Tag Archive for: Jama Connect Platform

Digital Thread

In this blog, we preview a section from the new eBook, “CIMdata: Digital Thread in Aerospace and Defense”
Click HERE to download it.

Recent CIMdata research on behalf of the Aerospace and Defense PLM Action Group member companies in collaboration with PTC clearly indicates that digital thread investment within the ecosystem of industrial users, their customers, suppliers, and solution providers is poised for rapid growth. Initial implementations of targeted digital thread solutions have provided proof points of value and essential learnings. Now, rounds of investment are ramping up, guided by these early achievements and with expectations driven by the value potential revealed.

The concept of a digital thread providing automated linkage of multiple representations of a product, each tuned to the needs of various creators and consumers along the lifecycle, is very powerful. Until recently, tracing these linkages has been primarily a manual process, extracting product information from myriad heterogeneous systems and relating them in ad hoc reports. But now, with recent advances in commercial PLM solutions, the digital thread, with automated linkages and traceability, has become a practical possibility, even for industries with complex products, such as aerospace & defense.

In response, industry leaders have implemented targeted digital thread solutions and envision expanding these solutions throughout the product lifecycle. With the newness of this approach there is not much available in the way of lessons learned or value achieved. This lack of real data is a barrier to broader investment within industry. On the solution side, providers are constantly seeking additional insight into investment drivers within industry.

Future Digital Thread Investment Priorities

Looking to the future, industry leaders are taking a broader view of the digital thread’s value potential, with more investment in production and service use cases. They view the next stage as more complex and transformative to their companies. Fortunately, several have been successful in establishing programs that enjoy strong support from a well-informed and motivated senior management. However, many others have not.

All Top 5 pain points being targeted in future implementations relate to accessibility and traceability across data elements, especially traceability of requirements throughout the product lifecycle. Systems engineering is featured prominently in many responses, including ranking as the top new value opportunity being targeted in future digital thread implementations, which aligns with CIMdata’s view that systems engineering is a principal driver of the digital thread.

Digital Thread Investment Priorities

RELATED: Requirements Traceability Diagnostic

Strategies for Success

An area of divergence between industry leaders is in the focus of their implementations. For some, the focus is providing interfaces to source applications to extract and associate product data artifacts and attributes. For others, the key is the association and traceability of dependencies between artifacts in support of a use case. And for a few, the focus is on data governance, which they believe is foundational for enabling a richer and more extensive set of product lifecycle use cases.

The number one inhibitor to formulating and executing a digital thread strategy is “lack of interoperability between different vendors’ tools and systems.” The number one proposed means for mitigation is to “increase support of standards.”

Images showing digital thread bar chart for strategies for success

Solution Technologies

Key Technical Considerations

Core to the value of digital thread is traceability across multidiscipline sources and derivative product-related artifacts along the product lifecycle and throughout the extended enterprise.

The digital thread value landscape is distributed across a heterogeneous value chain from customer to OEM to partners and multiple tiers of suppliers. This reality drives the need for data interoperability and elevates the importance of standards and openness of enabling solution architectures.

Proven technical solutions exist for enabling the digital thread, and leading solution providers are investing heavily in research guided strategies and roadmaps to further strengthen their offerings.

Data is the foundation of the digital thread. This reality elevates the importance of sound data governance and a cleansed repository, especially as use case implementations proliferate and must be interlinked into an extended thread.

Bar chart showing Product Lifecycle Data stats

Technologies in Use Today

The technologies used to link product lifecycle data segregate into three tiers as shown in Figure 16. The top tier, which has the longest history, includes PLM and PDM, followed by ERP, and custom applications. The middle tier consists of application and data integration tools. These are followed by the third tier of newer specialty technologies for combining data from multiple sources and establishing linkages and traceability. We can expect the ranking of these specialty technologies to rise significantly over the next few years.

Solution Capability and Provider Alignment

Attitudes on the topic of solution capability and provider alignment are mixed. Some industry leaders are quite critical, especially regarding data model accessibility and flexibility to comply with a corporate data governance strategy. Other interviewees are somewhat neutral or slightly positive. They feel that some providers are moving in the right direction; some are not. Several feel that solution capabilities have improved significantly overall in the last 5-10 years and that, despite some remaining gaps, are now fully capable. Some express satisfaction that “good partnering” is happening.

RELATED: Reduce Project Risk in the Product Development Process

Jama Software® Solutions

Jama Software®’s industry-leading platform, Jama Connect®, helps teams manage requirements with Live Traceability™ through the systems development process for proven cycle time reduction and quality improvement. The number-one problem product engineering organizations face is managing requirements traceability spanning siloed teams and tools (e.g., design, hardware, software, test, risk, quality) which creates an increased risk of negative outcomes such as extensive rework, delays, and cost overruns.

Jama Connect enables digital engineering for innovative organizations in aerospace, automotive, medical, and industrial verticals. The future of product development relies on agile and transformative digital engineering techniques. Jama Connect helps customers solve their toughest challenges and simplify complex mission-critical system development across complex partner and supplier ecosystems.

Jama Connect seamlessly integrates with the product development technology stack. Organizations can take advantage of Jama Connect’s integration solutions with market-leading tools for design and simulation, task management, lifecycle management, quality assurance, and testing. Teams can work in their preferred tools while ensuring all requirements are verified and validated to achieve complete traceability.

V Model image showing Jama Connect integrating with several additional platforms

Live Traceability with Jama Connect Delivers:
  • 1.8X faster time to defect detection
  • 2.1X faster time to execute test cases
  • 2.4X lower test case failure rates
  • 3.6X higher verification coverage

Jama Software’s benchmark study for monitoring and measuring traceability through its Traceability Score™ has shown that companies that have a higher traceability score in the digital thread have faster cycle times and defect detections. This allows companies to be nimble and be twice as fast in releasing products vs. companies that do not monitor and measure traceability in their product lifecycle. Requirements Traceability Benchmark

This has been an excerpt from the eBook, “CIMdata: Digital Thread in Aerospace and Defense”
Click HERE to download the full version.


In this video, we demonstrate the Baselines feature in Jama Connect®. 

Jama Connect Features in Five: Baselines

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 expert Julie Goodner, Senior Product Manager, demonstrates Baseline capabilities in Jama Connect.

 

VIDEO TRANSCRIPT:

Julie Goodner: Hi. My name is Julie Goodner. I’m a Senior Product Manager here at Jama Software. In this video, I will walk you through Baselines in Jama Connect. I’ll cover what a Baseline source is, what Baselines are, when to create one, and some of our new Baseline features.

A Baseline source in Jama Connect is a collection of all versions of the requirements or other items that have been selected for a Baseline. A Baseline in Jama Connect is a snapshot in time and you can create a baseline to capture any milestone. In addition, a Baseline is also automatically captured when a review—or a revision to a review—is created.

A Baseline allows our users to capture the state of their content in alignment with key points in their product development cycle, such as during peer reviews, at key approval gates, or when generating documents from Jama Connect. In addition, utilizing Baselines allows our users to compare items as they change over time.

RELATED: Requirements Traceability Diagnostic

Goodner: With Baseline sources, you can see if the Baseline or Review contains signatures, see Baseline statuses, quickly navigate to a Review, or do a comparison summary between two Baselines and export the redlined report.

With Baselines, you can add electronic signatures, compare two Baselines with redline edits from within Jama Connect, compare items in your Baseline items to their current state in the project, add a status, and navigate to the Baseline version in the project view.

So now let’s get into the demo.

RELATED: The Benefits of Jama Connect®: Supercharge Your Systems Engineering and Development Process

Goodner: The Baseline can be manually created in many ways:

  • Right-clicking on a container, set, folder, or item, and adding a Baseline.
  • From the Filters tab, select any filter, and add a Baseline.
  • From the Baseline tab, you can select “Add a New Baseline” from the dropdown, or you can right-click on an existing source and add a Baseline.
  • From our new Baseline source header, you can add a Baseline from there.

Again, a Baseline is automatically created with any Review or revision of a Review.

RELATED: Reduce Project Risk in the Product Development Process

Goodner: From the Baseline source, you can see high-level information about its corresponding baselines that used to be hidden within a baseline details section. When selecting two Baselines, you can choose to do a comparison. This comparison summary model informs you have any updates that have been changed. You can also export that report and view the red line edit.

From a Baseline in the List View, you can see what relationships, categories, or other metadata were used to associate with the items at the time of the Baseline. When selecting the link in a Baseline, it will take you to the historical view from within the project.

From the Baseline Document View, you can choose to compare and see the differences in redline edit within Jama Connect, no longer needing to download reports.

If you would like to learn more about Jama Connect, how Jama Connect can optimize your product development process. Please visit our website at jamasoftware.com. If you’re already a Jama Connect customer and would like more information about Baselines, please contact your customer success manager or a Jama Software consultant.

Thank you.

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


Medical Device & Life Sciences

In part two of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect®. Click HERE for part 1 and  HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”

Jama Connect Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2

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 part two of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, continues his demonstration of the latest solution offerings for Medical Device & Life Sciences in Jama Connect.

Click HERE for part 1 and HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”

VIDEO TRANSCRIPT:

Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going 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.

So the first thing I want to show is our Jama Connect Advisor™ example data. Released in 8.80, this new feature enables EARS and INCOSE rules for requirement quality authoring. Additional licenses are required, but wanted to share some of the capabilities examples right out of the box. So as you can see here, what we’ve shown, is, you know, the general use case description, but also an example requirement with the Jama Connect Advisor output. Again, this is a nonfunctional screenshot. We just wanted to share some of the information that you may see when having Jama Connect Advisor. Here’s, for example, for a green status, which means generally a good requirement, but let’s take a look at what a yellow requirement or maybe something that may need some rework and you can see which of the rules, particularly INCOSE, that is now flagged that is, you know, has some potential issues. And then the same is true with our red level of requirements.

So again this is potentially a useful tool to kind of share while authoring requirements for your project.

RELATED: The Top 5 Challenges in Digital Health Solution Development

Balgos: The next use case that we’d like to talk about is the industry standards trace. So in the standards use case, the first thing I want to share is this relationship rule diagram. As you can see here, we have user needs trace to system requirements, which is, you know, aligns with [21 CFR] 820.30, but also we have this new item type called standards reviewed is now traced to system requirements.

If you upload your standards into Jama Connect, what we can see for this particular item type is that we’ve identified now the standard, the clause number, the clause text, and identified does the standard apply for this particular project. What’s nice about once this is in Jama Connect, I can now actually do a trace downstream to the system requirement. Note, this project does not provide any standards due copyright issues, customers won’t need to vision their own standards for use and apply appropriately. The last thing we want to talk about is really the reports on this medical device framework update.

RELATED: Jama Connect® for Digital Health Solution Overview

Balgos: What I wanted to share is if I go into the admin area and I take a look at the reports, you can see now that we’ve now had the ability to upload and, you know, manage our own reports, but we’ve provided some additional categories and information to help organize the many reports that we have. As you can see here, we’ve identified some trace reports and some new SaMD reports. So if I go back to the project and let’s take a look at, let’s say, system requirements, I want to show you a new trace report that shows requirements to verification-only events. So for example, let’s say if we go on to, let’s say, our subsystem requirements that we have here I’m gonna pick this one.

I’m going ahead and go at export. Again, this is available now into the Medical Device Framework 2.0. What I want to show you is requirements to verification trace report. So if I go ahead and hit run, create a report, I’m gonna download it, and then what wanna share is this new trace report that we have, which now shows you the requirement, the verification test case associated with the requirement, But in addition, the latest test run and its test result status.

RELATED: Requirements Traceability Diagnostic

Balgos: So this helps clearly identify the requirement to verification traceability that’s may needed and they may be able to submit to your DHS. We have a similar one called the user needs to validation transport that falls the same above. The other thing we wanted to show is that we’ve added a couple popular and useful GitHub reports to this solution update. These are located up in our run reports area where we actually now included the test results report group by test case and the test result report grouped by test cycles, which are really, really helpful for understanding test management scenarios.

Okay. That’s for the general update for the the standard medical device framework. We have an additional updated solutions such as software as a medical device, research use only, and our new self-guided onboarding framework. So we definitely encourage you to look at that further.

Please contact your Jama success manager or consultant to learn how to implement these new solutions at your organization.

Thank you.

 

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


Large Language Model (LLM) Image

How to Plan for Large Language Model (LLM) Adoption Within Your Engineering Organization

The initial free and unprotected access to ChatGPT (the most well-known Large Language Model) has led some individual engineers to try out the tool by using company owned trade secrets and intellectual property (IP) as prompts. The predictable result has been IP leakage with numerous high-profile examples, including at Samsung. As a result, many companies, including Apple, have banned internal use of the technology outright. Additional risks are just starting to be understood given the lack of consent provided by the actual owners of content that was used to train the LLMs. This leaves the concept of ownership of LLM output, and the ability to protect intellectual property that includes LLM output in question and legal experts are advising caution. Clearly, it will take some time for legal frameworks and precedents to be established for the use of LLMs in product development and for enterprise-class integrations to be developed to LLMs that at properly allow for company level standards and governance of IP. Numerous lawsuits, such as Clarkson v OpenAI, are now underway alleging all of the data to train the LLMs was obtained without consent or renumeration and violates copyright law.

RELATED: Best Practices Guide to Requirements & Requirements Management

Clearly, it will take some time for legal frameworks and precedents to be established for the use of LLMs in product development and for enterprise-class integrations to be developed to LLMs that properly allow for company level standards and governance of IP. Given the risks and unresolved legal questions LLMs pose for product development, how should an engineering organization plan an adoption path to achieve potential benefits from intelligent assistance for engineering tasks?

The guidance we provide our clients is to focus on the following three areas, ranked in order of greatest benefit from intelligent assistance:

  1. Improve requirements quality – Poorly specified requirements account for up to 64% of defects and are the costliest ones to correct. The International Council on Systems Engineering (INCOSE) and the Easy Approach to Requirements Syntax (EARS) have established best practices for requirements specification and unfortunately, LLMs are trained on publicly available requirements content that is rife with all the most common errors addressed by INCOSE and EARS. The best intelligent assistant to improve requirement quality is a Natural Language Processing (NLP) approach that analyzes requirements against INCOSE and EARS best practices and recommends improvements – which is exactly what Jama Connect Advisor™ does. Jama Connect Advisor protects all IP and engineers learn how to write better requirements through intelligent guidance.
  2. Manage by exception – The engineering function is one of the last in the enterprise to be managed through data. The engineering process is often fragmented across teams and tools which leads to late identification of cross-discipline issues that result in defects, delays, cost overruns, and recalls. Jama Connect® intelligently solves this problem through Live Traceability™ which automatically syncs data across best-of-breed tools and tracks engineering progress against the chosen development model (e.g., V-model) to identify issues as early as possible and thereby reduce the risk of defects, delays, cost overruns, and recalls.
  3. Increase engineer productivity – The biggest drains on engineering productivity are most commonly integration meetings and rework. Jama Connect’s Live Traceability intelligently alerts teams to impactful change from other engineering disciplines. Live Traceability eliminates the need for time-consuming and mind-numbing integration meetings and is proven to reduce rework based on our groundbreaking benchmarking study. Further productivity gains can be achieved by leveraging LLMs for requirement decomposition and we intend to be one of the first to market with an enterprise-class solution that protects IP and enables company standards.

RELATED: Best Practices Guide for Writing Requirements

To get started with intelligent assistance, learn how best to improve requirements quality across your engineering organization with the NLP application of EARS and INCOSE best practices.


In part one of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect. Click HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1

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 part one of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect.

We will share part two of this video series here once it’s published.

VIDEO TRANSCRIPT:

Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device & Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.

So the first thing I want to show is the general organization and layout of our new Medical Device & Life Sciences Solution 2.0. The first thing I want to show is that this new folder that actually has our new Medical Device framework and our other additional popular frameworks such as SaMD and Consumables frameworks. 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 three hundred-plus customers and their practices using Jama Connect.

So now let’s go ahead and jump into the tool. 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.

RELATED: Jama Connect® Customer Success Programs

Balgos: The most common example is associated with risk. Not all risk controls are requirements, so we still need a way to trace to these non-requirement risk controls. These controls may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.

Another thing that we’ve done is actually updated our hazards library to include general hazards identified in ISO 14971. So you have pretty much a starting place with your hazard library The next item that I like to talk about is the risk Lookup Matrix. Available in [Jama Connect] 8.74, this feature allows a new Lookup Matrix risk analysis approach that automatically outputs the desired content based on the preconfigured Lookup table. This really aligns with [ISO] 14971.

Let me show you a quick demo of this. We’ve now implemented this as part of our Medical Device & Life Sciences Solution 2.0. 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 [ISO] 14971 schema of hazard sequence events, hazard situations, harms, but here is now where we’ve implemented this new Lookup Matrix feature. Where now I’ve identified the input pick list where I may be able to change this, and then that automatically updates my risk level based off that matrix.

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

Balgos: So for example here, if I went ahead and increased this to frequency and I increase my severity from 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 in Five video that shows cases 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 preconfigured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, when I look at my item type, I’ve now included preconfigured D FMEAs, Process FMEAs and, Use FMEAs that you may configure based on your organization.

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

Balgos: The intent of this is really to continually improve and provide new solutions to our customers based on customer feedback, industry trends, and best practices.

The industry vertical solution updates expand new use cases and solutions to address complex challenges while continuing to comply with industry regulations. Please contact your Jama Connect success manager or consultant to learn how to implement these new solutions at your organization.

Thank you.

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


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.


AECO

In this blog series, we’ll recap the “Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®” whitepaper. To read part 1 of this two-part series, click HERE.

Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 2

Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®

Six Key AECO Challenges Continued…

CHALLENGE #4 – Inability to Track and Manage Owner Changes

The AECO industry is a complex and dynamic industry that involves many stakeholders and moving parts. One critical aspect of managing AECO projects is conducting change impact analysis, which involves evaluating the potential effects of proposed changes to a project’s design, scope, schedule, and cost. The inability to effectively track and manage change can lead to significant negative impacts on project outcomes.

For example, without a proper analysis, changes may be implemented without understanding their full downstream consequences, resulting in unexpected delays, cost overruns, safety hazards, and quality issues. Furthermore, failing to conduct a change impact analysis can undermine project team collaboration, trust, and communication, leading to increased conflicts and disputes. Therefore, incorporating change impact analysis into AECO projects is crucial for ensuring project success and minimizing risks.

A real-world example might be: One contractor decides to make a window larger. This change might impact the structure of the building, air conditioning needs, electrical placement, the roof, and even violate building codes. While a simple change like this may seem insignificant, it will often have ripple effects throughout the development process. Without proper visibility, collaboration, and consideration, this can result in rework, delays, and increased costs across the board.

Jama Connect is a powerful tool that can help the AECO industry effectively manage change by providing a centralized platform for capturing, tracking, and analyzing changes across the end-to-end project development lifecycle. Jama Connect’s change management capabilities enable project teams to quickly assess the impact of proposed changes and make informed decisions about their implementation. With Jama Connect, project teams can easily collaborate and communicate about change requests, ensuring that all stakeholders are aware of the potential impacts and can provide input. Additionally, Jama Connect provides real-time visibility into the status of changes, allowing project teams to proactively identify and address any issues that arise. This level of transparency and control helps to reduce the risk of errors and delays, ensuring that projects are delivered on time and within budget. Overall, Jama Connect is an essential tool for the AECO industry to effectively manage change and ensure project success.

RELATED: Best Practices Guide for Writing Requirements

CHALLENGE #5 – Inefficient Design Review Process

In the AECO industry, design review processes are critical to ensure the quality and compliance of construction plans. However, inefficient design review processes can lead to significant delays, cost overruns, and mistakes in the final product. One common issue is the lack of clear communication and coordination between different stakeholders, such as architects, engineers, contractors, and clients. This can result in conflicting feedback, revisions, and approvals that prolong the design review process. Additionally, outdated or manual review methods, such as paper-based markups and physical meetings, can further slow down the process and increase the likelihood of errors. Overall, improving the efficiency of design review processes in the AECO industry requires better collaboration tools, streamlined workflows, and clear communication channels.

Jama Connect can play a significant role in streamlining the design review (and design verification) process in the AECO industry by enabling collaboration, improving communication, and reducing errors. It is required that engineering firms provide specific validation of how their proposed design meets the original owner’s requirements, and with Jama Connect, that process is simple.

Here are some specific ways Jama Connect can help with the design review process:

  • Centralized platform for design review: Jama Connect provides a centralized platform for design review, allowing all stakeholders to access the latest designs, review comments, and feedback in real-time. This eliminates the need for stakeholders to send design documents back and forth via email, which can be time-consuming and result in errors.
  • Collaborative review process: Jama Connect enables collaboration between all stakeholders during the design review process and documents the history of every change, who made it, and why. Stakeholders can provide feedback and comments on designs, and other stakeholders can respond to those comments, creating a collaborative feedback loop. The ability to trace designs back to the original requirements is a key component of moving smoothly through the design process, and with Live Traceability™ within Jama Connect, this traceability is automatically created as you go through the design and review process and gives an owner a complete record for their project. This helps to ensure that all stakeholders are on the same page, reducing errors and misunderstandings.
  • Version control and tracking: Jama Connect provides version control and tracking features that allow stakeholders to see the history of design changes, track who made each change, and ensure that everyone is working with the latest version of the design. This helps to avoid errors that can occur when stakeholders work with outdated or incorrect design documents.
  • Approval workflows: Jama Connect allows organizations to define and enforce approval workflows for design reviews. This ensures that designs are reviewed and approved by the appropriate stakeholders before being finalized, reducing the risk of errors and ensuring compliance with industry standards and regulations.
  • Reporting and analytics: Jama Connect provides reporting and analytics features that allow organizations to track the progress of design reviews, identify bottlenecks, and analyze review data. This helps organizations to continuously improve their design review process, reducing errors and improving efficiency over time.

AECO Projects Must Move Quickly While Balancing Budget and Quality:
Learn More: Buyer’s Guide- Selecting a Requirements Management and Traceability Solution eBook

CHALLENGE #6 – Lack of Accountability

Accountability is essential in the AECO industry, as it ensures that all stakeholders are responsible for their actions and decisions. This includes ensuring that project requirements are met, timelines are followed, and budgets are managed effectively.

Jama Connect can help solve this challenge by providing a platform for managing project requirements. This includes defining responsibilities and tracking progress against milestones. This helps ensure that all stakeholders are accountable for their actions and decisions.

Conclusion

In conclusion, while the AECO industry is facing many unique challenges, there is also an opportunity for process improvement that will allow stakeholders to reduce delays, project risk, and overspending. Jama Connect can help facilitate collaboration, prevent scope creep, reuse requirements, designs, knowledge, and components, and improve the design review process. By leveraging Jama Connect, AECO organizations can overcome many of the challenges they face and meet the evolving needs of clients and society while navigating a rapidly changing business landscape.

Click HERE for part 1 of this series and HERE to download the entire whitepaper,
“Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®“

Want to Get Your Budget Back and Simplify Your AECO Projects?
Get Started By Trying Out Our Award-Winning Requirements Management Software Platform!


Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 1

Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®

Introduction

The AECO (Architecture, Engineering, Construction, and Operations) industry faces various challenges and opportunities as it adapts to changing market trends and technological advancements.

AECO is the largest industry in the world, according to McKinsey, and makes up 13% of global GDP. The industry has seen a steady increase in demand for sustainable and energy-efficient designs, as well as for innovative building materials and construction techniques. Additionally, digital technologies such as Building Information Modeling (BIM), cloud-based collaboration, and requirements management tools have become more prevalent, enabling better communication and project management across different stakeholders.

However, the industry is also grappling with issues such as a shortage of skilled labor, rising material costs, and increasing regulatory requirements. As such, the AECO industry is undergoing a transformation as it seeks to meet the evolving needs of clients and society while navigating a rapidly changing business landscape.

One of the challenges in adapting to changes in AECO is that a typical project involves many stakeholders, including architects, engineers, contractors, owners, and regulators, often with different business models and goals. These stakeholders must work together to design, build, and maintain the built environment, but structural and contractual agreements often make it difficult to communicate with each other to deliver projects on time and budget.

In this whitepaper, we will explore some of these challenges and how a requirements management solution like Jama Connect® can help solve them.

RELATED: How to Integrate Jama Connect® with Microsoft Excel Using the Jama Connect Interchange™ (JCI)-Excel Functions Module

Six Key Challenges

CHALLENGE #1 – Lack of Collaboration and Poor Communication

Collaboration and communication are essential in the AECO industry but can be difficult to achieve. With dozens, if not hundreds of individual firms involved in any given project, each stakeholder brings their own expertise, agenda, and perspective, which can lead to misunderstandings and communication breakdowns. This can result in rework, delays, and increased costs throughout the development process.

A requirements management solution like Jama Connect can help facilitate collaboration by providing a central repository for all project requirements. For example, the owner could post their original requirements into a Jama Connect environment allowing all stakeholders, project managers, and contracted firms access to the same information to jointly verify that their work is aligned to achieve project goals. Using Jama Connect to manage this process goes beyond just document sharing, by creating a record of verification that the requirements are met, or if there are changes, that those modifications are also tracked and validated back to the source.

CHALLENGE #2 – Scope Creep

Scope creep is a common issue in the AECO industry, where projects can become more complex and costly than initially planned. Scope creep occurs when project requirements expand beyond the original scope, leading to additional work, time, and costs that were not anticipated in the project plan. Broadly, this is referred to as the ‘change order’ process and results in project delays in addition to cost increases. Sometimes the changes result from a lack of clear communication and project management, where changes or additions to the project scope are not properly documented or approved. Additionally, external factors such as changes in regulations, client requirements, or unexpected site conditions can also contribute to scope creep. Managing scope creep in the AECO industry requires a proactive approach, including regular communication and documentation of changes, proper project planning and risk management, and stakeholder engagement to ensure that project expectations are aligned with project scope.

Jama Connect can help prevent scope creep by providing a platform for managing project requirements. This includes defining the scope of the project and ensuring that all stakeholders are aligned on project objectives and their plans are validated against the owner’s project requirements documents. Any changes to the project scope can be easily tracked and managed — in real time — within Jama Connect.

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

CHALLENGE #3: – Redoing Similar Work Across Multiple Projects

Requirements reuse is a practice in the AECO industry that involves leveraging existing design requirements to develop new projects. By reusing requirements, designers and engineers can save time and resources while improving project quality and consistency. This can be particularly useful for large-scale projects or projects with similar design requirements, where requirements can be adapted and refined to fit new project contexts. Reuse of requirements can also help to ensure compliance with regulations and standards, as existing requirements can be used as a baseline for new projects.

While reuse can save an incredible about of time and money for all stakeholders involved, there needs to be an upfront investment in both tools and processes. To facilitate reuse of requirements, effective requirements management processes and tools are needed to capture, store, and manage requirements. Additionally, collaboration across different stakeholders is important to ensure that requirements are applicable and relevant to new projects.

Jama Connect is a powerful platform that can help the AECO industry with reuse in a number of ways.

Here are some examples:

  • Requirements reuse: In the AECO industry, many projects have similar requirements. By using Jama Connect, organizations can create reusable templates and structures to reuse requirements across projects, saving time and effort. This can be especially useful for organizations that work on multiple projects simultaneously or for those that have a large number of projects with similar requirements.
  • Design reuse: Just like with requirements, many projects in the AECO industry require similar designs. Imagine a wind farm project for example, where each of the turbine structures are identical in design. By reusing designs, organizations can reduce design time, improve consistency, and minimize errors. Jama Connect allows organizations to easily store and retrieve design artifacts, making it easy to reuse them across projects.
  • Knowledge reuse: Over time, organizations in the AECO industry accumulate a lot of knowledge about their projects, including best practices and lessons learned from experience. Jama Connect provides a central repository for this knowledge, making it easy to share and reuse across projects.
  • Process reuse: Many organizations in the AECO industry have well-established processes for managing projects, for example processes like issue resolution and design-change tracking. By using Jama Connect, organizations can capture these processes and reuse them across projects, improving consistency and efficiency.
Stay tuned for part 2 of this two-part series. Click HERE to download the entire whitepaper,
“Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®“