Jama Software® Announces Largest Scale Achieved by Any Requirements Management Software
Jama Connect® 9.5 proven to scale to at least 10 million requirements in a single project to handle the largest product, systems, and software development efforts.
Jama Software®, the industry-leading requirements management and traceability solution provider, has announced that Jama Connect® has set yet another scalability record with over 10 million requirements managed in a single project (within a standard cloud instance) with P75 user interface load times under three (3) seconds. 10 million requirements per project represents a new benchmark in the industry, clearly showing that Jama Connect is able to meet both the current and future scalability needs of our customers. It is also important to note that no project data storage limits were hit during this boundary condition test, so the actual limit has not yet been reached.
Engineering organizations are looking for software partners that can handle large-scale, collaborative projects that span engineering disciplines, customers, and suppliers. This performance benchmark demonstrates Jama Connect’s unique ability to handle the scale required within a single project. Today, our customers work with tens of millions of requirements across projects in a single instance of Jama Connect. This latest single project scalability milestone adds to Jama Connect’s market-leading standing for security, scalability, and performance in the cloud including:
Over 100,000 trailing 90-day active users
Daily users spanning 82 countries
16ms First Input Delay (FID) response times
P75 response times of 2.7 seconds
The only requirements management application that is SOC 2 Type 2 certified at the environment AND application layers
The richest REST API with over 200 separate API functions
Over 600 million API cloud service requests per month
“Jama Software continues to lead the market in performance, security, and usability at scale,” said Josh Turpen, Chief Product Officer at Jama Software. “We are pushing beyond the 10 million threshold and will continue to deliver unmatched cloud capabilities to our customers.”
About Jama Software
Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
For more information about Jama Connect services, please visit www.jamasoftware.com
https://www.jamasoftware.com/media/2023/10/2023-10-05-v3-largest-scale-by-rm-software-release.jpg5121024Karrie Sundbom/media/jama-logo-primary.svgKarrie Sundbom2023-10-05 06:30:222023-10-05 11:49:06Jama Software® Announces Largest Scale Achieved by Any Requirements Management Software
In this blog, we recap our webinar, “Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development”. Click HERE to watch the entire webinar.
Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software®
During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards.
Key takeaways from this webinar:
Learn about available diagnostic offerings in Jama Connect, such as: ASPICE, ISOS26262, and ISO21434
Learn about the benefits of diagnostic offerings, how they will expose risks to compliance, and which one is best for your organization
See firsthand how Jama Connect helps teams reduce unacceptable risks
Discover how Jama Connect can empower Automotive and Semiconductor development teams to evaluate and ensure compliance.
Below is an abbreviated transcript of our webinar.
Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development
Steve Rush: Hi everyone. I’m happy to be here today to take you through the presentation. I wanted to start with a high level agenda and an introduction. We’ll be discussing Automotive compliance in general. To start, we’ll be looking at specific service offerings that you can use to help leverage, to evaluate your compliance against certain Automotive standards.
There are two forces often related that I like to think about when it comes to compliance that really impact the organization as a whole, from engineers to executives and everybody really in between. And those are process and quality. And I like to think about compliance as the intersection of those two often related ideas. Meeting the objectives of these standards may achieve both process and quality, but developing a compliant process and system, this will speed up development by instituting good process and reducing rework. It will help catch and identify defects early in the development process. However, there’s many evolving regulations and standards in this Automotive sector that make the idea of compliance all the more challenging to understand, let alone demonstrate. Perhaps you don’t even know where to start when it comes to achieving compliance in an Automotive system. It might feel like you are building a car while it’s driving.
At the same time tasked with implementing the process and tools to support the process and unsure which should come first. And we want to talk a little bit about this through the lens of compliance and make the case that Jama Connect is a tool well suited to get you up and running quickly, optimized against popular Automotive standards. To assist with this, we’ll discuss the diagnostic that Jama Software offers as a service that’ll help you navigate these important compliance questions. But I fully believe that by meeting the objectives of some of these critical Automotive standards we will discuss today that you’ll balance both process and quality and achieve compliance.
Sam Yerramalla: Today we are highlighting some offerings that will help guide Automotive customers or prospects like you with your compliance process. We feel these diagnostics can be very helpful whether you are a customer of Jama Software or a prospect. If you’re a Jama Software prospect who’s not yet purchased Jama Connect, these diagnostics makes the case that Jama Connect can help you meet the objectives of the Automotive standards. And namely, there are three standards offerings that we provide. One is the ASPICE Diagnostics, the Automotive Functional Safety Diagnostics, and the Cybersecurity Diagnostics. Now these diagnostics can help you navigate the classic process versus tool conundrum. That is if you’re trying to understand whether you should build the process first or buy the tool first, you’ll first see firsthand how Jama Connect will help shape the process. If you’re a Jama Software customer, you can use these diagnostics as a baseline. Oftentimes, we get busy with our day-to-day work and we may drift away from the larger big picture.
And these diagnostics are meant to guide you to bring light into areas that you need improvement or any optimization of your current Jama Connect process. You can also be paired with a Jama Software consultant or a solutions architect who will take you through the diagnostics start to finish. The time commitment for each of these diagnostics is about two to three hours. We feel that’s reasonable considering the benefits you may get out of this. We focus on the outcomes and the objectives and how this will truly help meet your compliance needs by optimizing your Jama Connect usage. If you’re a customer or getting up and running in Jama Connect, if you’re a prospect who’s looking for purchasing Jama, you can see these diagnostics offerings along with other offerings that we provide on the Jama Software Success Program page at Jamasoftware.com/success. Here you’ll see details on the compliance offerings that we just mentioned and a lot more other offerings including offerings on onboarding Jama Connect, improving your process and requirements, quality, traceability, et cetera.
Yerramalla: You can also request an offering if you have a service program with no assigned consultant and our operations team will pair you up with someone. So as far as the Automotive standards and alignments are concerned, the diagnostics offerings that we provide are aligned to the three standards, the Automotive Spice, ISO 26262 and ISO 21434. Only certain areas of those standards are in scope. For example, things like part seven of the ISO 26262 for production and operation and decommissioning are not covered here. But you will see some of these sections here are covered by the diagnostics. So depending on which diagnostics is right for you, the risks that are identified will align to the different areas that you see on the screen. Now, it may be that you want to align to more than one standard. We certainly put you through multiple diagnostics to identify your risks pertaining to each of these standard.
The model which we use is the same, but the recommendation we provide and tailored solution that the diagnostics provides will be custom based on each scenario. And if you don’t know where to get started or you don’t know which of these diagnostics that you need to start first. Some things are obvious, again, that if you’re looking for cybersecurity compliance and that is of the greatest concern for you, then Cybersecurity Diagnostics, the 21434 is right.
And if you’re looking for developing any functional safety products that are used in the Automotive, then the ISO 26262 diagnostics is the correct one to start with. And if you’re looking for any software process improvements or quality management, then ASPICE is the place to start. But sometimes you need both APSICE and functional safety, for example, in which case we suggest the ASPICE Diagnostics first. And the reason is that we rank in the process ASPICE about the functional safety is that if you have a high level of ASPICE maturity or on the other side, if there are several risks that are flagged from the ASPICE Diagnostics, then those will impact your Functional Safety Diagnostics already.
So you would’ve covered those parts of it that as a prerequisite for the functional safety. And then the spirit of ASPICE is really the quality management. And this is important in every engineering organization. So if you’re unsure where to start, then ASPIE Diagnostics is one place. And if you don’t need to prove compliance to the latter, it’s really good because honoring it, the lead benefits in your process.
https://www.jamasoftware.com/media/2023/09/wb-2023-09-27_Compliance-Made-Easy.png5121024Steve Rush/media/jama-logo-primary.svgSteve Rush2023-10-04 03:00:262024-01-17 23:12:38[Webinar Recap] Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development
EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights
Are you grappling with the intricacies of the EU Medical Device Regulation (EU MDR) and searching for clear answers to your most pressing questions? Look no further!
In this blog post, we’ve teamed up with subject matter expert Saby Ágai, Senior Professional Services Consultant at Jama Software®, who will shed light on the complex world of medical device compliance.
Overview + General Information
Why was the MDD (Medical Devices Directive) updated?
Saby Ágai: MDD entered into force in 1993, 30 years ago. There have been many changes over these three decades. There have been technological changes since then, software for example has more attention now than it had 30 years ago.
Patient demographics characteristics have changed, now it is a more aging population than it was 30 years ago. Medical device safety should correspond to these changes.
MDD was primarily focused on medical device commercialization criteria rather than looking at patient safety from a holistic perspective.
What are the most important changes introduced by the EU Medical Device Regulation?
EU MDD was focused on commercialization guardrails and market clearance criteria first.
EU MDR accounts for the full technological landscape, establishing guardrails for the regulation, manufacturing, and commercialization of medical devices.
Given that timelines may continually change, what is the latest information regarding extensions?
Implementation/Adaptation + Need for Process Improvement
The EU MDR has changed how medical devices are covered. What opportunities and challenges might this expansion present for manufacturers?
Opportunities:
Manufacturers can deliver to the market higher levels of safety for their medical devices.
Manufacturers can be more aware and in control of their medical device lifecycle.
Potentially this could result in less recalls and less rework, and fewer customer complaints. There is also an opportunity for an easier pathway to other markets like US, Canada, Japan, and others.
Challenges:
Steep learning curve to adopt to the new regulation
Lack of professional, lack of experiences how to adopt to the new regulations
Optimizing efforts and resources spent on the adoption of MDR
What strategic steps should medical device companies and regulatory experts take to ensure a successful transition in light of the changes brought on by the MDR and its effect on CE markings?
Manufacturers should have a plan for MDR transition
Expert panel of the EU could be involved to receive professional support
Regulatory professionals should be competent to the new regulations
Best practices across the medical industry should be utilized for the transition
How can medical device manufacturers improve their Quality Management Systems (QMS) to be better at compliance? What new approaches can be used to make business growth and product innovation possible?
New quality management processes should be developed to correspond to the requirements of the MDR. Manufacturers should also revisit their core processes including quality assurance, risk management, and post-market process to see if re-implementation needed to ensure compliance with new MDR.
Related: Learn about the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry:
Data & Documentation
What impact does the EU MDR’s demand for increased device traceability and technical documentation have on promoting patient safety and regulatory visibility? What potential advantages and obstacles might exist when attempting to reach these outcomes?
Patients will benefit from the increased focus on safety and regulatory visibility on medical devices that MDR demands. On the other hand, novel technologies in medical devices may suffer from delays to be available early for patients. It is a balance though between efficiency and safety that always was there. The increased volume of technical documentation can lead to higher levels of design awareness for the manufacturers, on the other hand the increased resources needed to get there need to be financed.
How can medical device manufacturers collaborate with notified bodies and competent authorities to ensure a streamlined and efficient certification process?
There is a conflict of interest that does not allow the Notified Body and Authorities to provide consulting on MDR compliance for the same manufacturer that registered for certification. Manufacturers can help the certification process by signing up for certification on time. Manufacturers also can streamline certification processes by involving competent and experienced professionals to fulfill the Person Responsible for Regulatory Compliance (aka PRRC) role.
More attention on post-market surveillance processes.
Technical documentation:
Let’s investigate the products listed in Annex XVI of the MDR and discuss the effects this will have on both manufacturers and healthcare providers. How can stakeholders take advantage of this inclusion to create positive results?
Those products are subject to the MDR, even though those are without an intended medical purpose. These products previously were unregulated products and the MDR introduces new manufacturing and surveillance requirements. A positive result is the higher level of transparency of the design, manufacturing and post market activities of these products. Users of such products benefit from a higher level of safety when using these products.
Will the stricter regulatory requirements of the EU MDR hinder or promote innovation in the medical device industry?
There is always a balancing between introducing novel technologies to patient treatments that potentially can save or extend our life as a patient versus using only high level of safety assured medical devices. If the current MDR hinders or promotes innovation only time will tell.
How can manufacturers balance the need for compliance with the desire to bring innovative products to market in a timely manner?
Market regulations are prescriptive to the given market. Manufacturers probably will deliver slightly different functionalities for essentially the same medical devices depending on how the market regulation allows for more open for novel technologies.
Patient Safety
How does the EU MDR change clinical evaluation requirements? And how can the industry adapt to these changes while continuing to prioritize patient well-being and efficacy?
The MDR has more rigorous clinical evaluation requirements, necessitating robust clinical data to support the safety and performance claims of the device. For each device, the manufacturer must plan, establish, document, implement, maintain and update a post-market surveillance (PMS) system that is proportionate to the risk class and appropriate for the type of device. The PMS system actively and systematically gathers, records and analyses data on the quality, performance and safety of a device throughout its entire lifetime. Post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation. It is conducted in accordance with a PMCF plan that is an element of the overall PMS plan.
What opportunities does the EU MDR present for enhancing patient safety through better data collection and analysis?
Clinical evaluation and post-market related information will be more transparent for the medical devices; therefore, manufacturers will have more opportunities to analyze device safety based on adverse events of similar types of devices.
How does the increased emphasis on clinical data and post-market surveillance impact medical device manufacturers’ approach to product development and monitoring?
Clinical and post-market data collection should drive the design effort by transferring efficacy and safety related subjects back to development. Also, the analyses of similar products post market reporting enable manufacturers to enhance the safety of their medical device designs.
How can manufacturers leverage the new post-market surveillance requirements to proactively identify and address potential issues with their products?
MDR mandates and sets requirements for the post-market surveillance process. PMS process should be part of the manufacturer’s Quality Management System.
Manufacturers can use proactively the data gathered as part of the post-market activities for the following:
to update the benefit-risk determination and to improve the risk management;
to identify the need for preventive, corrective or field safety corrective action;
to identify options to improve the usability, performance and safety of the device;
to detect and report trends.
Conclusion
How will the EU MDR impact medical device companies operating outside the EU but wishing to access the European market?
For new arrivals, the new MDR is a demanding legislation to comply with in the European Union. Currently the conformity assessment bodies have limited bandwidth for new devices. Therefore, new manufacturers should assess the timing nature of their market access. For medical device companies operating outside the EU, there are further requirements set in the MDR in Article 11 on Authorized representatives.
How can Jama Software help organizations more easily comply with regulations like EU MDR?
Jama Software provides a solution for medical device manufacturers to adapt easily and to response quickly to the changes that the EU MDR demands. It’s achieved by providing best practices in medical device design in the context of the MDR.
https://www.jamasoftware.com/media/2023/09/2023-09-19-eu-mdr-saby-interview-1.jpg5121024Saby Ágai/media/jama-logo-primary.svgSaby Ágai2023-09-19 03:00:212024-01-17 23:16:15EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights
In this video, we demonstrate Review Center capabilities in Jama Connect®
Jama Connect® Features in Five: Review Center
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 about five minutes.
In this Features in Five video, Jama Software® subject matter expert Mario Maldari,Director of Solution Architecture, will demonstrate Review Center capabilities in Jama Connect.
VIDEO TRANSCRIPT:
Mario Maldari: Hi. My name is Mario Maldari, and I’m the Director of Solution Architecture here at Jama Software. In this video, we will demonstrate a powerful and easy-to-use feature in Jama Connect, the Review Center.
Reviews play a key role in successful product development. In this video, you will learn how to initiate a review, how to invite participants to a review, how users can complete tasks, provide feedback, and finish a review. You also see how moderators can view review activity, interact with feedback, publish revisions, compare review versions, and more. Now let’s get to the demo.
Anything in Jama Connect can be sent to the review center, individual requirements, or a set of requirements, simply right-click and send for review. This will put you into our, Review Center dialogue where you’ll have a few options to choose from, give the requirement to review a name, a deadline, and a time. You can include related items. Perhaps you want the test cases that are associated with the requirements to be reviewed as well and select those. You have a few additional options.
You can choose to have an electronic signature. You can enable time tracking, and notify when a participant finishes a review. I like that one. In this dialogue, you can add your users and assign them various roles, review approver.
And we’ll have a couple of reviewers here.
Maldari: A very nice feature of our review and approval is the ability to invite users by email. This allows you to invite, participants in your review, that aren’t part of your project, your job or project, or aren’t even part of your company. Perhaps you have, vendors that have given you requirements that you want their feedback on, stakeholders. So you can add them.
They can participate in the review, and you don’t have to add them to the project. So let’s continue on here. This final dialogue is in the details of the email that’ll be sent out to the participants. Customize this as you see fit. And let’s initiate that. Alrighty.
Essentially, the email that your participants will see will look very, very similar to this. It’ll have some instructions. It’ll have the link to the review. Their role and what the deadline is. As soon as they click on this link from their email, it’ll send them into the review. Where they’ll be able to go through and accept or reject, each item as they go through the review. You’ll be able to see the related items here in this case, the test cases because we included that in the review. So very nice to be able to include that as well. So I’ll go through and I will accept.
And perhaps there’s a case where I disagree with something or I’d like to see a change. I can get very granular in terms of my commenting ability. I can select over text. And I can say and I could even @ mention users here as well as an FYI, and I could further qualify the comment. Perhaps, say, I have an issue with it, I can enter my comment. When I’m done with the review, I simply click complete review.
And it gives me a nice summary of what has changed in my review. And at this point, I could either be done, you know, assuming maybe I accepted all the requirements. I was happy with it. In this case, since I rejected one, I’d like to request a new revision after the update is made. So the moderator at this point would get a notification that someone has completed the review. They’d be able to come in and see all of the passing, requirements, but then they could also see the comments on the ones that I would like, to have updated so they could say, okay. It should be more specific. So they can simply go into the requirement. They could edit it.
Maldari: And I can get a little more detail in this case. They could resolve the comment right from here. And they can resolve that comment right on the fly. It could say, save and close, commit, ok. And now at this point, the moderator could publish a new revision, and they could let the reviewers know that there’s a new version of that particular requirement. So let’s publish that after the change that was made.
And now they can actually see that there are two versions. Of the review. You can compare version one to version two, and you can see what’s changed in the requirements between the two versions. So a really nice way of seeing how the requirements evolve over time by virtue of the reviews.
The moderator also has some really nice views here in terms of statistics of the ability to see where the team is in terms of, you know, how far along they are in their review, how many they’ve approved, rejected, the time spent, on the reviews, They can email the participants, send reminders, email the approvers only. A lot of different information and statistics here. They can look at the types of comments that were put as part of the review so they can get a sense of how many changes they may need to make. Maybe there are just some questions and general comments, but if there are proposed changes or issues, you know, that’s that translates to work, the moderator may have to do.
So it’s really good information in terms of statistics here. All of the reviews that are in progress, completed, are stored in the review tab, all the Jama Connect, And so that at any given time, you can go back. You could take a look at your reviews, you know, see how the requirements evolved over time. Maybe a year later, you need to produce an audit report.
Maldari: Jama Connect allows you to create reports off on these reviews with all the comments and the states of the requirements. So very useful, for seeing how your requirements have evolved over time. A very powerful feature of the Review Center, but also as you can see, very easy to use and and very collaborative.
If you would like to learn more about how Jama Connect can optimize your product development processes, please visit our website at www.jamasoftware.com. If you’re already a Jama Connect customer and would like more information on the Review Center, please contact your customer success manager or Jama Software consultant.
https://www.jamasoftware.com/media/2023/08/FIF-Review-Center-1.jpg10801920Mario Maldari/media/jama-logo-primary.svgMario Maldari2023-09-01 03:00:022024-01-17 23:21:15Jama Connect® Features in Five: Review Center
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.
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.”
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.
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.
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.
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.
https://www.jamasoftware.com/media/2023/08/2023-08-10-cim-data-digital-thread-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2023-08-08 03:00:112024-01-17 23:29:21CIMdata: Digital Thread in Aerospace and Defense
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.
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.
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.
https://www.jamasoftware.com/media/2023/07/FIF-Baselines-2.jpg10801920Julie Goodner/media/jama-logo-primary.svgJulie Goodner2023-08-04 03:00:282024-01-18 10:29:06Jama Connect® Features in Five: Baselines
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.
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.
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.
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.
https://www.jamasoftware.com/media/2023/07/FIF-Framework-3.jpg10801920Vincent Balgos/media/jama-logo-primary.svgVincent Balgos2023-07-28 03:00:022024-01-17 23:39:01Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2
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.
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:
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.
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.
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.
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.
https://www.jamasoftware.com/media/2023/07/LLMK.jpeg5121024Marc Osofsky/media/jama-logo-primary.svgMarc Osofsky2023-07-26 03:00:342024-01-17 23:43:50How to Plan for Large Language Model (LLM) Adoption Within Your Engineering Organization
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.
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.
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.
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.
https://www.jamasoftware.com/media/2023/07/FIF-Framework-2.jpg10801920Vincent Balgos/media/jama-logo-primary.svgVincent Balgos2023-07-21 03:00:502024-01-17 23:47:09Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1
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.
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.
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.
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.
https://www.jamasoftware.com/media/2023/07/2023-Webinar-Recap-Med-Update.png5121024Vincent Balgos/media/jama-logo-primary.svgVincent Balgos2023-07-13 03:00:242024-01-17 23:51:58[Webinar Recap] Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®
