Purpose-built support for automotive systems and components, ensuring compliance with ISO 26262, ISO 21434, ASPICE, and other critical industry standards.
Centralized platform for managing requirements, tests, risks, and traceability with end-to-end visibility.
Tools for improving productivity, reducing defects, and ensuring seamless traceability to meet safety and security standards.
With Jama Connect, automotive teams can reduce rework, prevent recalls, and bring products to market faster while staying audit-ready.
Plus, leverage pre-configured frameworks and work with Jama Connect consultants to customize the solution to your exact business needs.
Grant Rhodes: Hello, and welcome to the Jama Connect Features in Five series. My name is Grant Rhodes, and I’m a Senior Solutions Consultant here at Jama Software.
Today, we’ll be walking through the automotive solution. Jama Software provides robust tools and solutions to help automotive developers streamline compliance with ISO 26262, ISO 21434, ASPICE, and other critical industry standards.
Centralized Management with Jama Connect
Through Jama Connect, teams can manage requirements, tests, risks, and traceability in a centralized platform, ensuring end-to-end visibility across the development cycle.
This level of traceability is crucial for demonstrating adherence to safety and security standards. It enables significant productivity and quality improvements, dramatically reduces the risk of product delays, cost overruns, defects, rework, and recalls, and ultimately results in faster time to market.
The Jama Connect automotive solution is a complete set of frameworks, example projects, and procedural documentation intended to accelerate the implementation of Jama Connect for organizations developing automotive systems and components. The foundation of our automotive solution is Jama Connect, our industry-leading, best-in-breed requirements management solution.
Purpose-Built for Automotive Development
Purpose-built to track the requirements of complex systems and reduce risk and inefficiencies of document-based legacy systems, the automotive solution allows teams to start working in Jama Connect with zero setup and configuration time. Alternatively, teams can work with a Jama Connect consultant to customize the solution to meet their company’s exact business needs.
Rhodes: The automotive solution frameworks come in the form of projects in Jama Connect. These include definitions of item types and relationships as well as example project hierarchies that are aligned to key industry regulations. Here, I have the base automotive framework project open.
This image represents the traceability information model applied within this project and visualizes the allowable data types and relationship rules. Requirements are covered by lower-level requirements or design elements and are related to test case items to prove compliance. In addition to the item types and relationships, each framework also contains a project structure designed to highlight important sets of data.
These models and hierarchies have been designed using input from industry best practices and are usable out of the box. However, Jama Connect is configurable and can be customized to meet any needs specific to your organization or product development cycle.
Sample Projects for Hands-On Experience
In the project tree, we can see that in addition to the framework projects, the solution also delivers sample projects.
These utilize a framework but are populated with sample data. In these projects, teams can get hands-on experience with the defined item types and relationships. For example, opening the automotive safety and security sample set project, we can see an example of a hazard analysis and risk assessment (HARA).
Rhodes: The automotive solution also includes many export templates and reports for generating HTML, PDF, Word, and Excel outputs from the system.
Some reports are generic and included in all Jama Connect instances. Others are targeted for automotive customers, providing content and formatting specific to industry needs. For example, the HARA and TARA reports give the ability to export safety and security items from a project. Since the sample set project is populated with data, we can use it to better understand the outputs that these reports deliver.
Conclusion
Thank you for watching this Features in Five session on the automotive solution for Jama Connect. Existing customers, if you want to learn more, please reach out to your Customer Success Manager or Consultant. New customers, if you are not yet a client, please visit our website at JamaSoftware.com to learn more about the platform and how we can help you optimize your development process.
A Practical Guide to Translating User Needs into Design Inputs
As a former product development engineer, I remember the pressure to start designing immediately. I’d jump straight into CAD models and prototypes, eager to build the next innovative medical device. But sometimes, this meant I overlooked a critical first step: truly understanding what the end-user needed. This often led to features that missed the mark and created a mountain of documentation rework to justify our design choices after the fact.
Many engineers in the medical device space get stuck in this cycle. They struggle to distinguish between user needs and design inputs, or they don’t know how to translate a general user request into a measurable engineering requirement. This confusion isn’t just inefficient; it’s a compliance risk that can delay projects and frustrate teams who would rather be designing and testing than drowning in paperwork.
TL;DR: User needs are high-level goals describing what a user wants a device to do, while design inputs are the specific, measurable engineering requirements needed to meet those needs. Following a structured process to translate user needs into traceable design inputs is essential for complying with FDA regulations and building products that succeed.
What are User Needs? The Foundation of Your Design Control Process
User needs are the starting point for the entire medical device design control process. They are high-level, qualitative statements that capture the goals and expectations of the device’s intended users. Think of them as the “what” from the user’s perspective.
These needs are derived from various stakeholder needs, which can include patients, surgeons, nurses, technicians, or even hospital administrators. The key is to capture their desired outcomes without dictating a specific technical solution.
According to FDA 21 CFR 820.30, the design control process begins with establishing and maintaining procedures to ensure that the design requirements are appropriate and address the intended use of the device, including the needs of the user and patient.
Examples of User Needs:
A surgeon needs the device to provide clear visualization in a smoke-filled environment.
A home-care patient needs the device to be simple to operate without assistance.
A nurse needs the device to be easily and quickly sterilized between uses.
What are Design Inputs? The Blueprint for Your Device
If user needs are the “what,” design inputs are the “how”— from an engineering perspective. They are the detailed, objective, and verifiable requirements that describe the performance, physical, and functional characteristics of the device. Every design input must be traceable back to a specific user need.
These inputs form the technical blueprint that guides the entire development process. They must be unambiguous and measurable so that you can later prove the device meets them through design verification activities.
Key takeaway: Without clear design inputs, you have no objective criteria to design against or to test your final product.
Examples of Design Inputs (translated from the user needs above):
User Need: A surgeon needs clear visualization.
Design Input: The device’s camera shall operate in temperatures up to 60°C.
Design Input: The device’s lens shall be coated with an anti-fog agent.
User Need: A patient needs a simple device.
Design Input: The device shall have no more than three buttons for all primary functions.
Design Input: The device startup sequence shall complete in under 5 seconds.
User Need: A nurse needs easy sterilization.
Design Input: The device housing shall be made of medical-grade stainless steel 316L.
Design Input: The device shall withstand at least 100 autoclave sterilization cycles at 134°C.
A 4-Step Guide for Translating User Needs to Design Inputs
Translating vague user needs into concrete design inputs is a skill. It requires a systematic approach to ensure nothing is lost in translation. Following these steps will help you create a robust foundation for your medical device design control process.
Step 1: Gather and Define Clear User Needs
Before you can translate needs, you must capture them accurately. This involves engaging directly with your stakeholders through methods like interviews, surveys, and observational studies. Focus on understanding their goals and pain points. Write the user need from their perspective, avoiding technical jargon.
Step 2: Deconstruct Each User Need
A single user need can contain multiple implied requirements. Break down broad statements into their core components. For a need like, “The device must be portable,” ask clarifying questions:
What does “portable” mean to the user? Carried in a pocket, in a bag, or on a cart?
How long does it need to operate without being plugged in?
In what environments will it be used?
Step 3: Write Quantifiable and Verifiable Design Inputs
This is the most critical step. Convert each component of the user need into a specific, measurable requirement. A good design input is unambiguous and testable.
Use “shall” statements: This is standard practice for writing formal requirements.
Be specific: Instead of “lightweight,” write “The device shall weigh less than 500 grams.”
Make it measurable: Instead of “a long battery life,” write “The device shall operate continuously for a minimum of 8 hours on a single charge.”
Step 4: Establish and Maintain Traceability
Every design input you create must be linked directly back to the user need it helps fulfill. This traceability is not optional; it’s a regulatory requirement and the backbone of your medical device file. This link proves that your design is directly driven by user needs and that every requirement has a purpose.
Streamline Your Design Control Process with the Right Tools
Managing the complex web of user needs, design inputs, risks, and verification activities in spreadsheets or documents is a recipe for errors and audit findings. This is where modern requirements management platforms can transform your workflow.
Live Traceability™: Automatically create and visualize the links between user needs, design inputs, test cases, and other artifacts. This ensures you are always audit-ready and can easily analyze the impact of any changes.
Reuse and Libraries: Stop reinventing the wheel. Create libraries of common requirements, like those for specific standards or product lines, and reuse them across projects to ensure consistency and save valuable time.
AI-Powered Insights: With Jama Connect Advisor™, you can leverage AI to analyze your requirements for quality. Get instant feedback on whether your design inputs are clear, complete, and verifiable, helping your team write better requirements faster.
Q: Can a single user need lead to multiple design inputs? A: Yes, absolutely. A high-level user need like “the device must be safe for clinical use” will be broken down into dozens or even hundreds of specific design inputs related to biocompatible materials, electrical safety standards, alarm functionalities, and much more.
Q: What’s the difference between design inputs and design specifications? A: This is a common point of confusion. Design inputs define what the device must do (the requirements). Design specifications (also known as design outputs) describe how the device will meet those requirements. They are the tangible results of the design process, such as drawings, material specifications, and source code. People often think of the design outputs as the “recipe” showing how to build the device.
Q: How do I handle conflicting user needs? A: It’s common for different stakeholders to have competing needs (e.g., a large screen for visibility vs. a small size for portability). This requires a structured process of prioritization, risk analysis, and trade-off discussions with the project team and stakeholders. The key is to document these decisions and the rationale behind them within your design history file.
Master Your Design Inputs and Accelerate Innovation
Bridging the gap between user needs and design inputs doesn’t have to be a source of frustration. By adopting a structured process and leveraging the right tools, you can eliminate ambiguity, ensure compliance, and free up your engineers to do what they do best: build innovative products that improve lives.
BrightInsight Drives Efficiency Using Jama Connect
ABOUT BRIGHTINSIGHT
BrightInsight is a trusted partner for top life sciences companies, delivering regulated digital health solutions like Software as a Medical Device (SaMD) that transform patient care. In collaboration with leading BioPharma and MedTech firms, BrightInsight has developed pioneering solutions across more than 11 therapy areas.
CUSTOMER STORY OVERVIEW
Operating in a highly regulated industry, BrightInsight navigates strict deadlines, complex regulatory requirements, and dynamic client expectations. To maintain its competitive edge, the company needed a robust requirements management tool to refine its processes. A key challenge was integrating cybersecurity into its overall patient safety risk management framework.
By implementing Jama Connect, BrightInsight created a novel, integrated approach to risk management. This allowed them to automate traceability, optimize documentation, and significantly improve project efficiency. As a result, BrightInsight has reduced risk assessment activities by more than 50% and accelerated project timelines, all while ensuring comprehensive cybersecurity and patient safety.
“We’ve been able to link cybersecurity risks back into patient hazards, which is something many companies struggle to do. Jama Connect’s traceability and item relationships make that possible.” – Lucas Holt, Director of Systems Engineering, BrightInsight
WITH JAMA CONNECT, USERS EXPERIENCE:
Ability to seamlessly link cybersecurity risks to patient safety hazards, creating comprehensive risk models that improve safety and compliance.
Optimized workflows and reusable requirement repositories help users reduce project timelines by months, expediting product launches and increasing efficiency.
Real-time feedback tools and robust traceability features streamline collaboration while ensuring audit-ready documentation that impresses regulators.
“Jama Connect really forces you to think about traceability right from the get-go of the project, where in the old way of doing it, traceability was often an afterthought. It’s the right way to do it.” – Lucas Holt, Director of Systems Engineering, BrightInsight
CHALLENGES
Before implementing Jama Connect, BrightInsight faced several industry-wide challenges that hindered its ability to innovate safely and efficiently.
Fragmented Risk Management: Managing cybersecurity and patient safety risks in separate streams resulted in disjointed assessments. This separation made it difficult to understand the true impact of a cyber threat on patient health.
Inefficient Documentation: Manual processes using Word and Excel were inefficient, prone to error, and limited collaboration across global teams.
Cumbersome Traceability: The document-first approach made tracing relationships between requirements, risks, and test cases a time-consuming manual task, often delaying regulatory submissions and product launches.
BrightInsight leveraged the powerful features of Jama Connect to build a unified and efficient development process, with a groundbreaking approach to risk management.
A Novel Approach to Cybersecurity Risk The most significant change was integrating cybersecurity directly into patient safety risk management. Using the powerful traceability features in Jama Connect, BrightInsight linked cybersecurity threat models directly to patient hazards. This innovative structure allows them to create comprehensive risk models connecting assets, vulnerabilities, and threats to specific patient safety outcomes.
Item-Based Management for Seamless Traceability Jama Connect’s item-first approach enabled BrightInsight to manage traceability from the very beginning of a project.
Optimized Reuse and Standardization BrightInsight created reusable requirement repositories, particularly for common elements like cloud-based services. New projects can now pull from this “off-the-shelf” library of pre-built modules with fully linked requirements, risks, and testing frameworks.
Streamlined Reviews and Collaboration Jama Connect’s Review Center replaced lengthy meetings with real-time, asynchronous collaboration. Teams can now access shared projects, provide feedback, and monitor revisions, dramatically improving review timelines.
“The reusability of items, requirement sets, and risk management really shines for us, it has significantly reduced our design cycles.” – Lucas Holt, Director of Systems Engineering, BrightInsight
OUTCOMES
Since implementing Jama Connect, BrightInsight has achieved measurable improvements, solidifying its position as an industry leader.
Faster Cybersecurity Risk Assessments: By integrating and standardizing its processes, the team reduced the time for cybersecurity and patient safety risk evaluations from six weeks down to just two.
Boosted Overall Efficiency: Optimized workflows have expedited product launches, allowing BrightInsight to reduce project timelines by three to six months for its pharma clients.
Enhanced Regulatory Confidence: During audits, BrightInsight can now produce audit-ready documentation with full traceability instantly. This organized, structured approach leaves auditors impressed and confident in their compliance.
Improved Client Satisfaction: Faster turnarounds and greater assurance of quality documentation have led to increased trust and stronger, more successful business relationships.
Preventing a $400 Million Mistake: Why Digital Traceability is Critical in AEC
On November 19, 2025, Amazon announced the indefinite closure of its LIT1 fulfillment center — a $400 million hub at the Port of Little Rock — eliminating 4,100 planned jobs. The reason cited? “Unfixable flaws” in the structure (see article). It turns out that the company’s largest fulfillment center in Arkansas that has been operating since 2021 wasn’t designed to be compliant with the Arkansas Fire Prevention Code that includes seismic safety provisions relevant to the New Madrid Seismic Zone that includes Arkansas.
In large-scale construction and engineering projects, disjointed data often leads to failure. When requirements, such as state building codes, safety regulations, or load-bearing specifications, live in static documents or spreadsheets, they become disconnected from the actual design and verification processes.
If state mandated structural requirements conflict with an architectural design, manual processes often fail to flag the issue immediately. By the time the error is discovered, the structure is built, and the flaw may be deemed “unfixable.”
Jama Connect mitigates this risk through Live Traceability™ that creates a digital thread connecting regulatory and other requirements directly to specific design elements and verification tests across the project software toolchain. If a requirement changes or a test fails, the impact is immediately visible across the entire project. This allows teams to identify non-compliance issues in the digital design phase — long before they become physical, expensive, “unfixable” problems.
Building codes are not suggestions; they are mandates that involve complex layers of fire safety, seismic durability, and occupancy standards. Engineering designs used to construct buildings successfully used in some states may not be reusable as is in other states. As one of seven states in the New Madrid Seismic Zone, Arkansas mandates that structures be designed to adequately resist seismic forces during earthquakes.
Using a requirements management platform allows teams to:
Decompose Regulations: Break down the state’s specific complex safety, fire and other building codes into individual, trackable requirements.
Link Verification to Requirements: Ensure every single code requirement has a specific test or verification method linked to it.
Monitor Compliance Status: View real-time dashboards showing exactly which parts of the build are compliant and which are at risk.
In the case of Amazon’s Arkansas hub, a digital engineering compliance framework could have flagged the non-compliant design elements during the building design stage, prompting a relatively quick fix with a cost measured in hours of engineering time, rather than closer of an occupied, active building surrounded by uncertainty about the possibility and cost of bringing the building into compliance.
Reducing Risk Through Collaboration
Complex projects involve diverse teams — architects, structural engineers, regulatory bodies, contractors, and owners. When these stakeholders operate in silos, critical information falls through the cracks.
Jama Connect serves as a single source of truth providing everyone with access to the latest information and enabling collaboration that is crucial for risk management. When a regulatory requirement lacks verification, the lack of traceability is called out. When an engineer proposes a change, the platform analyzes the downstream impact: Will this change violate a safety code? Will it conflict with a mechanical system requirement?
By centralizing communication around the requirements themselves, organizations ensure that everyone is building toward the same, compliant outcome. This alignment is the primary defense against the late-stage discovery of structural failures.
The elimination of 4,100 jobs and the abandonment of a major fulfillment hub underscore a critical industry lesson: manual documentation methods that are prone to human error are insufficient for modern, high-stakes engineering.
To avoid a similar fate, organizations must embrace digital engineering tools that automate traceability and compliance checks so that their teams can reduce manual effort and focus on innovation and safety. Using Jama Connect will help ensure that by the time construction begins, a successful outcome is guaranteed. In an industry where mistakes cost hundreds of millions, digital traceability is the most effective insurance policy available.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Joe Gould, Kevin Andrewjeski, and Mark Levitt.
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from Bosch, titled “Bosch and the chiplet revolution: Enabling software-defined mobility”, written by Michael Budde, President of Bosch Mobility Electronics.
Bosch and the chiplet revolution: Enabling software-defined mobility
The shift to software-defined mobility demands an unprecedented level of computational power, flexibility, and scalability as OEMs seek to develop software-based approaches to vehicle functionality and user experience.
While powerful, traditional System-on-Chips (SoCs) are reaching their technical limits in this evolving landscape. The sheer complexity of integrating multiple functions onto a single chip is becoming increasingly challenging – making development cycles longer, increasing costs, and reducing flexibility for future upgrades.
At Bosch, we see chiplet technology not only as technical innovation, but also as a potential breakthrough for software-defined mobility. – Michael Budde, President of Bosch Mobility Electronics
Chiplets: A modular solution for software-defined vehicles
With modular components that can be perfectly tailored for specific automotive applications, chiplets are emerging as a game-changer that can replace large, inflexible semiconductors. However, without common standards, the true benefits of chiplets cannot be fully realized as they risk remaining locked behind proprietary silos.
At Bosch, we’ve recognized that pursuing an open ecosystem for chiplet technology is critical for the advancement of software-defined mobility. This is reflected in our active involvement in several collaborative initiatives with major actors from industry and research.
Building an open ecosystem for automotive chiplets
Most recently, Bosch has taken a leading role in the CHASSIS initiative – which stands for Chiplet-based Architectures for Software-Defined Vehicles. With funding from the European CHIPS Joint Undertaking (CHIPS JU), the three-year project brings together multiple heavyweights from the European automotive, semiconductor, and software industries, as well as major research institutions. With strong partners like BMW, Renault, Stellantis, and many others, CHASSIS marks a clear milestone toward building the universal standards that will make chiplet technology viable for automotive applications. By establishing joint standards and fostering multi-vendor interoperability, CHASSIS lays the foundation for a scalable and sovereign chiplet ecosystem in Europe.
The transformative benefits of chiplets
While automotive chiplet technology is still in the early stages of development, there is no question that chiplets offer several major advantages for software-defined vehicles (SdVs) – first and foremost modularity and flexibility. SdVs require a range of computing resources, from high-performance processors for autonomous driving to energy-efficient microcontrollers for body control. With chiplets, we can design and integrate these specialized components independently, creating customized solutions for different vehicle domains or even specific customer needs. This modularity also makes upgrades and replacements of individual chiplets easier. In turn, this extends the lifespan of the underlying hardware and supports over-the-air (OTA) updates for new functionalities – a cornerstone of software-defined vehicles.
Second, chiplets address the ever-growing demand for performance and power efficiency. As autonomous driving algorithms become more sophisticated and user interfaces more immersive, computational requirements are increasing. Chiplets make it possible to combine different types of mini-chips, each made with the best technology for its specific job, into one powerful package. In turn, this enables superior performance where needed while maintaining energy efficiency in less demanding areas, which is especially important for electric vehicles and their range.
Third, cost-effectiveness and faster time-to-market are significant drivers. Developing a complete, monolithic SoC for every new vehicle platform is a resource-intensive endeavor. By allowing the reuse of proven intellectual property (IP) and the independent development of specialized blocks, chiplets significantly reduce design complexity and speed up development cycles. This agility is vital for OEMs: in a fast-paced market, staying ahead of the curve in software-driven features is a competitive necessity.
Finally, and perhaps most importantly, chiplets can play a central role in managing complexity and mitigating risk. The interactions between hardware and software in SDVs make a robust and adaptable architecture decisive. By breaking down complex SoCs into smaller, manageable chiplets, we can isolate potential issues, simplify debugging, and accelerate validation processes. This streamlined approach minimizes the risk of costly redesigns and delays, thus ensuring the reliable and safe operation of advanced automotive systems.
At Bosch, we see chiplet technology not only as technical innovation, but also as a potential breakthrough for software-defined mobility. It unlocks the architectural freedom, performance scalability, and economic viability required to build the intelligent and adaptable vehicles of the future. However, the technology’s full potential can only be reached through open standards and strong collaboration across the automotive and semiconductor industries. By working closely with our partners, we at Bosch believe that we can shape a modular, sovereign, and future-proof compute landscape for mobility.
Automotive chiplets: Your questions answered
This FAQ provides insights into automotive chiplets, their importance for software-defined mobility, and Bosch’s role in their development and standardization.
What are chiplets?
Chiplets are small, specialized silicon pieces, or “mini-chips,” that act as modular building blocks for semiconductor design. Instead of integrating all functions onto a single, large “monolithic” chip (System-on-Chip or SoC), chiplets allow for the distribution of computing tasks across several smaller, optimized components. These individual chiplets are then connected with a high-speed interface to function as a single, powerful system.
Why are chiplets important for software-defined mobility (SDM)?
The shift to software-defined mobility demands unprecedented computational power, flexibility, and scalability. Traditional monolithic SoCs are reaching their technical limits in meeting these demands for the following reasons:
Complexity: Integrating multiple functions onto a single chip is becoming increasingly challenging, and this is leading to longer development cycles and higher costs
Flexibility: Monolithic SoCs offer less flexibility for future upgrades or tailoring to specific automotive applications
Costs: Monolithic SoCs incur significant design costs. This limits their viability, making new designs feasible only for large-volume markets like smartphones, but increasingly uneconomical for automotive applications.
Chiplets offer a solution by providing:
Modularity and differentiation: They allow for customized solutions for different vehicle domains (e.g., autonomous driving, body control, OEM-specific AI accelerators) or even specific customer needs, making upgrades, variants and replacements easier
Performance and power efficiency: Different chiplets can be optimized for specific tasks, combining high-performance processing where needed with energy efficiency in other areas. This is especially important for electric vehicles
Cost-effectiveness and faster time-to-market: By reusing proven intellectual property (IP) and developing specialized blocks independently, chiplets reduce design complexity and accelerate development cycles. This is decisive for competitive innovation
Complexity management and risk mitigation: Breaking down complex systems into smaller, manageable chiplets simplifies debugging and validation. It also isolates potential issues, thus reducing the risk of costly redesigns
What is the CHASSIS initiative?
CHASSIS (Chiplet-based Hardware Architectures for Software-Defined Vehicles) is a three-year CHIPS JU (Chips Joint Undertaking) European pre-competitive program coordinated by Bosch. It is the first Europe-based initiative aiming to accelerate the development, standardization, and industrialization of automotive chiplet technology for software-defined mobility.
Who is involved in the CHASSIS project?
CHASSIS unites 18 leading companies from Europe’s mobility, semiconductor, and software industries, alongside prominent research institutions. This includes:
Major European OEMs: BMW, Renault/Ampere, CRF Stellantis
Research and technology organizations: CEA, CHIPS-IT, FMD, imec
What are the main goals of the CHASSIS initiative?
Chassis aims to prove the viability of chiplets for automotive applications while also building the architectural foundation and meeting market demand.
The CHASSIS initiative will:
Create scalable, high-performance chiplet platforms specifically designed for automotive use
Define clear integration rules and specifications for seamless chiplet-to-chiplet connectivity from different vendors
Foster a modular, secure, and resilient open chiplet ecosystem in Europe
Develop and validate an ‘Automotive Base Die’ (the automotive backbone) chiplet as well as a test chip consisting of multiple chiplets to demonstrate multi-vendor integration
Enable an ecosystem for chiplets with a strong European backbone
Why is an open ecosystem and standardization important for automotive chiplets?
Without common standards, the true benefits of chiplets cannot be fully realized. An open ecosystem and common standards:
Prevent chiplets from being locked behind proprietary silos
Ensure that different components from various suppliers can work together seamlessly
Promote competitive innovation and open up the high-performance compute market to multiple vendors
Enable the automotive industry to benefit from a global, scalable chiplet ecosystem
Strengthen Europe’s technological sovereignty in semiconductor design
What is Bosch’s position in the automotive chiplet revolution?
Bosch aims to become the go-to provider for automotive chiplet systems and shape the future of automotive computing itself through open standards. The company is doing this by:
Coordinating the CHASSIS initiative: taking a leading role in bringing together key industry players and research institutions
Driving standardization: Actively working with partners to create common standards for automotive chiplets
Shaping the future: Influencing key design choices and architectures to ensure chiplet technology meets the evolving needs of software-defined vehicles
Comprehensive expertise: Leveraging its deep understanding of both automotive systems and semiconductor design and integration
How will chiplet innovation ultimately benefit the automotive industry and consumers?
Chiplet innovation will benefit the industry by:
Enabling more advanced, flexible, and powerful software-defined vehicles
Reducing development cycles and costs for OEMs
Allowing for easier upgrades and extended hardware lifespans in vehicles
Fostering competition and innovation among semiconductor suppliers
Enabling flexibility in E/E architecture design for OEMs based on needs and not limited to available SoCs
What are the benefits of automotive chiplets for consumers?
Vehicles with more sophisticated and customizable features
Enhanced safety and user experiences through advanced functionalities like autonomous driving
Longer-lasting vehicles with the ability to receive over-the-air (OTA) updates for new features
More energy-efficient vehicles, which is especially important for electric models
Jama Connect for Semiconductors provides a purpose-built solution for managing requirements, traceability, and engineering governance across the semiconductor product lifecycle.
This scalable framework is designed to meet the unique needs of semiconductor teams, enabling faster adoption and seamless integration into your development processes.
Watch our vlog to listen to Jama Software’s Neil Stroud – General Manager, Automotive & Semiconductor, and Steve Rush – Principal Solutions Consultant, discuss how semiconductor teams can streamline development and improve collaboration with Jama Connect for Semiconductors, which includes:
Templates tailored to semiconductor use cases, from MRD management to post-silicon validation
Comprehensive procedure and configuration guides
Best practices for IP reuse and traceability
Integration resources for tools like Jira and pre-silicon testing platforms
Transform your semiconductor development process with Jama Connect and drive innovation with confidence.
Jama Connect for Semiconductors: Simplify Complexity, Accelerate Innovation
Neil Stroud: Hi. My name is Neil Stroud. I’m General Manager of our semiconductor business unit, and I’m joined here by Steve.
Steve Rush: Hi there. I’m Steve Rush, Principal Solutions Consultant on our semiconductor team. Happy to be here today.
Stroud: Hey, Steve. So we’ve got some exciting news to introduce to you today. But before we get into that, I wanted to introduce some context. So, Jama Connect has pretty much become the de facto standard across the whole semiconductor industry. And when we look at that industry, obviously, that’s made up of a number of subsegments such as IP vendors, fabless semiconductor, foundry, EDA tools, and we cover the whole gamut of the ecosystem.
We’ve been helping customers for a long time, managing that complexity, not only with the semiconductor side of the development, but also we see increasingly where the software stack is part and parcel of the whole solution that the semiconductor ecosystem provides. So there are many aspects to it. Of course, compliance is a key part as we see products go into things like safety and security solutions.
So we’re driving that acceleration, that innovation, that time to market, that improved quality. So we’ve been doing this for a while. We’ve gotten to understand the problems intimately. Steve, maybe you can comment. What have you learned from engaging with these semiconductor customers?
Rush: Their challenges are complex. Their products are mind-bogglingly complex. I hear a lot of consistent challenges through the industry around traceability, engineering governance, and how they can create a consistent data model to work against.
Reuse is a huge aspect of what they do. How do I reuse my existing IP in a different context or customization that I am working on with my customers? And, frankly, Jama Connect is really well aligned to solve some of these problems. But speaking semiconductor language, meeting our customers where they are, how you actually perform this and do this in Jama Connect, has always been sort of a bit of a mystery. And we’re excited about this new semiconductor solution that we’re gonna talk about today, sort of unpack a little bit about that, and speak more semiconductor language, tune these to the solutions that this, you know, wide-ranging industry is looking for.
Stroud: Yeah. Excellent. And I just wanna pick up on a phrase that you used there that’s near and dear to my heart. You mentioned engineering governance, and I think we’re kind of at an inflection point, it feels, from the various conversations we’re having with our customers who are using Jama Connect today, but also customers who are thinking about using it. This whole concept of engineering governance and, you know, trying to get oversight and control over the whole engineering organization, which typically, historically, has been, you know, hardware and software as two independent domains.
This whole concept of engineering governance, where you can unify those two worlds, which, let’s face it, are very different. You know, we’ve got semiconductor hardware development that typically is more classical waterfall v model versus software, which is Agile, you know, CICD, going at a hundred miles an hour kind of thing. So, maybe you can just comment a little bit more about that engineering governance and how Jama Connect has a role to play there.
Rush: Yeah. I mean, the intersection of hardware and software, we see that across many industries. But I would say semiconductor, probably more than any other industry that I’ve worked with, relies so much on institutional knowledge that that probably is keeping, you know, their C-Suite and the managers sort of up at night that they’re so reliant on existing knowledge and how that knowledge sort of transfers from people to people and from team to team is just a huge challenge. And I think part of what this solution and Jama Connect bring to bear is that it creates more transparency and accountability, helps you identify risks early on in the process to allow you to sort of shift left in that process to sort of get those requirements right before you have to figure out you need to change, like, much further down the stream.
They’re looking for something more lightweight that users can adopt. The way that they work is not ultimately gonna change, but it’s gonna improve.
So by shifting the way that we think about requirements and engineering data and putting that into a very configurable model that can create consistency, and we talk about sort of, like, common enough in a lot of our blogs and frameworks. We want a common enough framework that people can work against, that’s unified, that we can report against, but still allow teams sort of have that autonomy to make tweaks and customizations for their particular use cases. And I think Jama Connect really strikes that balance, and this solution in particular does that.
Stroud: Great. And that’s a great segue into the big news. What are we announcing today?
Rush: We are very excited to announce a brand new semiconductor solution for Jama Connect. So what this solution is is a brand new set of templates, more agnostic in terms of use case. Honoring systems engineering but tuning these templates to really common semiconductor use cases for your EDA companies, your IDM companies, the way that they think and see the world, really, those customers need a way and a perspective to visualize how they might set their data up in Jama Connect, and we’re giving them that new great starting point. So this new solution, including these new templates, is something that we’re really excited about. There’s an exhaustive procedure guide that explains how to work in Jama Connect from high-level MRD all the way down to post-silicon validation, including some aspects.
Stroud: So, how do I reuse IP cores across different IT blocks that I’m managing? What does that look like exactly? How do I manage that? What does good look like in Jama Connect?
Rush: We provide all of these examples and a rich set of resources for our customers to use and get a quicker and shorter time to value of their Jama Connect implementation. So we’re really excited about it.
Stroud: It sounds really exciting. So we touched a little bit earlier on the various subsegments within the semiconductor industry. So I’m assuming this solution is relevant regardless of where you sit in that supply chain. Is that true?
Rush: Yeah. You know, there are a couple of elements to it that are tuned to, like, EDA, IDM. They think of the IP block or IP core use case as really relevant to them. But also sort of, like, stepping back, if you’re just working on an alarm system for a machine that’s developing sort of the wafers for the the dye or a photolithography machine where you’re just generally sort of, you know, visualizing the product that you build in more of a systems capability, this is a really great starting point for all of those use cases. And then we can sort of tune it from there. EEA and IDM specifically, they have some unique aspects to it, so we give you a little bit of a preview. But Jama Connect, you know, right from the get-go, if I’m one of these other segments in sort of the manufacturing or fabrication space, I can just make a copy of this project, remove a couple of elements, and start working on day one.
Stroud: So it’s really scalable as well for those, as you say, IDM is a great example where they’re covering effectively multiple subsegments. It sounds like it was across those subsegments for them as well. So excellent.
So I think I understand the value to the engineer, you know, that it helps me to go faster. It helps me get up and running much quicker. I’m sure there’s more to it than that. But also, you know, what the relevance to the C-suite, you know, from a high-level perspective? Maybe you can talk about those two different personas and the value of each of those.
Rush: Sure. There’s quite a lot of crossover, but I would say, if I’m in the C-suite, I would identify risks earlier on in the process. So by giving you a consistent data model and some views of, like, what good looks like, we have some great views of really built-out sample data, using the rich traceability that’s part of these to give you a sort of at-a-glance view. What does a good Trace Score™ look like? What does a good Trace Score for a particular component mean? How do I identify risks where I have gaps in coverage?
I think those are gonna be really interesting to the C-suite as well as this framework. So getting everybody working in sort of a consistent, repeatable way, which then becomes reportable and can, you know, increase transparency for that C-suite to see sort of how exactly we are tracking, what the status of our marketing requirements is, how much testing we’ve done on our technical requirements or systems. At a glance, they can get into Jama Connect, see a couple of dashboard examples, and visualize right away how they can answer some of these really important questions.
Stroud: And then at the engineering level?
Rush: Yeah. I mean, a lot of people are just wondering how I get my job done within Jama Connect, and I think the procedure guide is just a perfect example. So if I am the owner of the MRD, you know, I have a lot of stakeholders that I have to get involved … how do I get that approved?
What are the steps to cascade that down to, like, the systems team that’s gonna write those first-order technical requirements? The procedure guide is like it’s it’s almost following it’s like following cooking instructions. Do this, do that, within Jama Connect to help build an approved work product, which I can then check into my document management system or leave or memorialize in a Jama Connect baseline. So I think those more detailed steps are gonna be really helpful for the engineers.
Stroud: Right. So I think it’s clear to me that this is a huge value and benefit to a new Jama Connect user. Is there relevance here for existing Jama Connect users as well, do you think?
Rush: Yeah. I think so. I mean, the solutions site that we put together, where this procedure guy is going to live, is going to have a lot of rich content. So we’re gonna have some curated marketing content, best practices, customer testimonials, things like this, as well as some best practice integration patterns. So if they’ve been wondering how to plug into Jira or a, like, a pre-silicon testing tool, there’s gonna be documentation on, like, you know, what the what that integration looks like and the best practices and use cases we support.
It’s always good to sort of, like, go back to the basics, I think, if you are a Jama Connect customer and you’ve been here for a few years. Like, very recently, I had a call with an EDA company, and they were talking about how to set up our system for IP reuse across most of these custom contexts that we’re gonna be building in the future. And, really, they’ve been sitting on the functionality the entire time, just haven’t had the vision on how to bring that all together, the procedures. And, actually, the procedure guide gives you sort of step-by-step examples on how to take these IP cores and reuse them into different project context. So I think there’s a lot of value for both the new customer and the existing customer.
Stroud: Excellent. So lots of value here. How do customers get hold of it?
Rush: Yeah. So if you’re not a Jama Connect customer yet, you can talk to your account executive. When you purchase Jama Connect, we will actually set you up with the instance. There’s going to be a cost associated with that, but it is something that we absolutely recommend. Shortens that time to value. Your configuration is really ready on day one. If you’re an existing Jama Software customer, you can talk to your customer success manager, and they can talk to you about sort of opting into this and getting you access to the solution space, which is gonna be part of the Jama Software community, as well as some of the templates that we’re developing.
Stroud: That’s great. So looking ahead, obviously, this is just the first release, the first instantiation. I’m assuming we’ve got a road map of features. We’ll continue to add and add more value as we go.
I know one of the hot topics in the industry, you know, in recent weeks and months, is around chiplets. I know that’s something we’re thinking about. So maybe you can talk a little bit about where we’re heading and what comes next.
Rush: Yeah. Yeah. That is on the docket. So chiplets are certainly on our mind. A system-on-chip management example is on my mind. I think that Jama Connect’s variant management, library, and reuse capabilities are really primed to help solve this problem. It’s just about developing some of that sample data and providing those examples that really resonate with the customer base. So that is something that is on the docket, and we’re gonna spend some time on it in the next couple of weeks here.
One-click data sheet generation. So, data sheet generation can usually be painful for those in the industry. So just giving you sort of, like, a very vanilla report that you can customize and tweak to put your branding on that will produce your data, in a data sheet format really nicely and beautifully. And then, industry-specific use cases, lab-on-chip, medical, and aerospace all have their unique flavors of certain things. They care about certain standards and regulations, and how we model Jama Connect will look a little bit different in each one of these use cases, so we’ll be tackling that as well.
Stroud: There is lots of goodness to come as well. So this has been a great conversation. I’ve learned a lot. Hopefully, our listeners have picked up on this great solution we’ve got coming out. Maybe you can just spend a moment to summarize what we’ve talked about and why this is a game changer for our customers.
Rush: Yep. So the new solution’s official launch date is December 2025. This is gonna include the new solutions site, which will have the procedure guide, some of that documentation on integration resources, and a few other aspects, as well as new templates tuned to the gem to the semiconductor industry that represent how you go from managing the high-level MRD all the way through post-silicon validation. So you’ll see that in a template example, and we’re really excited about where it goes next.
Stroud: Thanks, Steve, and thanks to all for watching. If you’d like to learn more about how Jama Connect can transform your semiconductor projects, visit our website at jamasoftware.com – If you’re already a Jama Software customer, your success manager or Jama Software consultant can provide additional insights. Together, we can drive innovation and build better outcomes.
Jama Connect® Features in Five: Industrial Machinery Development Solution
Streamline Industrial Machinery Development with Jama Connect!
In this Features in Five session, Patrick Garman, Solution Lead for Industrial Automation and Machinery at Jama Software, demonstrates how Jama Connect’s Industrial Machinery Data Model empowers teams to accelerate development and maximize project success in the industrial machinery space.
Key highlights include:
Purpose-built support for complex machinery, from robotic assembly cells to heavy equipment.
Centralized systems engineering with integrated safety, cybersecurity, risk management, and testing.
Tools for improving requirements quality, identifying gaps early, and ensuring seamless traceability.
Introduction to Industrial Machinery Data Model
Hi, everyone. I’m Patrick Garman, Solution Lead for Industrial Automation and Machinery at Jama Software. Today, I’ll introduce our industrial machinery data model and why it’s so powerful for teams building sophisticated machinery. Industrial machinery includes systems like robotic assembly cells, packaging equipment, elevators, and heavy machinery. Any automated system with software, safety, or network components.
Integration of Standards and Systems Engineering
These products must comply with a wide range of standards, and our data model integrates systems engineering, safety, cybersecurity, risk management, and testing into one structure in Jama Connect.
This gives your teams a head start so you can launch products faster without reinventing processes. With predefined structures, traceability models, and workflows, Jama Connect reduces rework and recalls by exposing gaps early. Centralized traceability helps teams respond to change confidently, measure progress, and identify risks before they become problems. At the core is our traceability information model, which enforces good engineering practices, prevents invalid links, and highlights gaps automatically. Let’s see how this works and looks in the tool.
First, here’s the project explorer tree. You’ll notice that it’s organized by product architecture as well as domain. This makes it easy for project members to quickly locate relevant data. And, of course, XAML is more than just a repository for requirements. We’re actively managing those requirements based on stakeholder review and feedback.
Utilizing Live Trace Explorer™ for Traceability
Next, let’s look at Live Trace Explorer. This gives a real-time view of traceability coverage across our project. We can immediately see what’s complete, what’s missing coverage, and so on.
Identifying Gaps in Coverage
This is really one of the biggest value drivers, knowing your gaps early before they turn into late-stage redesign. So let’s drill into one of these gaps right now. So I can see that I have just shy of seventeen percent coverage at the system level.
Using Trace View™ to Add Coverage
I can click that metric in the Live Trace Explorer diagram to open Trace View and find exactly where I need to add coverage. In Trace View, you can see that Jama Connect is prompting me to add coverage where required links are missing.
Creating and Managing Test Cases
And you can take action directly from this view to add that coverage, or we can open a specific requirement for a more detailed view. Here we have a system requirement with missing test coverage. I can author test cases directly in Jama Connect using the add related feature, or I can use Jama Connect Advisor™’s test case intelligence tool to generate suggested test cases, complete with test steps based on the context I provide. But of course, traceability doesn’t end with test coverage.
Jama Connect integrates directly with Jira to track development tasks. Jama Connect also has turnkey integrations for the most commonly used digital engineering and productivity tools. For example, I’m able to link my subsystem requirements to model elements in Simulink, again, with one click, links to the source artifacts. Pulling data from your digital thread into Jama Connect is not about duplicating work. Each team works in the tool fit for their purpose, and that work is reflected in Jama Connect for traceability and in context reporting. For teams managing product lines or customer-specific customizations, we can create catalog or library projects for reusable requirements.
Reusability and Component Management
With reuse, we can easily pull a reusable component and its related requirements into any project, and we can also use sync comparison to see which products a part or component is being leveraged in and how it may vary from what we have in our library. And that concludes our tour of the Industrial Machinery data model in Jama Connect. If you’d like a deeper dive or to learn more about Jama Connect Advisor and our live integration capabilities, please let us know.
How Digitization and Traceability Are Transforming Industrial Manufacturing
Modern industrial manufacturing undergoes frequent transformation as a result of technological innovations. Digitization and traceability have emerged as critical enablers that help manufacturers enhance operational efficiency, ensure regulatory compliance, and achieve sustainable growth in an increasingly competitive global market.
The integration of these processes (and technologies that support and enable them) represents more than a simple upgrade to existing systems. It reshapes how manufacturers approach
product development, quality control, and supply chain management. Companies that successfully implement digitization and traceability solutions position themselves to respond more effectively to market demands, reduce operational risks, and accelerate innovation cycles.
This comprehensive guide explores how digitization and traceability work together to create intelligent manufacturing ecosystems, the specific benefits they deliver, and the practical
considerations for successful implementation. We’ll examine real-world applications, address common challenges, and look ahead to emerging trends that will continue to shape the future of
industrial manufacturing.
For manufacturers ready to embark on this digital transformation journey, understanding these concepts and their strategic implications becomes essential for maintaining competitive
advantage and ensuring long-term success.
Understanding Digitization in Industrial Manufacturing
Digitization in manufacturing represents the systematic conversion of analog processes, systems, and data into digital formats that enable intelligent automation and data-driven decision making. This transformation extends beyond simple computerization to create interconnected networks of smart devices, systems, and processes that communicate seamlessly throughout the manufacturing ecosystem.
At its core, manufacturing digitization involves several key technological components working in harmony. AI-powered systems analyze vast amounts of production data to identify patterns,
predict equipment failures, and optimize manufacturing processes in real time. These intelligent systems learn from historical data and continuously improve their predictive capabilities, enabling manufacturers to make more informed decisions about production scheduling, resource allocation, and quality control measures.
Internet of Things (IoT) devices serve as the sensory network of digital manufacturing environments. Embedded sensors throughout production lines collect continuous streams of data on temperature, pressure, vibration, speed, and countless other operational parameters. This constant monitoring enables manufacturers to maintain optimal operating conditions and detect anomalies before they impact production quality or efficiency.
Real-time data analytics transforms the continuous flow of information from IoT sensors into actionable insights. Advanced analytics platforms process streaming data to identify trends, detect
deviations from normal operating parameters, and generate alerts that enable immediate corrective actions. This capability allows manufacturers to maintain consistent product quality while minimizing waste and downtime.
Cloud computing infrastructure provides the scalable foundation that supports these digital capabilities. Cloud platforms enable manufacturers to store and process massive datasets,
run complex analytical models, and provide secure access to critical information across global operations. The flexibility of cloud solutions allows companies to scale their digital capabilities as their operations grow and evolve.
These components work together to create a comprehensive digital ecosystem where every aspect of the manufacturing process generates valuable data. Production equipment communicates with
quality control systems, inventory management platforms share information with supply chain partners, and maintenance systems coordinate with production schedules to minimize disruption.
The result is a manufacturing environment that operates with improved visibility, control, and efficiency. Manufacturers can track individual products through every stage of production, monitor equipment health in real time, and adjust processes dynamically to meet changing demands or conditions.
The Role of Traceability in Modern Manufacturing
Traceability establishes the ability to track and document the complete history of a product, component, or process throughout its entire lifecycle. In manufacturing contexts, this capability
provides detailed records of materials, processes, quality checks, and handling procedures that enable manufacturers to verify product authenticity, identify sources of defects, and
demonstrate compliance with regulatory requirements.
The significance of traceability extends far beyond simple record-keeping. Enhanced supply chain transparency becomes possible when manufacturers can track components and materials
from their original sources through every transformation and handling step. This visibility enables better supplier relationships, more effective quality management, and faster response
to supply chain disruptions or quality issues.
Improved quality control represents another critical benefit of comprehensive traceability systems. When manufacturers can correlate product defects with specific batches of raw
materials, particular production runs, or individual pieces of equipment, they can implement targeted corrections that prevent similar issues from recurring. This capability reduces waste,
minimizes customer complaints, and protects brand reputation.
Better risk management becomes achievable through traceability systems that provide early warning of potential problems. When manufacturers can quickly identify which products might
be affected by a defective component or problematic production batch, they can take proactive measures to prevent widespread quality issues or safety concerns.
Regulatory compliance requirements across many industries mandate detailed traceability records. Pharmaceutical manufacturers must track ingredients and production processes to
ensure drug safety and efficacy. Food producers need comprehensive records to enable rapid response to contamination issues. Aerospace and automotive manufacturers require detailed
documentation to verify that components meet safety and performance standards.
Several key technologies enable comprehensive traceability in manufacturing environments. Blockchain technology provides immutable records of transactions and processes that create tamper-proof audit trails. Each step in the manufacturing process generates a blockchain entry that cannot be altered or deleted, providing absolute confidence in the accuracy and completeness of traceability records.
Radio Frequency Identification (RFID) systems enable automatic tracking of components, products, and equipment throughout manufacturing facilities. RFID tags attached to items provide unique identification that can be read automatically as products move through production processes, eliminating manual data entry errors and ensuring complete tracking coverage.
Advanced sensor technology continuously monitors environmental conditions, process parameters, and product characteristics throughout manufacturing operations. These sensors generate detailed records of the conditions under which products are manufactured, enabling manufacturers to correlate quality outcomes with specific environmental factors or process variables.
Benefits of Integrating Digitization and Traceability
The strategic integration of digitization and traceability technologies creates benefits that exceed what either approach can achieve independently. This combination enables manufacturers to build intelligent, responsive operations that adapt quickly to changing conditions while maintaining complete visibility into every aspect of their processes.
Enhanced Efficiency and Productivity
Digital traceability systems eliminate many manual data collection and recording tasks that traditionally consumed significant labor resources. Automated data capture through IoT sensors and RFID systems ensures complete and accurate records without requiring dedicated personnel for data entry or verification activities.
Predictive maintenance capabilities emerge when digitization platforms analyze traceability data to identify patterns that indicate impending equipment failures. By correlating equipment
performance data with maintenance records, manufacturers can schedule preventive maintenance activities during planned downtime periods, avoiding unexpected production interruptions.
Process optimization becomes more precise when manufacturers can analyze complete traceability records to identify the specific conditions and procedures that produce the highest quality outcomes. This analysis enables continuous improvement initiatives that incrementally enhance efficiency and product quality over time.
Improved Quality Control
Real-time quality monitoring becomes possible when digital systems continuously track product characteristics throughout manufacturing processes. Instead of relying on periodic sampling
and testing, manufacturers can monitor every product and immediately identify deviations from quality specifications.
Root cause analysis capabilities improve dramatically when comprehensive traceability records enable manufacturers to correlate quality issues with specific materials, processes, or environmental conditions. This detailed analysis capability reduces the time required to identify and correct quality problems.
Batch tracking and recall management become more efficient and accurate when digital systems maintain complete records of which specific materials and processes contributed to each finished product. If quality issues arise, manufacturers can quickly identify all affected products and take appropriate corrective actions.
Supply Chain Optimization
End-to-end visibility throughout complex supply chains becomes achievable when digitization and traceability systems extend beyond individual manufacturing facilities to include suppliers,
logistics providers, and distribution partners. This comprehensive visibility enables more effective coordination and planning across the entire supply network.
Demand forecasting accuracy improves when manufacturers have access to real-time data about inventory levels, production capacity, and customer demand patterns throughout their supply chains. This improved forecasting enables more efficient inventory management and production planning.
Supplier performance monitoring becomes more objective and comprehensive when digital systems track delivery performance, quality metrics, and compliance with specifications. This data-driven approach to supplier management enables better supplier relationships and more effective risk management.
Risk Mitigation and Compliance
Automated compliance documentation reduces the administrative burden of maintaining regulatory records while ensuring completeness and accuracy. Digital systems can automatically
generate the reports and documentation required by regulatory agencies, reducing compliance costs and eliminating the risk of incomplete or inaccurate submissions.
Proactive risk identification becomes possible when analytical systems monitor traceability data for patterns that indicate emerging risks. Early warning systems can alert manufacturers to
potential quality issues, supply chain disruptions, or compliance concerns before they impact operations or customers.
Audit trail integrity improves when blockchain and other tamper-proof technologies ensure that compliance records cannot be altered or deleted. This capability provides regulatory agencies
and customers with complete confidence in the accuracy and authenticity of compliance documentation.
Predictive Maintenance
Equipment health monitoring through continuous sensor data collection enables manufacturers to track the condition of critical production equipment and predict when maintenance activities
will be required. This capability reduces unplanned downtime and extends equipment life.
Maintenance scheduling optimization becomes possible when digital systems analyze equipment performance data, maintenance history, and production schedules to identify the optimal timing for preventive maintenance activities. This optimization minimizes production disruptions while ensuring equipment reliability.
Spare parts inventory management improves when predictive maintenance systems provide advance notice of which components will require replacement and when. This capability enables more efficient inventory management and reduces the risk of production delays due to parts shortages.
Sustainability Benefits
Energy consumption optimization becomes achievable when digital systems monitor and analyze energy usage patterns throughout manufacturing operations. This analysis enables manufacturers to identify opportunities to reduce energy consumption and carbon emissions while maintaining production efficiency.
Waste reduction initiatives become more effective when traceability systems provide detailed information about material usage, production yields, and waste generation. This data enables targeted improvements that minimize material waste and environmental impact.
Circular economy principles become more practical to implement when comprehensive traceability systems track materials and components throughout their entire lifecycles.
This visibility enables manufacturers to identify opportunities for recycling, reuse, and remanufacturing that reduce environmental impact and material costs.
We are excited to announce that Jama Connect 9.32 has set new scalability benchmarks five times greater than legacy systems. As products across industries become multi-disciplinary engineered product lines, the scale and complexity required to manage the product development process has grown dramatically. Jama Connect 9.32 scalability benchmarks:
Scale benchmarks for on-premise or SaaS deployments:
Items per project – 10 million
Items per instance – 100 million
Concurrent users – 10,000
These new scale benchmarks are five times greater than legacy systems’ published benchmarks. Companies across industries have been hamstrung by the inability of legacy systems to scale to the levels required by their engineering teams to speed time-to-market and deliver increasing levels of quality. Systems that cannot scale to 10 million project items and 100 million items per instance force enterprise engineering teams to artificially separate workstreams leading to defects, delays, cost overruns, recalls and warranty costs. Jama Connect is the only system that scales to the levels required.
Companies rely on Jama Connect for consistent and stable performance regardless of project or instance size and with today’s release of 9.32 this capability continues Jama Software’s unparalleled leadership in managing scale. As the only provider of a true multi-tenant SaaS offering, Jama Software provides companies with the ability to offload the burden and cost of hardware, hosting, upgrades and IT management that is required with legacy tool providers.
“The system architecture required to achieve these levels of scalability is foundationally different than current legacy systems,” said Jim Davidson, CTO Jama Software. “This is the result of two years of effort to incorporate the latest technologies and architecture for scalability.”
All Jama Connect customers will be seamlessly upgraded as part of the normal upgrade process.
Jama Connect 9.32 is available today.
Frequently Asked Questions about Jama Software
Q&A Q1: What is the best requirements management software for my industry or team size? A1: The suitability of requirements management software depends on factors such as regulatory demands, system complexity, and collaboration needs. Jama Connect is highly selected by teams in regulated and systems-engineering-heavy industries due to its focus on traceability and structured requirements management.
Q2: What scalability benchmarks has Jama Connect achieved for on-premise or SaaS deployments? A2: Jama Connect 9.32 has achieved the following scalability benchmarks:
Items per project: 10 million
Items per instance: 100 million
Concurrent users: 10,000
These benchmarks are five times greater than the largest known legacy system deployments.
Q3: How does Jama Connect compare to legacy systems in terms of scalability? A3: Jama Connect 9.32 outperforms legacy systems by scaling to 10 million items per project and 100 million items per instance. Legacy systems cannot store or perform at these levels, forcing enterprise engineering teams to separate workstreams, which can lead to defects, delays, cost overruns, recalls, and warranty costs.
Q4: How does Jama Connect support the increasing complexity of modern product development? A4: Jama Connect is designed to handle the growing scale and complexity of multi-engineered product lines. By providing scalability benchmarks of 10 million items per project and 100 million items per instance, it ensures that engineering teams can manage complex product development processes without needing to artificially separate workstreams, reducing the risk of defects, delays, and cost overruns.
Q5: How does requirements management software support scaling across multiple teams and programs?
A5: As organizations scale, requirements management software must support parallel development, standardized processes, and cross-program visibility. Tools like Jama Connect provide centralized requirement repositories and role-based workflows that help maintain consistency across distributed teams and initiatives.
Q6: What makes Jama Connect’s architecture suitable for complex use cases?
A6: Jama Connect’s architecture is built on the latest technologies specifically designed for scalability. This foundationally different system architecture enables it to support 10,000 concurrent users and manage billions of items and API calls in the cloud, making it ideal for complex, large-scale engineering projects across industries.
Q7: How does Jama Connect improve the quality of requirements? A7: Jama Connect improves the quality of requirements by leveraging natural language processing (NLP) through its AI-powered Jama Connect Advisor™. This tool provides guided authoring and multi-statement analysis to optimize the clarity, accuracy, and usability of requirements. It minimizes ambiguity and contradictions, which are responsible for 70-80% of rework costs, and aligns requirements with industry-leading standards like INCOSE Rules and EARS Notation.
Stop Scrambling for Submissions. Build Readiness Into Your Process With AI.
Regulatory submissions often become a stressful, last-minute rush, increasing risk, rework, and frustration. But what if you could embed submission readiness into your process from the start? Artificial Intelligence (AI) is making this a reality by connecting requirements, regulatory guidance, and ongoing monitoring seamlessly throughout the product lifecycle.
From Requirements to Regulatory: How AI Is Transforming Submission Readiness
Tom Rish: Thank you to everyone for being here today. We have a very exciting webinar about AI, a hot topic, of course, as always, and so I’m excited to dive into it. Before we do, I just want to talk very briefly about Jama Software and what we do. I know some of you have watched previous webinars, and you know all about this, but I want to give a high-level overview and talk just a little bit about how we are looking to incorporate AI to make your life easier when it comes to requirements management. So first, Jama Connect ®. As you all know, when it comes to launching a product, you have to keep track of all your requirements, all of your risk items, all of your testing, and everything like that. It can be a lot of work, especially on spreadsheets or disjointed systems, whatever it is you use.
And at Jama Software, what we’re trying to do is make it simple for you. We want you to focus on designing. We want you to focus on testing. We want you to focus on important things like the safety of the patient and not worry as much about paperwork and organizing everything. A lot of times, as you know, that’s done at the end, and it’s a checkbox activity. But we have a system, as you can see there on the left. I know many of you are used to a lot of documentation and everything. We want to bring that into a very organized V model that you’ve all seen there. Start with user needs. Enter those right into the system, build as you go. We can connect all of the systems you use, whether it’s software products, and you’re using a lot of things like Jira, GitHub, things like that, all your test systems, but we want to keep things organized.
Rish: What’s cool about Jama Connect is that we work with all industries, but we have frameworks specifically for medical devices. So out of the box, we’re able to build a framework where you can match it to your processes to track your user needs, design controls, risk management, and all of your tests. We have real-time collaboration so that you can do all of your reviews and comments in the software, create libraries, and release things. And finally, we have the AI guidance that I’m here to talk about today.
A couple of things here on this slide. This is mostly focused on requirements management. One of them is there today and available for use. Some of our customers are using it, and we’ve gotten some good feedback. Some of these here are things that are coming in the future. First thing that we have here today, though, is a scoring system. So when you enter your requirements into Jama Connect, we have AI that scans through INCOSE and EARS guidance and tells you how well this requirement is written. So it gives you a scoring system to tell you, “Hey, this one looks pretty good,” or, “This one doesn’t, and here’s why this is the rule or the guidance that it doesn’t quite meet.” So that’s ready to use today. I’ve talked to a few customers already who have said how helpful it has been for downstream operations like testing to create better testing and things like that.
We’re also working on some things where we will help rewrite requirements if needed. So not only does it give you scores, but help you rewrite them so that they can match the guidances better. So if you give it an initial draft of a requirement, we’ll go through, we’ll score it, but we’ll also give you some recommendations for changing it.
I think ideally everyone’s probably wondering how you just create them for us. So we are looking into some ways that we can enter some project inputs into the software, and then it will give you some requirements for you. So that will be in the future, along with PDF parsing. A lot of you come with existing documentation already. You might have requirements documents, software specification documents, things like that. We’re working on some AI features that will take those and create requirements automatically for you in the structure that they are.
Rish: A couple of other things. One thing that is new now, again, is test case generation. When you have your requirements in there, what we want to do is help you create good testing and guidance for creating the right acceptance criteria and things like that for your testing. Also, looking at an AI assistant, I think everyone is used to AI assistance these days, but a more conversational workflow where you can enter information into the software, and we’ll give you some guidance and feedback on that. Also, looking into ways that we can take your requirements and give you tips on how to link them together better, create better relationships, and finally help with reviews to detect areas that maybe are high risk.
I think later on, what we’re going to talk about is how the FDA and other regulatory bodies are starting to incorporate AI. So what we want to do is help you get it right up front so that when it’s sent over there, you feel good about everything. So that’s a little bit about Jama and how we’re using AI today. Now for the main event, I’m excited to pass it over to Adam. I met Adam at the MedTech conference in San Diego. And when I went up to his booth, I was instantly impressed. I think as a product development engineer, I spent a lot of time searching through the FDA databases.
And there are a lot of them, as I’m sure you all know, and there is excellent information in those databases. The challenging part is that it’s hard to go to each one every time and find what you need. The interfaces are a little outdated at times as well. You can find everything, but it’s just not easy. And what I always thought is, why can’t anybody scrape this information or pull this information and use it in a better format and make our lives easier? And that’s exactly what Adam and his team are doing. And so I’m excited to hand it over to him, and he will tell you more about Agent Astro and give some practical tips about how to better use AI throughout your process.
