Tag Archive for: Product Development & Management

In this blog, we recap our webinar, “Accelerate Your ECSS Standards Compliance with Jama Connect®“. Click HERE to watch the entire thing.

Streamline your systems engineering efforts and ensure your products meet all the necessary industry standards.

Jama Connect® enables digital transformation with a more efficient and user-friendly approach to managing space systems development. It can optimize your systems engineering efforts and ensure your products meet all the necessary industry standards.

Learn how to incorporate regulations governing European space systems development into your Jama Connect solution. In this webinar, we discuss how customers can leverage a library of the European Cooperation for Space Standardization (ECSS) standards right inside their Jama Connect instance.

Cary Bryczek, Director of Aerospace & Defense (A&D) Solutions at Jama Software® along with fellow A&D experts Alisa Eikanas and Martijn Janssen, provide a high-level overview of the ECSS standards, along with best practices for leveraging them within Jama Connect, including:

  • ECSS Process workflows and how they align with processes managed within Jama Connect
  • Establishing an ECSS Library in Jama Connect to provide a Single Source of Truth
  • Explanation on how to tailor the ECSS requirements and leverage Jama Connect’s Reuse capability

Below is an abbreviated transcript of our webinar.

Accelerate Your ECSS Standards Compliance with Jama Connect®

Cary Bryczek: So welcome to today’s webinar. I am Cary Bryczek, the Director of Aerospace and Defense Solutions. I lead up a global team of industry and Jama Connect experts. For today’s webinar, two esteemed members of the team will be speaking. First to speak is Martijn Janssen. Martijn is a senior consultant at Jama Software. He has been working with PLM and requirements management solutions for over 15 years and is very proficient in not only Jama Connect but the Siemens industry software solutions as well as PTC Windchill. He currently works on implementing space-related systems such as satellites, launchers, and space-related components in the European Union for our Jama Connect partners. Martijn is a specialist in both systems engineering and information technologies.

We are also joined by Alisa Eikanas. Alisa is a senior consultant at Jama Software. She has over 15 years of experience supporting multi-discipline engineering teams and brings more than 10 years of experience as a business analyst to Jama’s customers. She works with our largest US government and commercial space customers in the US and she’s an expert at helping customers migrate data from legacy requirements tools such as Doors to Jama Connect. And with that, I’ll pass it over to you Martijn.

RELATED: Jama Connect® for Space Systems Datasheet

Martijn Janssen: Well, thank you for the introduction there, Cary. So welcome everybody to our webinar on ECSS. I’m very excited today to introduce you to the way we manage ECSS standards within Jama Connect. Over the past couple of years, we’ve been working with a lot of customers on managing ECSS standards within our solutions, and today we’re going to show you some examples of how we manage to do that.

So without further ado, I’m going to go over some of the ECSS standards, which include,  the use cases our customers face, and then afterward Alisa will dive into the system and show you some of those use cases in action in Jama Connect. Let’s dive into the presentation.

When we talk about ECSS, and I presume many of you here already are aware, but for those of you that are not aware of ECSS, ECSS is a European Cooperation and it’s a collaboration between the ESA, the European Space Agency, and many different other space agencies across the world to make sure that we have a single set of standards that we can use across companies working in the European space activities. Many of our customers around the world are looking to those standards, making sure they’re compliant with them, and working with those standards in different projects and at different levels.

So ECSS is a standard. You can find a lot of information on the website for ESA about the standards. They’re all there to be found if you’re not aware of them already. The way that ECSS is organized and set up is something you will see in the standards on the website itself, but we also have the organization within our Jama Connect application. So once Alisa’s going to show the demo, you will recognize a lot of those structures in Jama Connect.

RELATED: CIMdata: Digital Thread in Aerospace and Defense

Janssen: So when we talk about the standards, the standards are divided into branches and disciplines. So you will find, for example, the different branches on the top level there. So for example, the space project management branch or the engineering branch. Below those branches, you will find a lot of disciplines detailed per section. They are numbered in a specific way. Again, when we look into the demo, you will see a lot of those specific annotations come back and we maintained that same structure within Jama. So many of our customers use a subset or a number of these standards in their Jama Connect application to make sure they are compliant and they are working towards the standards that ESA has set for these specific projects. So the main structure in here is recognizable towards what is on the websites and in the organization of ECSS.

Outside of the actual organization of the disciplines and the branches, the disciplines themselves are even further, let’s say detailed in documents. All these documents fall into one of those disciplines. So for example, when we look at the discipline of system engineering, you can see a large number of documents below that, talk about different topics. So for example, on testing, on verification, on referencing coordinate systems, all kinds of documents describing the standard, what you need to do to be compliant towards those standards.

Now these documents are pulled into Jama Connect. And as you will see later on, we have all these documents available for you to start tracking and tracing compliance. So the structure from a branch to a discipline to all the documents is something that you will recognize in the demo later on by Alisa and where you can find and filter and search for certain topics that are numbered and maintained by the ESA.

To watch the entire webinar, visit:

Accelerate Your ECSS Standards Compliance with Jama Connect®


MDR/IVDR

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Regulatory Focus™, titled “MDR/IVDR Survey Shows NBs Have Increased Capacity” – originally written by Ferdous Al-Faruque and published on July 31, 2023.

MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity

A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus.

The European Commission published a survey of data from notified bodies (NB) conducted by the Austrian National Public Health Institute (Gesundheit Österreich GmbH), and research groups Areté and Civic Consulting on 25 July. The survey provides an overview of the MDR/IVDR transition process as of the end of March 2023. The results show that compared to October 2022, the number of MDR/IVDR applications and certificates has increased significantly.

Between 22 October 2022 and 31 Marodiech 2023, the number of MDR applications rose more than 40% from 8,120 to 11,418. The number of MDR certificates also rose almost 50% during that time from 1,990 to 2951.

The survey found that in October 2022 there were 22,793 products on the market with valid certificates under the Medical Device Directive and Active Implantable Device Directive (MDD/AIMDD) which means that applications for about half of those products have been submitted for transition by March 2023, and about 35% of MDD/AIMDD products submitted for transition to MDR were submitted since October 2022.

Similarly, the data shows the number of IVDR applications received by NBs has gone up more than 15% from 822 in October 2022 to 950 in March 2023, and the number of certificates they have issued for the products has gone up 24% from 268 to 331 during the same period.

“This progress is good news, [but] the survey results should be interpreted with some caution,” Sabina Hoekstra-van den Bosch, global director for regulatory strategy at TÜV SÜD GmbH and vice-president of Team-NB, told Focus.

RELATED: An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)

While the survey takes into consideration data through 31 March 2023, Hoekstra-van den Bosch says it doesn’t take into account any potential effect of the MDR extension that went into effect on 23 March 2023. She says it is likely the effects of the delay are only now showing up in the data and notes NBs have shared new data through the end of June with the European Commission which may offer a clearer picture. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)

“Everyone hopes and expects, that the number of applications will increase rapidly,” said Hoekstra-van den Bosch. “[But] another expectation is that the number of certificates will rise much more slowly than the number of applications, as Regulation 2023/607 gives time until 2027/2028 to finalize certification, while in the meantime manufacturers are allowed to keep the legacy device on the EU market.”

Hoekstra-van den Bosch says calculating the transition rate for products getting MDR certified is complicated and can be interpreted differently.

She notes that the current number of AIMDD/MDD products that need to be recertified is probably being underestimated since under MDR certificates will need to be given out for products such as class IIb implantable devices that require separate certificates. On the other hand, grouping basic UDI-DI products under MDR may also mean an increase in the number of certificates.

Hoekstra-van den Bosch says the MDR extension and publication of a Medical Device Coordination Group (MDCG) guidance encouraging manufacturers to not wait until the last minute are all good signs and if left unheeded may still result in bottlenecks for products getting recertified. (RELATED: Euro Roundup: EU answers questions about the extension of MDR transition, removal of ‘sell off’ periods, Regulatory Focus 30 March 2023)

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

“The [Austrian National Public Health Institute] survey shows some hopeful signs, but the ‘proof in the pudding is the eating,’” Hoekstra-van den Bosch said. “We are eagerly anticipating the publication of the next editions of the European Commission’s survey results.”

Gert Bos, executive director of the Qserve Group, says his main concern about products transitioning to MDR/IVDR has to do with communication between NBs and manufacturers.

“On the one hand many notified bodies indicate they can handle more applications, whereas manufacturers are not all speeding up their processes to get to the application phase,” he told Focus. “Meanwhile, companies on their second and third dossier may currently be waiting for 12 to 18 months to get feedback on their responses to the previous rounds of questions.”

Bos says there is plenty of guidance on how the new MDR system should work but there is still not enough guidance on what is considered sufficient evidence regarding clinical support, toxicity, biocompatibility testing, and general performance testing.

“The good news is that the structured dialogues between manufacturers and notified bodies are starting to bring clearer expectations,” he added. “So, we are going slowly in the right direction.”

Bos is also concerned that when applications do get feedback from NBs, they may contain deficiencies that could have been addressed in the first review round.

The survey sheds some light on the topic and lists the key reasons for why an MDR application was refused and shows some interesting trends.

In October 2022, the top two reasons were insufficient NB resources or because the application was outside the scope of the NB’s designation, with 61 and 66 applications being refused for those reasons, respectively. However, the top three reasons given for an application refusal in March 2023 were the wrong qualification or classification of a product with 74 refusals, the application was not complete with 80 refusals and the application was outside the NB’s designation with 208 refusals.

RELATED: European Union Medical Device Regulation (EU MDR): What You Need to Know

The number of refusals due to insufficient NB resources dropped to 31 which shows that NBs have started to significantly increase their capacity to handle incoming applications.

Bos is also worried that while global production processes have significantly improved in the past three decades, it has come to a halt due to delays in the MDR transition process.

“The problems rise to the level that such reviews on supply chain and production change approvals are starting to take priority over the more lengthy full MDR review processes,” he said. “This might in the coming 12 months fill the spare notified body capacity, in which case we’ll be walking straight into a further bottleneck when too many MDR and IVDR applications come in the second half of next year.

“Again the message is clear: Don’t delay your MDR and IVDR applications, but talk with your notified body about having the elements of the continued improvement reviewed in parallel,” he added. “It might free up the blocked production processes and will be useful in the full application as part of the new production has already been reviewed by the notified body.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Survey

© 2023 Regulatory Affairs Professionals Society.


Blog image for MIL-STD-810 showing engineer holding a clipboard.

MIL-STD-810: Ensuring Quality and Reliability in Challenging Defense Environments

From the desert to swamps to the frozen tundra, the United States Department of Defense (DoD) created the Military Standard 810 (MIL-STD-810) to enforce manufacturers deliver a product that will not fail in operational environments. This compliance regulation outlines environmental engineering considerations for testing equipment’s durability, performance, and quality in challenging and harsh environments. The blog will explain the significance of MIL-STD-810, its purpose, and how it impacts industries and consumers worldwide

Understanding MIL-STD-810

MIL-STD-810, widely used by commercial, non-military entities as well, prescribes a series of tests and procedures that have been created to measure the durability of equipment and its ability to survive in tough conditions.

Initially published in 1962, the standard has been regularly updated to keep up with technological developments and the varying environmental conditions. MIL-STD-810 thus serves as a useful tool for manufacturers, guaranteeing that their products can withstand the toughest circumstances.

The Purpose of MIL-STD-810

Defense contractors and manufacturers are required to meet the requirements outlined in this standard to sell their equipment to the U.S. military. MIL-STD-810 is used to ensure operability of equipment in conditions it may come across during its service life. The standard provides a broad selection of environmental factors and tests to go with them, allowing companies to find any weak points and make the necessary changes. By following this standard, it will help to improve the reliability and robustness of their product, resulting in successful harsh environment operation and a longer life in the field.

RELATED: Jama Connect® Airborne Systems Solution Overview

Key Environmental Factors Tested under MIL-STD-810

  • Temperature: Equipment is exposed to a broad range of temperatures, from frigid cold to blazing hot, to make sure its performance and security are up to the task in different climates.
  • Humidity: Checking the humidity level helps to guard the device from harm and ensure it functions properly in areas with high levels of moisture.
  • Shock: Devices are tested by subjecting them to mechanical shocks, such as drops and vibrations, to replicate real-world conditions and to evaluate their structural soundness and operation.
  • Vibration: The MIL-STD-810 outlines a variety of different vibration tests to simulate any transportation or operational movements that may affect the performance or parts of a device.
  • Sand and Dust: The capability of the equipment to resist being exposed to tiny particles such as sand and dust that are commonly seen in desert and arid areas is appraised.
  • Altitude: Checking the equipment’s operation at various altitudes determines its capacity in different air pressures, guaranteeing its dependability in high-altitude zones.
  • Solar Radiation: Evaluating the equipment’s response to solar radiation helps manufacturers understand its performance in outdoor environments with direct sunlight exposure.
  • Rain: Devices are tested to withstand exposure to rain and water, preventing water intrusion and potential short circuits.

Impact on Industries

    • Military and Defense: MIL-STD-810 is mandatory for military and defense contractors. Ensuring equipment works well in harsh conditions is vital for military operations. Compliance reduces the risk of equipment failure in critical situations.
    • Aerospace and Aviation: The aerospace industry uses MIL-STD-810 to make equipment for aircraft and space missions. The standard makes sure that equipment can handle extremes in flight and space conditions.
    • Consumer Electronics: MIL-STD-810, originally intended for military use, has been embraced by consumer electronics producers. This has resulted in the production of rugged smartphones, tablets, and laptops for those with a fast-paced lifestyle or who do their work in demanding settings.
    • Industrial Equipment: Industrial equipment and machinery often must endure difficult conditions, such as those found at construction sites and mining operations. By following MIL-STD-810 guidelines, manufacturers are able to produce sturdy and resilient machinery that can endure these types of settings, reducing the need for maintenance and repairs.

RELATED: Requirements Traceability Diagnostic

Conclusion

The MIL-STD-810 is of major importance in the assurance of the quality and dependability of equipment across myriads of industries. By undergoing multiple environmental examinations, companies can notice and tackle possible problems before their equipment is delivered to customers and stakeholders. This guideline has not only ensured reliability of military devices but has also played a role in the construction and production of commercial electronics and industrial machines.

In a world where technology is more and more ubiquitous, MIL-STD-810 remains a fundamental point of reference in managing the difficulties of hostile and unpredictable environmental conditions. Its impact will remain, prompting manufacturers to construct reliable and rugged devices that meet the requirements of the DoD and commercial customers across the world.

How Can Jama Connect® Help?

Jama Connect®‘s digital engineering strategy is essential for any organization seeking to increase efficiency and reliability. It serves as an essential bridge between teams, optimizing design and engineering processes. With its comprehensive system view and dependable source of information, it is an invaluable asset for achieving success.

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


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

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Reuters, titled “EU Seals New US Data Transfer Pact, But Challenge Likely” – originally written by Foo Yun Chee and published on July 10, 2023.

EU Seals New US Data Transfer Pact, But Challenge Likely

BRUSSELS, July 10 (Reuters) – The European Commission announced a new data transfer pact with the United States on Monday, seeking to end the legal uncertainty plaguing thousands of companies that transfer personal data across the Atlantic.

The move was immediately criticized by a non-profit group noyb, led by privacy activist Max Schrems, which said it would challenge the agreement.

The commission and the United States had been struggling to reach a new agreement after Europe’s top court annulled two previous pacts that underpinned the transfer of personal data across the Atlantic for services ranging from cloud infrastructure to payroll and banking.

The commission, the EU’s executive arm, said measures taken by the United States ensured an adequate level of protection for Europeans’ personal data transferred across the Atlantic for commercial use.

It said new binding safeguards, such as limiting U.S. Intelligence services’ access to EU data to what is “necessary and proportionate” and the establishment of a Data Protection Review Court for Europeans, address the concerns raised by Europe’s top court.

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

U.S. President Joe Biden welcomed the data transfer pact and said it reflected a “joint commitment to strong data privacy protections.”

EU justice chief Didier Reynders said he was confident of fending off any legal challenge.

“The principles of the data privacy framework are solid, and I am convinced that we have made significant progress which meets the requirements of the European Court of Justice case law,” he told a news conference. “I am very confident of fighting, defending the new data agreement.”

But Schrems said the latest revision was inadequate.

“Just announcing that something is ‘new,’ ‘robust’ or ‘effective’ does not cut it before the Court of Justice. We would need changes in U.S. surveillance law to make this work,” he said in a statement.

“We have various options for a challenge already in the drawer, although we are sick and tired of this legal ping-pong. We currently expect this to be back at the Court of Justice by the beginning of next year,” Schrems added.

RELATED: What is DevSecOps? A Guide to Building Secure Software

Lobbying group DigitalEurope, whose members include Airbus (AIR.PA), Amazon (AMZN.O), Apple (AAPL.O), Ericsson (ERICb.ST), Nokia (NOKIA.HE), Philips (PHG.AS) and Samsung (005930.KS), welcomed the deal.

“Data flows underpin the EU’s annual 1 trillion euros of service exports to the United States, and this decision will give companies more confidence to conduct business and help our economies to grow,” its director-general, Cecilia Bonefeld-Dahl, said.

Earlier this year, the EU’s privacy watchdog, the European Data Protection Board, said the latest data agreement still fell short and urged the commission to do more to protect Europeans’ privacy rights.

Europe’s top court scuppered the previous two deals after challenges by Schrems because of concerns about U.S. Intelligence agencies’ accessing European citizens’ private data.

Reporting by Foo Yun Chee; Additional reporting by Kanishka Singh in Washington; Editing by Philip Blenkinsop, Christina Fincher and Leslie Adler

The Thomson Reuters Trust Principles.


INCOSE Handbook Overview

In this blog, we discuss INCOSE’s System Engineering Handbook V5. To download this handbook, click HERE.

Empowering Engineers: Exploring INCOSE Systems Engineering Handbook V5

What is INCOSE?

The International Council on Systems Engineering (INCOSE) was founded as a collaborative effort to bring systems engineers together and provide them with resources to progress in their field. Their mission is to cultivate a strong network of professionals, supply educational materials, and create tools that will help systems engineers be successful. INCOSE is dedicated to elevating the global profile of the systems engineering (SE) profession.

RELATED: A Guide to Good Systems Engineering Best Practices: The Basics and Beyond

INCOSE Systems Engineering Handbook

According to INCOSE, the Systems Engineering Handbook “shows what each systems engineering process activity entails in the context of designing for affordability and performance. On some projects, a given activity may be performed very informally (e.g., on the back of an envelope, or in an engineer’s notebook); or, on other projects, a more formal response is required with interim products under formal configuration control.”

The handbook provides assistance for individuals of various backgrounds and experience levels, such as those just beginning their systems engineering journey, engineers from different disciplines needing to apply the principles of systems engineering, and experienced engineers looking for a handy reference.

INCOSE Systems Engineering Handbook V5

The newly released INCOSE Systems Engineering Handbook V5 is a comprehensive guide to the discipline of SE which outlines the current best practices and serves as an informative reference for understanding SE in terms of content and application.

Some of the topics included in the latest handbook include:

  • Elaboration on the key systems life cycle processes described in ISO/IEC/IEEE 15288:2023;
  • Chapters covering key systems engineering concepts, system lifecycle processes and methods, tailoring and application considerations, systems engineering in practice; and
  • Appendices, including an N2 diagram of the systems engineering processes and a detailed topical index.

DOWNLOAD: INCOSE Systems Engineering Handbook V5

Applying INCOSE Standards Using Jama Connect Advisor™

System engineers focus on making each of the individual systems work together into an integrated whole that performs as expected across the lifecycle of the product. In order to deliver successful products, they need the right user needs and requirements. Efficient, precise, and professionally written requirements form the foundation of the product development process so that various teams (design, software, and hardware systems) can all work together with a shared and clear understanding of the project goals.

Jama Connect Advisor™ is a state-of-the-art requirements authoring guide and optimizer powered by natural language processing for engineering that helps a system engineer or a product developer write effective, well-organized requirement specifications based on industry-accepted INCOSE rules and the EARS (Easy Approach to Requirements Syntax) notation.

To learn more, download our Jama Connect Advisor™ datasheet.


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


In this blog, we recap our webinar, “Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries”. Click HERE to watch the entire thing.

If you’re in the automotive or semiconductor industries – cybersecurity is likely top of mind.

During this informative session Effectively Managing Cybersecurity in Jama Connect for Automotive and Semiconductor Industries, Kevin Dibble, Principal Consultant at Reinnovate Consulting, and Matt Mickle, Director of Automotive Solutions at Jama Software®, offer insights on how the right tooling solution can make a difference in managing a cybersecurity case.

In this webinar, attendees will see exactly how to:

  • Define cybersecurity goals, requirements, and concepts
  • Conduct threat analysis and risk assessment
  • Establish traceability to the architecture design and verification/validation of cybersecurity measures
  • Document the cybersecurity case and manage changes
  • Identify and classify assets for the subject of the cybersecurity case
  • Discover how Jama Connect can help you optimize your cybersecurity processes and stay ahead in the Automotive and Semiconductor industries.

Below is an abbreviated transcript of our webinar.

Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries

Kevin Dibble: Well, first I’m going to talk about what we’re going to talk about, so these are the topics that we’re going to cover. And without reading this slide, really we’re going to cover the development life cycle of creating, the example we’re going to use is a 48-volt power assist system. You might also think of it as a battery management system. And so I’ll go over the agenda, but what you can see on the is we’re going to cover everything from the planning in the case through the TARA work and down through the left side of the V and some of the right side of the V activities as well. And here’s how we’re going to do it. First, to get everyone oriented to 21434, we’re going to talk about the standard itself briefly and highlight some of the benefits of implementing a cybersecurity case in a tool, in a requirement management tool.

Then we’ve got some workflows to look at, the steps of the development life cycle for 21434 from the perspective of an OEM and then again from the perspective of a tier one. And then Matt is going to show the work products, the traceability, and what we’ve talked about at the beginning actually in the tool in a built-out project for a 40 volt power assist system. And then we’ll finish with some takeaways. So that’s what’s on tap for today. And so I want to make the case for managing cybersecurity and the cybersecurity case and the work products in a requirements management tool. So I’m going to just look at each one of these points. The first item is to improve collaboration between OEMs, tier ones, and tier twos.

Jama Connect supports ReqIF, which can be used for bidirectional communication of requirements, item definitions, et cetera, as well as updates to those assets. And so it supports better collaboration. One thing that Jama promotes is this idea of trace as you go. So traceability is not an afterthought handled by a requirement engineer at the end of the project that takes weeks to implement on a complex project. It’s something that the engineers are doing as they’re creating the requirements tracing to parent requirements, design blocks for requirement allocation, et cetera. And so this tool supports that traces you go methodology along with some views of the progress of tracing.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Automotive

Dibble: The impact analysis is a powerful tool when you trace as you go and the requirements left and right side V model assets are linked together. Then running impact analysis reports as changes come in midstream in programs, which they do in automotive for sure. You get that as a benefit. Like I mentioned earlier, requirements allocation. So allocating requirements to design blocks or interconnecting the requirement management system to design tools and doing allocation in those tools like Design Architect gives you some powerful analytics like test coverage reports automatically generated. Also connecting the tools through connectors gives you a toolchain view instead of disjointed tool. And finally, Jama Connect offers some analytics that we’ll see some of these in the demo that will give you a very clear indication of where you are in the project, especially in terms of requirements that are allocated, tests that have been covering requirements, and so on and so forth.

So with that, I’m going to orient everybody to 21434 in terms of the V model, which it’s centered on, and two other standards that you may be more familiar with. ISO 26262 and Automotive ASPICE. And so just a couple things here. If you are familiar with these other two standards, you’ll see that 21434 fits nicely alongside and that was intended by the ISO folks that did the standard. They very much aligned it with ISO 26262, and really even in nomenclature. So whereas in safety we have safety goals, in security we have security goals, in safety, we have the HARA, the hazard and risk assessment. In cybersecurity, we have the TARA, threat, and risk assessment, and so on and so forth. And also the common supporting processes like configuration management, change management, project management, document management, even confidence in use of software tools that all of these standards rely on are again repeated and required in 21434.

RELATED: A Guide to Road Vehicle Cybersecurity According to ISO 21434

Dibble: So just some basic organization of the standard in terms of the V model and then we’ll look at it in one more view in terms… this is directly out of ISO. And at Jama, we’ve added some color coding and I’m going to explain that. And so if you’re not familiar with this view, 21434 is oriented by clauses and sub-clauses. And so you can see the clause here like clause five is organizational, that’s policy and tool management and quality management and things. And then clause six, et cetera, and on down, that’s how this is organized. Jama has capabilities that support these sub-clauses. And so we’ve used a color system here to highlight that. The sub-clauses that are colored in green are fully supported and in fact, recommended to implement in Jama. The yellow are optional, they could be implemented in Jama.

And for most of these, we have customers that are implementing these types of things in Jama, but they also use other systems to implement them. And then this kind of yellow-green is partially supported. Jama can support some of the requirements but not all. And then of course red is not recommended for support in Jama and it’s usually house and other tools or things like production tools, et cetera. Okay, so what Jama brings to the table in terms of capabilities to support these green and yellow items are document building and generation. So the document management functionality as well as the exporting functionality. As you’ll see in the demo, you can export what has been entered in a requirements tree or in one view can be exported into a more of a document-style view that perhaps suppliers or other people might want to consume.

It has built-in collaboration tools for reviewing, which is very important because 21434, like 26262 requires review records, and all the work products are reviewed. Traceability and impact analysis, I already talked about. VNV verification and validation with the test manager tool as well as interconnections to other tools and analytics. There’s a nice support for the right side of the V activities. Using a common tool does bring alignment between different engineering disciplines, whether it’s hardware, software in systems, or if it’s QA tests and V&V activities versus development activities. Release planning and coverage through dashboards and status metrics and then of course baselining and reuse and whatnot.

And so this slide shows all of the items from the previous slide that were recommended or are optional and just shows how they would look in a project tree format. Again, Matt’s going to go through most of these items for our 48-volt power assist item that we’ve built out. Okay, one of the important features of Jama Connect as well as any requirement management tool is the ability to develop traceability. Here we’re showing the traceability model, which is their traceability models come with the product, but they also can be customized. And then I’ve got a little animation here to show for cybersecurity, some of those standard parts and tying them back to the standard. So for instance, in the model, I don’t know, it’s small print, but you can probably see cybersecurity asset, attack path, damage scenario, threat scenario. Those all correspond to the TARA and here are the sections that those are discussed in.

To watch the entire webinar, visit:

Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries


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.