ISO/PAS 8800. And our agenda for today, we’re going to first start out and talk about the framework and importance of the 8800. In order to do this, we have to pull in other standards. So as we’ll discuss in this discussion, the 8800 is not a standalone standard. It does have dependencies on ISO 26262 and ISO 21448. So we’ll start out from some framework for ADAS, automated drive systems, and then we’ll go into deriving and managing AI safety requirements. And this is a very difficult topic to go through. So this is where it is really great in this partnership with Jama Software to walk through it with a requirements management tool because it’s much easier to see once we’re in a tool environment.
And we’ll talk about addressing insufficiencies. This is something that we talk about a lot in Safety of Intended Functionality (SOTIF.) Now, we’re going to drive that down into lower levels into the AI system, including down to the machine learning model level. And with all of these safety standards that we talk about and with all these aspects of safety, we need traceability. So we’ll talk about in 26262 traceability between requirements to verification testing to your safety analysis. And these are the aspects that we want to show in today’s webinar. And then we’ll actually jump into the tool itself and show you a practical example of how to use 8800 and just show that flow.
So before we get into that, I do want to lay out a little bit of an AI requirements landscape. And before we jump into the AI safety landscape, let’s take a step back because it’s very important that we harmonize and ground ourselves with where we’re at now prior to these AI safety standards.
Well, the Automotive Functional Safety Development, as most of you know, the ISO 26262, was released in November of 2011. We have this pyramid of development. And it’s very common, and one of the biggest advantages of 26262 is almost everything’s built into the standard. So we don’t look out of the standard much when we’re in the traditional functional safety world. It’s all built into the standard.
Well, we start out with this quality management system (QMS) layer, this quality management system layer, and that’s the one exception to that last statement. This is where we point out to an outside standard such as ISO 9001, IATF 16949. These are the most commonly used in automotive, and that sets up our basis for our quality management layer. So that’s setting the initial processes.
Nelson: But that’s not sufficient enough for safety. So we build on top of that functional safety processes, functional safety policies, which we call our functional safety management. And the majority of that is captured in Part 2 of the standard ISO 26262. So that’s the layer that we build on top of the QMS.
And then of course, we need a path forward. We need an understanding of the steps that we need to follow, and this is within our functional safety lifecycle. Again, this is built within the standard. We can jump into Part 2 of ISO 26262. It provides us an overall life cycle from concept phase all the way to decommissioning. So we’re talking about 15, 20-year lifetime.
And then on top of that is where we do the actual development, and that’s where in the standard’s Parts 3 through 7 goes into the concept phase, driving functional safety requirements, technical safety requirements, driving down into your hardware and software, and then coming back up to this V cycle where we do verification and eventually validation.
Now, this framework is well established. As I mentioned, since 2011, we’ve been following ISO 26262, and nearly the entire framework is built in. As we transition into autonomous drive and to AI safety, it gets a little bit less clear and less straightforward as this. So I readapted that first pyramid and looked at now the AI safety aspects of our development in automotive.
So in the bottom layer, we’re going to have to have an AI management system. So we’re still going to use our 16949 or 9001 QMS, but we need to extend beyond that. And what was released in 2023, late in 2023, is a standard called ISO/IEC 42001, which I’ll discuss briefly today. This sets up the nuances that we need to consider when we’re talking about AI, data governance, ethical concerns. All these kinds of responsible AI aspects are included into this framework of the 42001. 42001 is not meant to replace 16949. It’s meant to play with it to work together with your QMS. So it’s not about getting rid of your QMS processes. It’s about adding in the inclusions for our concerns or relevance with AI.
Well, just as we had in functional safety, we have to build in an AI safety management on top of that. Now, we’re going to start pulling in, for example, ISO/PAS 8800 that we’ll be talking about today, but in conjunction with the 26262 because 26262 still helps us establish the safety management. 8800 gives us the specific aspects of AI to that.
Nelson: And then our lifecycle, we will be following aspects of 26262 lifecycle, but also SOTIF. So the ISO 21448 will be a critical aspect as well because we’re going to be combining both of these ideas into what will lead into the aspects that we need for the ISO 8800. So all three of those will be incorporated to build in this AI safety lifecycle.
Then of course, for the AI safety development, we’re going to have aspects of 26262. We’re going to have aspects of SOTIF, 8800 as we discussed today. And then we have some kind of complementary standards that will help us round this out. The ISO/IEC 5469, this will be replaced by an actual technical standard in the future. But as of now, this is a technical report. It is informal so it provides us only guidance that there’s no shells or requirements in it, but it’s going to help us. And we’ll see in the 8800 as you go through the standard, it points out to 5469 in some cases. And then soon to be released or currently released, the ISO 5083, which will be a replacement to the ISO 4804. This will help again align to ISO 26262 to that V cycle, that V-Model that we’re commonly used in 26262 world. But help us with more of the verification, validation activities in autonomous drive.
So I called this the new automotive model. As I mentioned before, we do have to point out to a few other standards. I do understand there is in some cases standards fatigue. We’re trying to boil this down into the most condensed version that we can present here.
So just briefly, I’ll look into a couple of these standards. As I mentioned ISO/IEC 42001, if you’re not familiar with this, it was released late in December of 2023. It is agnostic to industry, it’s agnostic to size of company, and it’s for both organizations that use AI or that develop AI. So it’s a very broad standard. Again, it is our QMS layer, but with the specific aspects of AI that we need to talk about. So it helps us ensure this responsible development of using AI systems. It does address ethical considerations, transparency, safety, and security, and it does provide a risk-based approach. Most of our functional safety standards and safety standards that we talk about in automotive are a risk-based approach. So within 42001, we talk about risk analysis, risk assessments, risk treatment, how we’re going to control these risks, and then an impact assessment of the overall risks that remain. So that’s our bottom layer.
And then I just wanted to point out the ISO/IEC 5469. Again, this is informative, meaning there’s no shells in the standard or in the technical report. It just provides us guidance and draws in this connection between functional safety and using AI systems either as a safety mechanism or somehow the AI system can impact safety.
The Clear Choice: Why Jama Connect® Surpasses Codebeamer for Requirements Management and End-to-End Traceability
To adapt to increasing industry challenges and complexities, innovative organizations are now requiring best-in-class software to scale development, reduce risk, save time, and ensure compliance to quality, safety, and security regulations.
As organizations strive to deliver innovative products while navigating regulatory requirements, the tools they use for requirements management and traceability can make or break their success. This eBook is designed to help you understand the critical differences between Jama Connect and Codebeamer, two leading requirements management solutions, so you can make an informed decision.
The Requirements Sector
The landscape of requirements management has undergone significant transformation. Traditional tools (like IBM® DOORS®) which once dominated the market, are now considered outdated. These legacy systems often lack the flexibility, ease of use, and integration capabilities required by modern teams. As a result, organizations are turning to modern solutions like Jama Connect that are built to meet the needs of today’s dynamic development environments.
Why Jama Connect?
Jama Connect stands out as a leading requirements management solution because it is designed with the user in mind. Its modern, user-friendly interface, combined with powerful features like comprehensive traceability and real-time collaboration, ensures that teams can manage requirements and risks effectively throughout the product, systems, and software lifecycle. Jama Connect also emphasizes customer success, offering expert support and training to help teams maximize their investment. Ease of use, rapid deployment, pre-configured, well-documented industry frameworks, and in-house subject matter experts provide the fastest time-to-value/ROI without sacrificing quality or safety.
The Clear Advantages of Jama Connect Over Codebeamer
If you’re comparing Jama Connect to Codebeamer, one thing is clear — Jama Connect is the only purpose-built requirements management platform that delivers Live Traceability™ which allows engineering and other teams toquickly and easily access the latest and most complete information for any requirement, no matter the stage of development or tools used. This real-time capability boosts productivity by ensuring teams work with the latest data and reduces risks like delays and defects by finding issues early. In addition, Jama Connect accelerates your product, systems, and software development by managing user needs and product information across the end-to-end development lifecycle.
Only Jama Connect Delivers Live Traceability™ Across Best-of-Breed Tools
Other vendors lock you into inferior platforms. Only Jama Connect seamlessly integrates with your tools-of-choice across engineering teams. And, only Jama Connect can manage the state of development across all integrated teams and tools. Jama Connect’s unique and industry-specific Traceability Information Models define the relationships and expected behavior across teams and tools.
Our customers consistently tell us that they chose Jama Connect over Codebeamer for the following reasons:
1. Ease of Use and High Adoptability
Jama Connect’s intuitive design and user-friendly interface make it easy for teams to adopt and use. Unlike Codebeamer, which can be complex and challenging for new users, Jama Connect ensures that teams can start managing requirements effectively with minimal training. Users insist on a requirements management and traceability solution that is easy to use so that both internal and external stakeholders can efficiently access, share, and review information in a single source of truth, increasing and speeding up the adoption across teams for a better ROI.
The ease of use is not only imperative for users but also for administrators. Jama Connect offers an intuitive and user-friendly administration interface that enables admins to adapt the tool to their organization’s needs without having to learn overcomplicated configuration settings and concepts.
2. Modern Integration and Collaboration Capabilities
Jama Connect provides comprehensive traceability and impact analysis, enabling teams to manage change effectively and reduce the risk of errors. The platform seamlessly integrates with other best-of-breed tools (including Jira and Azure DevOps) in the development ecosystem, ensuring that teams can work efficiently without having to change their other development tools. In contrast, Codebeamer focuses on working solely with other PTC tools and its own limited application lifecycle management (ALM) capabilities.
Modern product and software development requires optimal real-time collaboration between stakeholders. Jama Connect provides an enhanced collaboration experience with its communication streams and advanced Review Center, enabling both internal and external stakeholders with the capabilities to perform formal and iterative reviews.
Jama Connect empowers Intelligent Engineering Management by addressing a critical challenge faced by engineering and product development organizations: the lack of real-time KPIs and metrics during development. This gap often leads to delays, budget overruns, and product defects or recalls. Jama Connect uniquely transforms traceability into a measurable instrument, enabling teams to track real-time metrics and KPIs throughout the product development process. By providing a comprehensive overview of project progress and aligning it with required processes, teams can identify gaps early, mitigate risks, and avoid missed requirements. With its Live Traceability™ and integrations with other best-in-breed engineering tools, Jama Connect ensures that both internal and external data are seamlessly managed, driving informed decision-making and on-time project delivery.
4. Strong Customer Support
We know that our customers need a support team that makes them a priority. That’s why Jama Connect offers unparalleled customer support (including 24/7 support for any production outages), with dedicated customer success teams that work closely with you to ensure you achieve your goals. In contrast, Codebeamer’s support can be limited, making it difficult for your teams to get the help they need when they need it.
5. Scalable and Flexible
Jama Connect is highly adaptable, making it suitable for a wide range of industries and project sizes. Whether your organization is in automotive, aerospace, medical devices, or another industry, Jama Connect can be tailored to meet your specific needs, often getting you up and running quickly with custom-built data frameworks to satisfy your industries regulations and best practices. Additionally, the platform offers flexible deployment options, including cloud and self-hosted, giving you the freedom to choose the best setup for your organization.
6. Fastest Time to Market/ROI
Deploy Jama Connect’s easy-to-use interface in weeks, not months, with easy updates and high performance. Preconfigured frameworks are built-in to satisfy industry regulations and help teams ease the path to compliance, along with in-house industry-focused subject-matter experts and exceptional customer support.
7. Lowest Total Cost of Ownership
With simple and straightforward administration and no need for custom scripting or continuous updating, Jama Connect has the lowest total cost of ownership in comparison to Codebeamer. Jama Connect scales easily without big infrastructure investment, and with unlimited no-cost access for extended internal/external stakeholders, all team members can be involved with additional costs.
Cybersecurity in Unregulated Industries: Proactive Strategies for Mitigating Risk
In today’s modern, digital landscape, cybersecurity threats are not limited to heavily regulated industries like aerospace, automotive, and medical devices. While government mandates drive compliance in regulated sectors, industries without strict cybersecurity oversight for specific products — such as consumer electronics, financial services, insurance, industrial manufacturing, and software development — are increasingly taking proactive steps to address cybersecurity risks. With cyberattacks growing in frequency and sophistication, companies in these industries must prioritize security to protect intellectual property, maintain customer trust, and prevent costly disruptions.
Cybersecurity Challenges in Unregulated Industries
Unlike regulated markets, where adherence to standards such as ISO 21434 (for automotive) or DO-326A (for Aerospace & Defense) is required, many industries operate without formal cybersecurity frameworks. However, recent high-profile breaches have underscored the need for stronger security measures:
Consumer Electronics: A leading smart home device manufacturer recently faced scrutiny after vulnerabilities in its IoT ecosystem allowed hackers to access users’ security cameras. Without strict regulatory oversight, companies must self-impose cybersecurity best practices to safeguard consumer data.
Industrial Manufacturing: A ransomware attack on a global industrial equipment provider disrupted production lines and resulted in significant financial losses. As manufacturers embrace Industry 4.0 and connected systems, cybersecurity must become a core consideration.
Software Development: Open-source software dependencies have become a major target for cybercriminals. The recent exploitation of a widely used software library demonstrated how vulnerabilities in third-party components can create widespread security risks.
Insurance: A major insurance provider suffered a data breach when cybercriminals exploited weaknesses in its cloud-based claims processing system. The breach exposed sensitive policyholder information, including Social Security numbers and financial details, highlighting the need for robust encryption and access controls in an industry handling vast amounts of personal data.
Financial Services: A global investment firm fell victim to a sophisticated phishing attack that compromised employee login credentials, allowing attackers to execute fraudulent transactions. As financial institutions increasingly rely on digital banking and AI-driven trading, strengthening identity verification and fraud detection measures is critical to mitigating cybersecurity threats.
Even without formal regulations, companies in these industries recognize that cybersecurity is a business imperative – and also crucial to remaining trusted and respected in the market. Many are implementing best practices, such as adopting secure development methodologies, integrating threat modeling, and enhancing collaboration between security and development teams.
How Jama Connect® Supports Cybersecurity in Unregulated Industries
While unregulated industries may not face the same compliance pressures as sectors like automotive, medical devices, or aerospace & defense, they still need robust cybersecurity risk management. Jama Connect provides the tools necessary to build a strong cybersecurity foundation by:
Embedding Security into Development Processes: Jama Connect enables teams to integrate cybersecurity considerations throughout product, project, and program development, ensuring that security is addressed from the earliest stages.
Enhancing Collaboration and Risk Visibility: With real-time collaboration and traceability, teams can proactively identify, assess, and mitigate security risks before they escalate.
Facilitating Secure Software Development: By providing structured frameworks for security requirements and risk assessments, Jama Connect helps organizations adopt secure coding practices and threat modeling techniques.
Supporting Industry-Specific Best Practices: Even without formal regulatory requirements, Jama Connect allows organizations to implement cybersecurity frameworks aligned with industry standards such as NIST Cybersecurity Framework and Secure Software Development Lifecycle (SSDLC).
As cyber threats continue to evolve, companies in unregulated industries must take proactive steps to secure their products and operations. By leveraging Jama Connect, organizations can establish a structured, security-first approach that reduces vulnerabilities and builds resilience against emerging cyber risks.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mario Maldari, Brian Morrisroe, and Kenzie Ingram.
Understanding ISO 26550: Managing Variability in Systems and Software Engineering
As products become more complex, companies need better ways to manage different versions and configurations. ISO 26550 helps organizations handle variability in systems and software engineering, making it easier to develop, maintain, and update product lines while ensuring quality and compliance.
What is ISO 26550?
ISO 26550, Software and Systems Engineering — Reference Model for Product Line Engineering and Management, provides a framework for managing product variations. It helps organizations develop multiple product versions efficiently by identifying shared components and differences, reducing duplication, and improving consistency.
Jama Connect makes it easier to follow ISO 26550 by providing:
Live Traceability™: Tracks changes across product versions to maintain compliance.
Variant Management: Helps teams manage multiple configurations efficiently.
Requirements Management: Organizes and links requirements across product lines.
Collaboration & Reviews: Improves teamwork and decision-making.
Compliance & Audit Support: Provides workflows and reports to simplify audits.
Conclusion
ISO 26550 helps organizations manage product variability effectively, improving efficiency and compliance. Jama Connect supports this by providing tools for traceability, variant management, and collaboration. If your organization needs a better way to handle product variations, Jama Connect can help simplify the process.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Matt Mickle, McKenzie Ingram, and Decoteau Wilkerson.
Jama Software and :em AG Announce Strategic Partnership to Drive Efficiency in Requirements Management
Jama Software a leading provider of requirements management and traceability solutions, is pleased to announce a strategic partnership with :em AG. This collaboration brings together Jama Software’s industry-leading platform, Jama Connect®, with :em AG’s expertise in process and method consulting to help organizations streamline product development, enhance compliance, and mitigate risk.
Jama Connect empowers teams with real-time collaboration, Live Traceability™, and comprehensive requirements, risk, and test management, enabling them to navigate complex regulatory environments with confidence. Through this partnership, :em AG will support customers in seamlessly integrating Jama Connect into their development workflows — including variant management, risk management, and test management —while providing expert guidance on configuration and adoption.
“We are excited to partner with :em AG to expand the reach of Jama Connect and help more organizations overcome the challenges of increasingly complex product and software development,” said Tom Tseki, Chief Revenue Officer at Jama Software. “Together, we are enabling teams to accelerate innovation while decreasing risk by ensuring end-to-end traceability and regulatory compliance.”
Dr. Marcus Krastel, Member of the Board of :em AG, added, “We are delighted to have Jama Software, another leading provider of requirements management software, as a partner and to be able to address new customers with our services. Together, we are driving forward the digital transformation and offering solutions for the increasingly complex work with requirements and regulations.”
About Jama Software
Jama Software is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
For more information about Jama Connect services, please visit jamasoftware.com/
Strengthening Cybersecurity in Regulated Markets: How Jama Connect® Enhances Risk Management in Product Development
Discover how Jama Connect® empowers product development teams in regulated markets like aerospace, automotive, and medical devices to integrate cybersecurity and safety risk management with requirements management
In today’s connected world, cybersecurity is a critical concern for product development in regulated markets. According to a recent report by Cybersecurity Ventures, cybercrime is predicted to cost the world $10.5 trillion annually by 2025, underscoring the growing risks facing industries that rely on connected products.
As products become increasingly software-driven and connected, they present new vulnerabilities that require robust security measures. Industries such as aerospace, automotive, and medical devices must navigate complex cybersecurity regulations to protect sensitive data, ensure product safety, and maintain compliance with evolving standards. Failure to address cybersecurity risks not only jeopardizes user safety but can also lead to costly delays, recalls, regulatory penalties, and reputational damage.
The Importance of Cybersecurity in Regulated Markets
Regulated markets operate under strict guidelines to protect data, ensure operational integrity, and maintain public trust. Cybersecurity compliance involves adhering to laws, standards, and regulatory requirements established by governments and industry authorities to safeguard digital information and systems from threats like unauthorized access, data breaches, and cyberattacks.
Recent incidents underscore the urgency of robust cybersecurity measures:
Medical Devices: The U.S. Food and Drug Administration (FDA) issued updated guidance requiring medical device manufacturers to submit cybersecurity plans as part of their premarket submissions. This move follows increasing concerns about vulnerabilities in connected medical devices that could jeopardize patient safety and data security.
Automotive Industry: A notable cybersecurity breach involving a major automaker demonstrated how connected vehicles can be remotely accessed and controlled. This incident has accelerated the push for stricter compliance with ISO 21434, the international standard for automotive cybersecurity risk management.
Aerospace & Defense: Cyberattacks targeting defense contractors have highlighted the need for stringent cybersecurity protocols. The implementation of DO-326A and other cybersecurity standards is becoming increasingly critical to protect sensitive information and ensure the safety of airborne systems.
Jama Software’s Approach to Cybersecurity in Regulated Markets
Jama Software recognizes the critical importance of cybersecurity in regulated industries and has integrated out-of-the-box cybersecurity risk management capabilities into its industry-specific frameworks for Jama Connect. This integration facilitates a proactive approach to cybersecurity across various sectors, including airborne systems, automotive, and medical devices.
Aerospace & Defense
Aircraft, system, and subsystem manufacturers and their suppliers benefit from a customizable solution with a robust REST API aligning all cybersecurity activity with an integrated DevSecOps CI/CD pipeline, easy collaboration and reviews involving internal and external teams, and customizable reports to demonstrate compliance with the “Airworthiness Security Process Specification” (DO-326A). Jama Connect for Airborne Systems provides a framework to identify potential cyber threats, assess vulnerabilities, and implement security measures.
Automotive Industry
The shift towards software-defined vehicles has introduced new cybersecurity challenges. Jama Connect for Automotive offers OEMs and suppliers the capability to develop necessary work products that comply with ISO 21434 for cybersecurity management. It offers comprehensive cybersecurity diagnostics including Threat Analysis and Risk Assessment (TARA) templates and reports, as well as case management, progress monitoring, and reporting features to demonstrate compliance. By facilitating collaborative planning, validation, and alignment, it reduces risks through enhanced collaboration among specialized teams, removes guesswork from threat analysis, and accelerates project launches through efficient reuse of components.
Medical Device Industry
For medical device manufacturers, managing cybersecurity risk under standards like ANSI/AAMI SW96:2023 is complex. Jama Connect for Medical Devices harmonizes cybersecurity and safety risk management, simplifying complex risk evaluations and accelerating responses to threats. This integration reduces complexity, increases efficiency in managing risks, and ensures comprehensive documentation of traceability, which is crucial for regulatory compliance and patient safety. By embedding cybersecurity risk management into its industry-specific frameworks for Jama Connect, Jama Software empowers organizations to integrate cybersecurity risk management into product development processes for efficient and proactive identification, evaluation, and mitigation of cybersecurity risks, compliance with regulatory standards, and enhanced overall security posture of their products.
As cybersecurity threats continue to evolve, regulated industries must take proactive steps to safeguard their products, data, and users. The growing complexity of cybersecurity regulations highlights the need for robust risk management frameworks that integrate security into every stage of the product development lifecycle. By leveraging Jama Connect’s industry-specific cybersecurity capabilities, organizations can streamline compliance efforts, enhance collaboration, and mitigate risks more effectively. Investing in secure-by-design practices today ensures a safer and more resilient future for the products and industries that shape our world.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mario Maldari and McKenzie Jonsson.
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