Tag Archive for: Requirements & Requirements Management

Curious to learn how the Medical Device Framework in Jama Connect® can help streamline your compliance efforts and ensure your products meet necessary regulatory requirements?

During this informative session, Vincent Balgos, Director of Medical Device Solutions at Jama Software® discusses the latest solution offerings for Medical Device and Life Sciences in Jama Connect, including:

  • Updated Software as Medical Device (SaMD) framework incorporating readily available off-the-shelf elements for workflow and efficiency
  • Newly developed Research Use Only (RUO) and In-Vitro Diagnostics (IVD) frameworks
  • Refined solution enhancements, including new and updated report templates
  • Self-guided onboarding framework to assist new users in Jama Connect

Discover how Jama Connect can help you optimize compliance and regulatory processes, helping you stay ahead in the constantly evolving medical device industry.

Below is an abbreviated transcript and a recording of our webinar.

Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

Vincent Balgos: For today’s webinar, I’d like to talk about our updates to our Medical Device and Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today. The first one is really just kind of talking about general overview and general improvements in terms of risk, some new features that we’ve enabled with Jama Connect, but also some new and updated solutions such as Software as a Medical Device, Research Use Only, and our new self-guided onboarding framework.

So the intent of the update is to continually improve Jama solution to the medical device and life sciences industries based on a variety of factors, including new Jama Connect features and abilities that help streamline general product development processes and industry best practices. Also adapts to the ever-evolving regulations such as MDR, IVDR, and potential changes to the lab developed test area. We’ll talk about more of this in the ROU space. We’ve also included internal research and internal experience with over 80 years of industry experience from the internal Jama team. And lastly, we’ve also incorporated some feedback from customers like yourselves on best practices, innovative solutions, and new use cases. So thank you ahead of time and please continue to contribute via the Jama Community Ideation page or discussion with Jama folks.

These solutions that are presented are compatible and available with Jama Connect for both our cloud customers, both the standard and validated, and our self-hosted environments. Some highlighted features may require version updates, and this is really particular to our self-hosted customers with legacy versions.

RELATED: The Top 5 Challenges in Digital Health Solution Development

Balgos: So what I’d like to first talk about is the general organization and layout. So what I’m going to do is come back between screens, between the PowerPoint and the actual, the demo itself.

So the first thing I want to show is the general organization and layout of our new Medical Device Framework 2.0. The first thing I want to show is when we go ahead and take a look, you’ll see here in this new folder we have something enumerated Medical Device Framework 2.0, that actually has our new Medical Device Framework and our other additional popular framework such as SAMD and Consumables Framework.

The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our 300 plus customers and their practices using Jama Connect. We’ll deep dive into each one of these very shortly. We’ve also archived the current… sorry, the previous Medical Device Framework 1.0 for your reference only.

So now let’s go ahead and dive into the overview of the MDF 2.0. So I’m going to jump into the tool. And as you can see here right on the screen, we’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have. The most common example is associated with risk. So as many of you may know, not all risk controls are requirements. So we still need a way to trace to these non-requirement risk controls. These controls could be IFUs or instructions for use, training, labeling, or labeling and packaging, et cetera, and may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.

RELATED: Jama Connect® for Digital Health Solution Overview

Balgos: Another thing that we’ve done is actually updated our hazards library to include general hazards identified in 14971. As you can see here on the screen, we’ve now populated the general hazards identified in 14971 based on the information that you have. So you have pretty much a starting place with your hazard library that you have here.

The next item that I’d like to talk about is actually this new feature called the Risk Lookup Matrix. Available in 8.754, this features allows a new lookup matrix risk analysis approach that automatically outputs the desired content based on a pre-configured lookup table. This really aligns with 14971. Let me show you a quick demo of this because we’ve now implemented this as part of our Medical Device Framework 2.0.

RELATED: The Importance of Benefit-Risk Analysis in Medical Device Development

Balgos: As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of, again, follows the general 14971 schema of hazardous sequence of events, hazardous situations harmed. But here is now where we’ve implemented this new lookup matrix feature where now I’ve now identified the input pick lists where I may be able to change this, and then that automatically updates my risk level based off that matrix. So for example here, if I went ahead and increases the frequency and I increase my severity from here over here, and this one as well, I can see that both my P total and risk analysis has been updated per the lookup matrix. We have an additional features [inaudible 00:07:27] video that showcases a little bit more. So we definitely encourage you to look at that further.

The other thing that we wanted to share with particularly this medical device update is we have now included pre-configured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, what I mean by this is when I look at my item type, I’ve now included pre-configured DFMEAs, process FMEAs, and use FMEAs that you may configure based on your organization. This just allows for streamlining of your risk measures processing quickly to Jama Connect.

To watch the entire webinar, visit
Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®


G2 Summer Report

 

G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Summer 2023 Grid® Report

Thank You to Our Customers!

Jama Connect® was again named far above all others as the overall leader in the Summer 2023 G2 Grid Report for Requirements Management Software!

Alongside the honor of being named the only leader in requirements management software, we are proud to showcase that we were awarded several additional medals for Summer 2023 in both Requirements Management Software and Application Lifecycle Management (ALM) Software, including:

    • Users Love Us: For products that have collected 20 reviews with an average rating of 4.0 stars.
    • Enterprise Leader: For products rated highly by G2 users and have substantial Satisfaction and Market Presence scores
    • Momentum Leader: Products in the Leader tier in the Momentum Grid® rank in the top 25% of their category’s products by their users.
    • Easiest to Use: The product in the Usability Index earned the highest Ease of Admin rating in its category
    • Best Relationship: The Best Relationship product in the Relationship Index earned the highest Relationship rating in its category
    • Easiest To Do Business With: The Easiest Doing Business With product in the Relationship Index earned the highest Ease of Doing Business With rating in its category
    • Easiest Admin: For products that earn the highest Ease of Admin rating in their category
    • Best Usability: The Best Usability product in the Usability Index earned the highest Usability rating in its category
    • Fastest Implementation: For product that had the shortest go-live time in its category
    • Easiest Setup: The product that earned the highest Ease of Setup rating in its category
    • Users Most Likely to Recommend: The Users Most Likely to Recommend product in the Results Index earned the highest Likely to Recommend rating in its category

Download the full report to see why customers love using Jama Connect for product, systems, and software development.

Learn More About the Summer 2023 G2 Grid for the top Requirements Management Software products HERE!

DOWNLOAD

At Jama Software®, we’re proud to be recognized as the leader in requirements management software. We’re grateful to our customers for their invaluable feedback on their experiences using Jama Connect for requirements management. We remain committed to providing them with the expert knowledge, attention, and resources they need to help them achieve their goals.

The “Users Love Us” category, in particular, is a testament to the value our industry-leading requirements management software brings to our customers, and especially for customers who have moved from a document-based approach to complex product, systems, or software developement.

“Jama [Connect] is the final death blow to your grandfathers way of managing text based requirements.”

-From review collected and hosted on G2.com, Mark M. — Mid-Market

Read Jama Connect reviews on G2

We strive to provide our customers with the best experience while using our platform. Categories such as “Easiest to Use”, “Easiest Admin”, “Users Most Likely to Recommend”, and “Best Usability” in particular show how much our users enjoy working within Jama Connect.

“Product Design teams need a requirements management tool like Jama [Connect.] Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.”

-From review collected and hosted on G2.com, Verified User, Retail — Mid-Market

Review Jama Connect on G2

From all of us at Jama Software to all of you, thank you!

G2 scores products and sellers based on reviews, gathered from their user community, as well as data aggregated from online sources and social networks. Together, these scores are mapped on their proprietary G2 Grid®, which can be used to compare products, streamline the buying process, and quickly identify the best products based on the experiences of your peers.


Traceability Matrix

Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements

In this post, we cover the definition of a traceability matrix and discuss the limitations of using a trace matrix for requirements management and provide an alternate, superior option.

Trace matrices, also known as traceability matrices, are frequently used in complex product, system, and software development to keep track of the connections between specifications, design components, and test cases. They provide an organized way to make sure that the system’s planning, execution, and testing satisfy each requirement. When utilizing trace matrices in challenging development projects, however, it is important to consider a number of their known drawbacks.

Here are five key limitations of using a traditional traceability matrix for requirements management:

1. Limited Visibility: In projects with a lot of requirements and design components, trace matrices can grow significantly in size and complexity. As a result, it can be difficult for teams and stakeholders to get a comprehensive understanding of the complete system — and to understand how each requirement relates to the other components. This often results in mistakes and gaps in the trace matrix, which lowers the system’s quality and introduces risk to both the project and the product.

2. Maintenance Overhead: Trace matrices require constant maintenance throughout the development process. As new requirements are added or changed, the trace matrix needs to be updated to reflect these changes. This can be time-consuming and can take away from other important development tasks. Additionally, it can be challenging to keep track of every change, which can result in mistakes in the trace matrix.

3. Limited Scope: Trace matrices are typically limited to the scope of the specific project they were designed for. They are insufficient for tracing issues that span across various disciplines, such as security or efficiency, which may require a different, more robust, traceability strategy. Additionally, trace matrices might not fully account for a system’s complexity, such as sudden changes or relationships between components, which can result in unforeseen issues.

4. Lack of Context: Trace matrices only provide a static view of the system and do not capture the dynamic context in which the system operates. For example, a requirement may be met by a design element, but the design element may have unintended consequences when combined with other elements in the system. Trace matrices may not capture these interactions, which can lead to bugs or other issues in the final system.

5. Limited Support for Agile Development: Trace matrices are typically associated with traditional, waterfall-style development processes, which do not align well with Agile development methodologies. Agile development processes emphasize collaboration, iterative development, and quick feedback cycles, which can be difficult to reconcile with the strict traceability requirements of a trace matrix. As a result, trace matrices may not be well-suited for Agile development projects.

RELATED: The Jama Software® Guide to Requirements Traceability

Five Advantages of Using a Robust Requirements Management and Traceability Solution, Like Jama Connect®, Over a Static Traceability Matrix

Jama Connect®’s powerful, yet easy-to-use, requirements management and traceability platform bring people and data together in one place, providing visibility and actionable insight into the complete product development lifecycle. Teams and stakeholders — regardless of their location — can easily share updates in seconds, discover issues weeks sooner, and have one place to collaborate with key stakeholders — in real time. As a result, Jama Connect offers many advantages over using a traditional traceability matrix.

Here are five advantages of Jama Connect:

1. Automation: Jama Connect automates many tasks that would be tedious and time-consuming to do manually. For example, it can automatically generate traceability matrices, link requirements to test cases, and track changes to requirements. And, because testing is built into Jama Connect, users can take advantage of our trace view to navigate from high level requirements, all the way down to test cases and defects. This allows users to view any failed tests or open defects that are associated with their upstream requirements. Because traditional trace matrices are static, they are unable to benefit from this type of automation.

2. Visibility: Jama Connect provides a more comprehensive view of the requirements and their relationships than a static traceability matrix by automatically generating Live Traceability™ which allows you to navigate levels of traceability both upstream AND downstream. With Jama Connect, you can see the entire requirements hierarchy, including parent-child relationships, dependencies, and impact analysis.

3. Collaboration: Jama Connect makes it easy for teams to collaborate on requirements. With features like comments, reviews, and notifications, team members and stakeholders can discuss and iterate on requirements in real-time.

4: Customization: Jama Connect is highly customizable, allowing it to be tailored to your specific needs. You can create custom fields, workflows, and reports to match your organization’s processes and requirements.

5. Scalability: Jama Connect is designed to handle large and complex projects with thousands of requirements. It can support multiple teams, projects, and stakeholders, and can integrate with other best-of-breed tools in your ecosystem.

Additionally, with Jama Connect, teams can implement live requirements traceability and measure it to continuously improve end-to-end systems development process performance, even through siloed development, test, and risk activities.

RELATED: Requirements Traceability: Links in the Requirements Chain

What is Live Traceability™?

Live requirements traceability is the ability for any engineer at any time to see the most up to date and complete upstream and downstream information for any requirement—no matter the stage of systems development or how many siloed tools and teams it spans. This enables the engineering process to be managed through data, and its performance improved in real time.

Conclusion

Even though trace matrices can be a helpful tool for keeping track of requirements, design components, and test cases in some development projects, there are several drawbacks to be cognizant of, especially as projects become increasingly complex. These limitations include limited visibility, lack of context, narrow scope, maintenance overhead, and inadequate support for Agile development. So, it might be time to consider other, more modern, and robust approaches to traceability for complex product, systems, and software development projects.

Jama Connect, the leading requirements management and proven traceability software platform, enables a digital thread that ties tools and metadata together across the end-to-end product lifecycle. This provides real-time insights that allow for streamlined product development that is less prone to overall risk, rework, or recalls. Overall, Jama Connect offers more automation, visibility, collaboration, customization, and scalability than a traditional traceability matrix — and provides a more modern and efficient way of managing requirements in complex product, system, and software development.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Karrie Sundbom and Mario Maldari.


Digital Thread

In this blog, we recap the “New Research Findings: The Impact of Live Traceability™ on the Digital Thread” webinar.

Examine new industry research that highlights the reasons for the growing interest in digital thread and learn how Live Traceability™ enables the digital thread to reduce risk, save cycle time, and improve product quality.
The digital thread is a measurable data-driven architecture that links together information generated from across the product lifecycle and is envisioned to be the primary or authoritative data and communication platform for a company’s products at any instance of time.

During this session, James Roche, Practice Director of Aerospace & Defense at CIMdata, Inc and Cary Bryczek, Director of Aerospace & Defense Solutions at Jama Software®, report on key findings from recent research on digital thread conducted by CIMdata on behalf of the Aerospace and Defense PLM Action Group — and in collaboration with Jama Software and other solution providers. The shared objective of this research was to gain an understanding of the needs and opportunities within industry that will inform digital thread solution strategies and roadmaps and guide industrial implementations.

Finally, learn how Jama Software’s industry-leading platform, Jama Connect®, helps teams manage requirements with Live Traceability across the systems development process for proven cycle time reduction and quality improvement.

Below is an abbreviated transcript and a recording of our webinar.

New Research Findings: The Impact of Live Traceability™ on the Digital Thread

James Roche: Thank you to Jama Software for inviting me to participate in today’s discussion of the exciting and important topic of digital thread. In this presentation, we’ll report key findings from recent research on the topic of digital thread conducted by CIMdata on behalf of the aerospace and defense PLM action group member companies in collaboration with Jama Software and other PLM solution providers. We’ll begin with an introduction of how this research came about, who sponsored it, and for what purpose. We’ll explain how the information was gathered and from whom. Then we’ll review the key findings from the research in various categories as shown here, the what and why of the digital thread, the current reality, planning future investments, and solution capability and provider alignment with the needs and strategies of their industrial customers.

I will then turn the session over to my colleague from Jama Software, Cary Bryzcek. The initiators and prime sponsors of this research are seven A&D OEMs who are the current members of the Aerospace and Defense PLM Action Group. Since its founding in 2014, the A&D PLM Action Group has sponsored research and jointly staffed projects on topics such as model-based definition, multiple-view bill of materials, PLM technology obsolescence management, global collaboration, model-based system engineering, and digital twin digital thread. The members regularly interact with the principal PLM solution providers in project collaborations and executive level strategic discussions.

RELATED: Jama Connect® for Air, Land, Sea, and Space Datasheet

Roche: The group’s leadership has recently determined to expand its reach into the PLM solution provider community, and engage in collaborative research and dialogue on strategic topics. The topic selected for this program was digital thread. We know that investment in digital thread today is real and substantial, and the level of investment will continue to rise. That reality positions digital thread as an emerging strategic opportunity within the PLM ecosystem. To invest effectively in solution development as a software provider, or solution implementation as an industrial user requires insight into current state enablers and barriers and future investment drivers.

The shared objective of this research was to gain understanding of needs and opportunities within industry that will inform digital thread solution strategy and roadmap, and guide industrial implementations. The project used two methods of gathering information, subject matter expert interviews and an online survey. Interviews were conducted by CIMdata with three communities, the participating solution providers, key A&D customers nominated by the participating sponsors, and the A&D action group member companies. The second method of information gathering was through a web-based survey targeted toward a broader community beyond practitioners in industry. The learnings from the interviews were applied to develop the line of inquiry for the web-based survey.

RELATED: Extending Live Traceability™ to Product Lifecycle Management (PLM) with Jama Connect®

Roche: CIMdata conducted a total of 15 interviews, five with the solution provider sponsors, five with their key customers, and five with A&D action group members. A total of 90 complete and validated survey responses were received and have been analyzed. Review of the names of the companies represented and the positions held by the interviewees and survey respondents confirms that the information received is representative of the most influential companies and leading thinkers within the aerospace and defense industry. The survey was open to all industries, but it was targeted toward and most heavily promoted within aerospace and defense, and nearly 60% of responses were from that industry. The response distribution was evenly spread across companies’ size by revenue.

We began our interviews and the survey with an exploration of the what and the why of digital thread. The conceptual understanding of digital thread within industry is very immature. All interviews began with a question, “What is your definition of digital thread,” which yielded 15 different definitions. Nearly half of the company’s survey do not have a commonly accepted definition of digital thread, and less than 10% use the published definition. Our search for the reasons for digital thread’s rise to prominence revealed the traditional drivers such as product complexity, time to market and search for efficiencies are clearly still in play, but new realities such as rising customer expectations as evidenced in the DOD’s digital engineering strategy with an authoritative source of truth, and new enabling technologies are major drivers of the digital thread’s rise to prominence.

Among specialists, there is a broad shared perception of what digital thread does, and what a digital thread is. The most prominent characteristic of what a digital thread is and what it does relate to establishing linkages and traceability between product data. Interestingly, if you combine the most prominent characteristics of what a digital thread does, you have a reasonable definition of the digital thread, establishes traceability of product information across multiple domains in the lifecycle, mechanical, electrical or electronic software and firmware to provide meaningful relationship connections between a product’s digital assets. Our research examined the current and expanding digital thread value footprint in three dimensions, program stage, data, and use cases.

To watch the entire webinar, visit
New Research Findings: The Impact of Live Traceability™ on the Digital Thread


FMEDA

Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

As a product development team working in the medical device sector, assuring the dependability and safety of your products is crucial. FMEDA, or failure modes, effects, and diagnostic analysis, is a method frequently used to assess potential failure modes and their consequences on the entire system.

What is FMEDA?

FMEDA is a rigorous and structured analysis technique used to predict the potential failure rates, failure modes, diagnostic capabilities, and their impact on a system or product. It is a quantitative approach that helps in understanding the failure rates and probabilities of different components, the suitability of the diagnostic functions of the design for subsystems of a product.

FMEDA is an essential step in the product development process since it aids in the detection of probable faults and their effects on the performance of the system as a whole. It also evaluates the potential efficacy of the implemented diagnostic functions in the subsystem or product design. It is used to assess a product’s dependability and safety and aids in the detection of any possible system failures.

FMEDA is frequently applied to complicated systems with numerous components and subsystems. It is commonly used in the medical device sector to assess the product’s safety characteristics, and to confirm that the design is suitable and safe to be used in the medical device industry.

RELATED: Why it Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System

How does FMEDA work?

There are various steps in the FMEDA process. The system or the subsystem is first divided into all of its component designs. The impact of each failure mode on the safety related functions of the design, as well as the diagnostic functionality coverage to identify the failure modes and to prevent occurring those, are then taken into consideration while evaluating the safety characteristics of the system or subsystem design.

The severity, frequency, and detectability of the failure modes are all taken into account while rating them. The impact of the failure on the system’s or product’s overall performance is referred to as severity. The terms “occurrence” and “detectability” describe the possibility that a failure will occur and the capacity to identify the failure mechanism, respectively.

Based on the system’s capacity to identify the failure mechanism and take appropriate action to lessen the effects of the failure, the diagnostic coverage is assessed.

The data is then utilized to determine the system or product’s overall failure rate and probability after each component’s failure modes, their consequences, and diagnostic coverage have been assessed for each one.

What makes FMEDA crucial?

FMEDA is significant for a number of reasons. It is beneficial to first recognize probable failure modes and how they may affect a system or product. The evaluation of the efficiency and suitability of the diagnostic coverage of the design provides further insights for developers on system or product safety. This information is essential for identifying any hazards the product can have and making sure it complies with all applicable regulations.

Secondly, FMEDA contributes to ensuring the product’s dependability and safety. Product development teams can take the necessary steps to reduce the consequences of probable failure modes and enhance the product’s overall performance and dependability by identifying potential failure modes and assessing their influence on the system or product.

Finally, FMEDA decreases the overall cost of product development. Early in the development process, teams can identify potential failure modes and take the necessary steps to mitigate those failures before they become significantly more expensive and time-consuming to fix.

RELATED: Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety

Conclusion

The bottom line is, FMEDA is a crucial step in the creation of new products for the medical device sector. It helps organizations ensure product’s safety and dependability, the identification of probable failure modes and their effects on the system or product, and the reduction of the overall cost of the product development process.

Understanding the FMEDA method and how it’s applied to improve the safety and dependability of your products is crucial for the product development team. You can make sure that your products comply with regulations, are trustworthy and safe, and satisfy the demands of your customers by incorporating FMEDA into the development process.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by McKenzie Jonsson and Vincent Balgos.


REST API

Jama Software® Announces Massive Adoption of Jama Connect®‘s API

Cloud API service requests exceed 600 million per month

Jama Software®, the industry-leading requirements management and traceability solution provider, announced that usage of its market-leading REST API is now exceeding 600 million cloud service requests per month. This rapid adoption reflects the rapid adoption of Jama Connect® as organizations achieve Live Traceability™ across best-of-breed tools within the engineering function.

Live Traceability throughout the engineering process requires automated synchronization across best-of-breed tools. Jama Connect’s REST API is the most mature, secure, and scalable API for requirements management and traceability solutions:

  • The only SOC 2 Type 2 certified REST API in the requirements management space.
  • The only multi-tenant, cloud-architected requirements management software that can handle the scale of over 600 million API cloud service requests per month and over 100,000 trailing 90-day active users.
  • The richest REST API with over 200 separate API functions spanning all objects, including; projects, requirements, baselines, comments, test plans, tags, attachments, and more.

“Live Traceability requires automated synchronization across best-of-breed tools, and our REST API is the only API that can enable Live Traceability at scale.”

Josh Turpen, Chief Product Officer at Jama Software

In addition to enabling Live Traceability, Jama Connect’s REST API also enables customers to gather test results from disparate tools, ensure that the entire organization is working from a single source of truth, and communicate across their supply chains in an automated fashion.

To Learn More, Visit: Getting Started with Jama Connect REST API

About Jama Software

Jama Software is focused on maximizing innovation success. Numerous firsts for humanity in fields such as fuel cells, electrification, space, autonomous vehicles, surgical robotics, and more all rely on Jama Connect® to minimize the risk of product failure, delays, cost overruns, compliance gaps, defects, and rework. Jama Connect uniquely creates Live Traceability™ through siloed development, test, and risk activities to provide end-to-end compliance, risk mitigation, and process improvement. Our rapidly growing customer base of more than 12.5 million users across 30 countries spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, financial services, and insurance industries. For more information about Jama Connect services, please visit www-dev.jamasoftware.com

Read the official press release here:
Jama Software® Announces Massive Adoption of Jama Connect®’s API

What is DOORS


What Are DO-178C and ED-12C?

What Are DO-178C and ED-12C?

Safety is the top priority in the aviation industry. Whether it’s a civilian plane, a military jet, or an uncrewed aerial vehicle, the reliability and integrity of onboard software are essential to guaranteeing safe and secure operations. This blog will look at the importance of DO-178C (and its EASA equivalent ED-12C, henceforth DO-178C), the sector it affects, and the mechanisms it uses to demonstrate compliance.

The Aviation Industry and its Unique Challenges

The aviation business has complex systems, cutting-edge technologies, and strict safety regulations. Software tools are essential to use during the design and development of these systems. A systematic approach to software development and verification is mandated by the regulatory bodies such as FAA and EASA given the rising reliance on software and the potential risks it poses. Here, DO-178C enters the picture.

What is DO-178C?

The DO-178C, also known as “Software Considerations in Airborne Systems and Equipment Certification,” is a standard that was released by the RTCA (Radio Technical Commission for Aeronautics). It outlines the goals and methods for creating the software used in airborne systems. By outlining the procedures, actions, and artifacts required for compliance, DO-178C offers a formal framework for guaranteeing airborne software’s security, dependability, and maintainability.

DO-178C Compliance

The primary objective of DO-178C is to ensure that software used in airborne systems functions as intended and does not pose any safety risks. The compliance process encompasses all aspects of software development, from planning and requirements to coding, testing, configuration management, and verification. Compliance levels, also referred to as Software Levels (DAL A, B, C, and D), are determined based on the significance of the software’s function, as well as the size, complexity, and functionality of the code. The higher the DAL level, the more rigorous controls are required from software developers. And as you might expect, a DAL A system will cost a lot more time and money to produce based on the development constraints and evidence one must produce for certification.

RELATED: A Nod To MOSA: Deeper Documenting of Architectures May Have Prevented Proposal Loss

Key Components of DO-178C

  • Software Planning: In this preliminary stage, plans for the development and verification of software, including its traceability, resources, and timetables, are defined. This lays the groundwork for the succeeding steps.
  • Software Requirements: To make reliable software, you need clear, precise requirements. This is emphasized by DO-178C, which requires that a software requirement is traceable to a higher-level system requirement, its SW function, its verification cases, as well as the code.
  • Software Design: The design phase makes an architectural plan to do what the specifications say. To make sure it does that, you use procedures, models, and reviews.
  • Software Implementation: During this phase, the software is coded and documentation produced, including standards, instructions, and test cases. This is required by the DO-178C standard and has code reviews and coding standards to reduce errors.
  • Software Verification: Verification activities, like unit testing, integration testing, and system testing, are needed to make sure the software meets expectations and criteria. Functional and structural coverage analysis must be included depending on the DAL level Also, depending on the DAL level, one must show independence. This means that the person that writes a requirement must be different than the person that reviews the requirement. The person that writes the software code must be different than the person that tests that code.
  • Configuration Management: DO-178C focuses on configuration management to make sure changes to software are monitored, tracked, and documented throughout development.

Benefits and Impact

The aviation industry gains many advantages by following DO-178C. By adhering to these strict criteria, organizations can ensure they are following the processes called out in the regulations and that they are meeting the highest standards of aviation development safety:

  • Enhanced Safety: By focusing on safety, DO-178C reduces the chance of problems caused by software.
  • Regulatory Compliance: The Federal Aviation Administration (FAA) and European Union Aviation Safety Agency (EASA) recognize DO-178C as an acceptable means of compliance for software safety, as a condition of issuing an airworthiness certification.

RELATED: Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety

How Can Jama Connect® Help?

Jama Connect®‘s digital engineering strategy is absolutely essential for any organization looking to boost efficiency and dependability. This strategy serves as a critical link between teams and optimizes design and engineering processes. With its comprehensive perspective of the entire system and reliable source of information, it’s an indispensable tool for success.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Cary Bryczek.


Live Traceability

This Features in Five video demonstrates how Jama Connect helps maintain Live Traceability across applications.

Jama Connect® Features in Five: Live Traceability™

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 the powerful features in Jama Connect®… in under five minutes.

In this Features in Five video, Jama Software® subject matter experts Neil Bjorklund, Sales Manager – Medical, and Steven Pink, Senior Solutions Architect, will demonstrate how Jama Connect helps maintain Live Traceability™ across applications.

VIDEO TRANSCRIPT:

Neil Bjorklund: So, what we wanted to do today is give you all a quick snapshot of what it looks like for Jama to be integrated across systems, and showing how Jama helps you all maintain Live Traceability across applications or what we call a connected digital thread.

As part of our demonstration today, we’re going to show you what that looks like across your V-Model here of system engineering, in which case we’re going to actually make a change from a Windchill item, so an item over in Windchill, making a change to a specification or a part over there. We’re going to trace from that Windchill item over to Jama at the subsystem design output level. So, you’ll be able to see those items synchronized across those applications. We’re then going to perform an Impact Analysis within Jama. So, that’s going to allow you to then visualize, if you were to make a change to a Windchill item, what impact does that have across your full system.

So, we’re going to then see that change cascade up to a system requirement level here. We’re going to then make a change to that system requirement, and Jama is going to have the suspect linking mechanism to be able to then identify what all items downstream could be impacted by this change. In which case, we’re going to show an example where a software requirement must be changed. We’re going to make that change, and we’re going to show that change and then cascade over into Jira.

RELATED: How to Use Requirements Management as an Anchor to Establish Live Traceability in Systems Engineering

Bjorklund: So, the idea here is that, by managing Live Traceability within Jama, maintaining Jama as integrated with other applications or ecosystems, you’re going to be able to visualize that connected digital thread and see changes take place from Windchill into Jama, over then into Jira.

Now, one thing to remember, this integration is very flexible. So, we can integrate from Jama over to Windchill PLM parts, problem reports, change requests, requirements, different folder structures, and so forth. Within the software side, obviously, we’re integrating with Jira, that’s very flexible. But, we can also integrate with other applications like Azure DevOps, PFS, things like that. So, again, this is just one example, just to highlight the flexibility here of Jama, and this workflow.

Steven Pink: Okay, so thank you, Neil, for that. Now, we’re taking a look at a spec here in Windchill. This is what we’re going to be making a change to today. I’m going to go ahead and make an edit to this, and this is what’s going to synchronize across into Jama. So, I’m going to update the description, update the specification within Windchill. We’ve now saved this update within Windchill. We’ve updated the description here, and this is going to synchronize across to Jama in real-time. So, I’m going to switch over to this speck from Windchill that has synced into Jama. I’ll refresh it here, and we’ll see the description has now updated in real-time. If we want to understand the impact this change could potentially have, we’ll use Jama’s Impact Analysis feature. This will allow us to look up and downstream from this specification.

So, based on those relationship rules Neil showed earlier in that Live Traceability in Jama, we can look from a spec, one of these subsystem design outputs, all the way upstream through hardware and software to those higher level system requirements to understand what the potential impact could be. So, I’ll go ahead and run this Impact Analysis. We’ll take a look, and it’ll find everything that’s directly and indirectly connected to this specification from Windchill.

RELATED: How to Use Requirements Management as an Anchor to Establish Live Traceability in Systems Engineering

Pink: We can see hardware requirements, the system requirement, a high-level user need, and maybe the system requirement is impacted by our change. We can click into the system requirement. If we need to make an update to this impacted system requirement, we can come in and modify the description here.

When I save this system requirement, Jama is actually going to identify everything downstream that has been impacted through the Suspect Link feature. So now, we’re flagging these downstream hardware and software requirements that could be impacted by the change we made to this higher-level system requirement. If there’s been an impact to this software requirement, for example, I can click into this software requirement. I can then edit the description to reflect the necessary updates based on that impact assessment.

And now, when I save this software requirement, this has been synchronized with Jira, so we’ll be able to see the updated software requirement updated into Jira in real-time. So, I’m going to switch over to Jira here, and this is that software requirement that we’re synchronizing. And now, we can see the update to that description has synced across to Jira in real-time, providing us Live Traceability between specifications in Windchill, through our requirements in Jama, all the way down through the lower level software and development work occurring in Jira.

RELATED: G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Spring 2023 Grid® Report

Bjorklund: Okay, thank you, Steven, for that. So, this is a quick recap. So, we’ve gone from a item in Windchill. We made that change within Windchill. That change was automatically reflected over into Jama. We then performed Impact Analysis within Jama, made changes across our system-level requirements, which then cascaded changes down into our software requirements over in Jira. Now, again, this is just one example where we’ve taken a change, we’ve integrated Jama with different applications, but Jama has the ability to integrate with all the applications across your product development lifecycle, across that V-Model system engineering.

So, if there are groups that are maybe not using Jira, you’d certainly have the ability to then manage change across different applications and, Jama serves as that central system to be able to manage Live Traceability and maintain that connected digital thread. Thank you.

To view more Jama Connect Features in Five topics, visit: Jama Connect Features in Five Video Series


G2

 

G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Spring 2023 Grid® Report

Thank You to Our Customers!

Jama Connect® was again named far above all others as the standout leader in the Spring 2023 G2 Grid Report for Requirements Management Software!

In addition to the honor of being named the standout leader in requirements management software (for both Mid-Market and Enterprise), we are proud to showcase that we were awarded the Users Most Likely to Recommend badge as well as several additional medals for Spring 2023, including:

  • Users Most Likely to Recommend: Earned the highest rating among other solutions in this category.
  • Users Love Us: For products that have collected 20 reviews with an average rating of 4.0 stars.
  • Fastest Implementation: For products that had the shortest go-live time in its category.
  • Easiest Setup: The product that earned the highest Ease of Setup rating in its category.
  • Easiest to Use: The product in the Usability Index earned the highest Ease of Admin rating in its category.
  • Easiest Admin: For products that earn the highest Ease of Admin rating in their category.
  • Momentum Leader: Products in the Leader tier in the Momentum Grid® rank in the top 25% of their category’s products by their users.
  • Enterprise Leader: For products rated highly by G2 users and have substantial Satisfaction and Market Presence scores.

Download the full report to see why customers love using Jama Connect for product, systems, and software development.

Learn More About the Spring 2023 G2 Grid for the top Requirements Management Software products HERE!

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We live vicariously through the successes of our customers. The “Users Love Us” category, in particular, is a testament to our commitment to our customers.

At Jama Software®, we’re proud to be recognized as the leader in requirements management software. We’re grateful to our customers for their invaluable feedback on their experiences using Jama Connect for requirements management. We remain committed to providing them with the expert knowledge, attention, and resources they need to help them achieve their goals.

“Powerful tool that makes traceability easy. I’ve found Jama Connect to be a great platform for managing my project requirements. It has a simple user interface but also allows for a lot of customization for my own company’s needs. I work in the medical device industry and find this software essential for tracking our internal requirements as well as external regulatory requirements.”

-From review collected and hosted on G2.com, Andrew P, Lead Product Engineer – Systems and Usability – Small Business

Read Jama Connect reviews on G2

We strive to provide our customers with the best level of service possible, and we look forward to supporting them with our expertise.

“I’ve been satisfied with Jama for years. Everything just works. The administrative tools are flexible and allow configuration to match our team’s workflow. It has highly configurable reports to allow us to export data for use in our document control system..”

-From review collected and hosted on G2.com, Allan P., Principal Test Engineer – Enterprise

Review Jama Connect on G2

From all of us at Jama Software to all of you, thank you!

G2 scores products and sellers based on reviews, gathered from their user community, as well as data aggregated from online sources and social networks. Together, these scores are mapped on their proprietary G2 Grid®, which can be used to compare products, streamline the buying process, and quickly identify the best products based on the experiences of your peers.


TMF

What is a Trial Master File in the Medical Device Industry?

A Trial Master File, also known as a TMF, is a collection of records and documentation about the creation, evaluation, and regulatory approval of a medical device. It shows the quality control procedures used in the device’s design, production, and testing to make sure it meets all applicable regulations. Regulators look at the TMF during inspections and audits to see if the device is in compliance.

How is a Clinical Trial Master File (TMF) similar to a Trial Master File?

A Clinical Trial Master File (TMF) is similar to a Trial Master File in that they are both collections of documents and records related to a specific project. However, while a Trial Master File pertains to the development, testing, and regulatory approval of a medical device, a Clinical Trial Master File pertains to the clinical trials conducted to evaluate the safety and efficacy of a medical device, pharmaceutical product, or treatment.

Both types of TMFs provide evidence of the processes and procedures used during the development and testing phases, and both are subject to review by regulatory agencies during inspections and audits.

What is an Electronic Trial Master File?

An Electronic Trial Master File (eTMF) is an electronic version of TMF that stores documents and records generated during the clinical trial process. eTMFs can replace paper-based TMFs and provide a more efficient and effective way to manage the vast amount of information generated during a clinical trial. Using an eTMF is becoming more common in the clinical trial industry due to its many benefits over paper-based TMFs, including improved efficiency, increased security and accessibility, and enhanced regulatory compliance.

To achieve compliance, organizations need defined processes for development and production and detailed traceability, from the high-level user needs through to test management. Documentation is a large part of proving compliance, and Jama Connect® makes it easy to compile the necessary documentation, like eTMFs. By automating the process, teams can focus on what’s important and avoid potential errors.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

What types of regulations are TMFs or eTMFs expected to meet?

Both Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF) must adhere to various regulatory requirements depending on the jurisdiction in which the clinical trial is conducted. Some of the common regulations that a TMF or eTMF must comply with include:

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines: This is a set of global guidelines for the development, registration, and post-approval of pharmaceuticals.
  • Good Clinical Practice (GCP) guidelines: This is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects.
  • The Food and Drug Administration (FDA) 21 CFR Part 11: This is a regulation that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
  • Health Insurance Portability and Accountability Act (HIPAA): This is a US federal law that requires the protection and confidential handling of personal health information (PHI) stored in electronic form.
  • European Union Clinical Trials Regulation (EU CTR): This is a regulation that governs the conduct of clinical trials in the European Union and aims to harmonize the regulatory requirements across EU Member States.

How can a TMF help an organization with successful product development and management?

It is important for the trial sponsor, sponsor’s representative or the CRO to ensure that the TMF or eTMF meets all relevant regulatory requirements to ensure the integrity and quality of the clinical trial data.

A Clinical Trial Master File (TMF) can help an organization with successful product management by providing a centralized repository of all the relevant documentation and information related to the development and testing of a product. The TMF helps to ensure that all necessary documentation is captured and easily accessible, which can help to:

  • Streamline the development process
  • Ensure regulatory compliance
  • Improve collaboration and communication
  • Facilitate post-market monitoring

RELATED: [Webinar Recap] An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR)

Overall, a well-managed TMF can play a critical role in the successful development, testing, and management of a product, by providing a comprehensive and centralized record of all relevant information and documentation.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson, McKenzie Jonsson, and Vincent Balgos.