Tag Archive for: Requirements & Requirements Management
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 Engineering News-Record, titled “ENR 2024 Top 500 Sourcebook: Plant Tests Ocean Carbon Dioxide Removal” – originally published on July 16, 2024, and written by David Godkin.
Arup begins feasibility study of commercial-scale facility set for Canada site
Engineering has begun on a project its developers say could mark a new foray into ocean-based carbon dioxide removal.
The Quebec-based plant would be North America’s first commercial-scale, ocean-based carbon dioxide-removal facility, according to startup developers Equatic Inc., based in Los Angeles, and Deep Sky Inc., a Montreal firm. They say the facility would remove nearly 110,000 tonnes of carbon dioxide from the atmosphere annually—10% of which will be ocean-borne emissions. It also would produce 3,600 tonnes of hydrogen.
The plant technology uses a seawater electrolysis process developed at the UCLA Samueli School of Engineering’s Institute for Carbon Management. The system draws ocean seawater into an electrolysis chamber where carbon dioxide molecules are separated from the water and its natural acidity is neutralized. “This in turn allows the ocean water to draw down more CO2,” says Phil De Luna, Deep Sky chief carbon scientist and head of engineering. “These carbon emissions are some of the hardest to abate and most difficult to electrify.”
Extracted carbon dioxide is stored in the form of solid calcium and magnesium-based substances that the firm says could be used to produce construction materials.
The technology is based on a $20-million demonstration plant, called Equatic-1, which is set to commission next year in Singapore in collaboration with its national water agency, the developers said.The commercial plant will have easy access to the ocean-connected St. Lawrence River, and could tap into Quebec’s massive hydroelectric grid.
The facility would use less than 1.4 MW hours per ton of carbon dioxide, with removal cost estimated at less than $100 per ton by 2030, according to Equatic. Luna estimates the project’s cost at about $366 million. The plant may also be in line for carbon removal credits under a new U.S. Energy Dept. program, Equatic says, noting that such credits, as well as green hydrogen from this plant and future ones “have been pre-sold to companies such as Boeing, and further sales are ongoing.”
Engineering firm Arup has just begun a six-month plant feasibility study that is set to launch front-end engineering design work, environmental assessment and permitting, with a final investment decision estimated at the end of 2026.
If affirmed, construction on a 30-acre site would begin shortly after, with startup set for 2028. Deep Sky is currently exploring a plant location about 900 km northeast of Montreal, with a final site decision to be made by the end of 2024, the firm says.
Jama Connect® Features in Five: Cameo Systems Modeler Integration
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 Integration Series video, Gary Hayes, Senior Solutions Architect at Jama Software® – will demonstrate the Cameo Systems Modeler integration with Jama Connect®.
VIDEO TRANSCRIPT
Gary Hayes: Hello, and welcome to the Features in Five Integration series. My name is Gary Hayes, and I am a Senior Solutions Architect at Jama Software. Today, we will be walking through the Cameo Systems Modeler integration for Jama Connect. We make it possible for you to integrate Jama Connect with preferred best-of-breed software to achieve Live Traceability™ across the end-to-end development cycle. Live requirements traceability is the ability for any engineer at any time to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans. This enables significant productivity and quality improvements, dramatically reduces the risk of product delays, cost overruns, defects, rework, and recalls, and ultimately results in faster time to market.
Let’s start off today by looking at the two environments that we’ll be working with, Jama Connect and Cameo Systems Modeler. In Jama Connect, in our project here, we have a folder called swarming along with five requirements we’ve identified that we wanna be using. If we look over the Cameo System Modeler, you notice that we have the same folder, but we only have four requirements listed there.
Hayes: We can easily compare the items that exist in both environments, the four that you see here. We go into the plug-in that we’re using, identify the SysML repository, and we drill down on that folder that contains those requirements, and we can do a comparison between the source and the target. The plug-in will do the comparison for us. We don’t have to drill down and do a close examination.
When we get our results, we see that everything is green, indicating to us that the items in the folders that have been synchronized indeed match at this point. We can close this out for the time being, but you’ll keep in mind that we only have four requirements in Cameo, but we have a fifth one that does not exist currently in Cameo that is in Jama Connect. So we want to make sure that both environments do indeed match, and we can do that easily by dragging and dropping using that same plug-in.
We go back into our dashboard. We find our SysML repository, and we find our Jama Connect project that we’re working with. Drill down on that to find those requirements that currently are being synchronized between the two environments. We can easily see that we have the swarming folder along with its five requirements from Jama Connect and four from our Cameo environment. And to match those up, we want to drag and drop this into our Cameo environment.
And you’ll notice over here as it brings that over, you notice in the background, the cameo environment updates automatically to reflect the fact that we’ve brought a new requirement into the cameo environment. We can further confirm that by doing a synchronization check, doing that comparison once again at the folder level, compare our source and target, and hopefully, we’ll get all green one more time to show that the environments do indeed match up. But we don’t always have the luxury of dragging and dropping and never making any changes in any environment, so what we’ll want to do is make a change in one environment and push that from one side to the other. So let’s go into this individual requirement, broadcast to Swarm, and it’s annotated that it is indeed from Jama Connect. So we’re gonna remove that annotation in its title.
Hayes: We’ll go ahead and save that in our Jama Connect environment. You’ll notice that’s updated. Now we want to be able to show that same type of update. We’ll do that comparison first to see where we’re at because we never know when changes will occur. We can do our compare, make sure that comparison actually works, and flag us for a change. And indeed, we do. It comes up as pink or red, depending on your monitor, and flags us that there has been a there’s a discrepancy between the two environments. And you’ll notice too that it does the comparison. It doesn’t automatically make the change, and you can see that in the background. And in our Cameo environment, that change has not rolled over from Jama Connect to Cameo. So let’s make that change, permanent now. Let’s go ahead and do that push. We can push from our target to our source.
Keep your eyes on the Cameo environment in the background. As we make that change and it gets pushed over, you’ll notice that the name or the description of the requirement in Cameo indeed has changed, and so that has been updated automatically for us. We can do one last check with our compare tool, comparing source and target. So we get all green just for one additional factor of confidence that we get there, and you can see it there. So that’s one way to keep your Cameo and Jama Connect environments in sync using a plug-in.
Thank you for watching this Features in Five session on the Cameo Systems Modeler integration for Jama Connect. If you’re an existing customer and want to learn more, please reach out to your customer success manager or consultant. If you’re not yet a client, please visit our website at jamasoftware.com to learn more about the platform and how we can help optimize your development process.
https://www.jamasoftware.com/media/2024/07/FIF-Cameo-Integration.png10801920Gary Hayes/media/jama-logo-primary.svgGary Hayes2024-08-02 03:00:042024-09-26 14:13:10Jama Connect® Features in Five: Cameo Systems Modeler Integration
In this blog, we’ll recap our recent webinar, “Excelling in Requirements Management for Successful Software Delivery and Implementation” – Click HERE to watch it in its entirety.
Excelling in Requirements Management for Successful Software Delivery and Implementation
Are you interested in understanding the fundamentals of effective requirements gathering and analysis for the delivery of software?
In this webinar, Steven Meadows, Principal Solutions Lead at Jama Software®, discusses the challenges posed by traditional document-centric requirements processes to support customer-focused projects.
You’ll gain an understanding of:
Best Practices: Transitioning to more Agile and collaborative requirements management approaches to enhance project execution.
Case Studies: Real-world examples highlighting successful adoption of modern requirements management practices in vendor implementation projects.
Key Metrics: Learn how a requirements management platform can help improve project metrics for customer implementations.
Below is a preview of our webinar. Click HERE to watch it in its entirety.
The following is an abbreviated transcript of our webinar.
Meadows: Effective requirements management not only accelerates project timelines but also improves stakeholder collaboration and reduces the risk of project deviations.
An integral part of today’s discussion will be a deep dive into Jama Connect, a powerful tool designed to facilitate comprehensive requirements management. We’ll explore its features and functionalities that enable teams to capture, trace, and validate requirements throughout the implementation of software.
Whether you’re new to Jama Connect or seeking to optimize your current usage, this segment will provide valuable insights into leveraging the platform effectively.
Lastly, I’ll describe a case study that illustrates a successful implementation of requirements management strategies. This real-world example will demonstrate how an organization has overcome challenges, implemented best practices, and achieved tangible benefits using advanced tools and methodologies for the implementation of solutions.
By the end of this webinar, you should gain actionable insights to enhance your approach to requirements management, ultimately driving greater efficiency and success in your software delivery projects.
Now, before we get started, I’d like to briefly introduce myself and my background. With a robust background in requirements management, I bring over 10 years of experience in implementing software solutions across a broad spectrum of industries, successfully managing complex project engagement.
Throughout my career I’ve had the privilege of working closely with incredibly innovative and life-changing organizations, helping them navigate the intricate landscape of software implementation and delivery.
From defining clear and actionable requirements to optimizing workflows and ensuring seamless collaboration across teams, I’ve witnessed firsthand the transformative impact of effective requirements management.
Meadows: At Jama Software my focus has been on empowering teams to achieve their project goals efficiently and with precision. Whether it’s harnessing the full capabilities of Jama Connect or strategizing for complex project scenarios, my passion lies in delivering tangible results that drive innovation and enhance operational excellence.
Today I’m excited to share insights, strategies, and practical advice that can help you elevate your approach to requirements management. Together we’ll explore key principles, delve into best practices, and then cover strategies that can empower your organization to excel in software delivery and implementation.
I’d like to spend a moment quickly introducing Jama Software, the company that I represent. Jama Software provides the sweetest solutions that span the entire product and systems development lifecycle, from capturing and managing requirements traceability to enabling collaboration among diverse teams, Jama Software has engineered a platform that aligns with the evolving needs of today’s businesses.
You’ll see on this slide some of the verticals that we support, including regulated industries like medical devices and aerospace and defense, as well as pure software development and industrial manufacturing.
Some of the ways that we help our customers realize value is by reducing project cycle times, increasing process efficiency, and gaining visibility and control into implementation and development efforts.
Before we get to the main content of this webinar, I want to spend a moment just quickly defining what is meant by software implementation and delivery.
This is mainly related to the implementation of off-the-shelf software, as well as highly configurable applications. We work with a lot of vendors who implement their proprietary software for their customers, in particular, we have several customers in the benefits and HR space, healthcare, as well as other regulated industries including non-regulated industries. Although we’ll be touching on software development throughout this webinar, we’ll mainly be focusing on the implementation activities of applications, the challenges that come along with the implementation, and best practices to mitigate issues throughout the delivery of software for customers.
This has been an abbreviated transcript of our webinar.
https://www.jamasoftware.com/media/2024/07/Excelling-in-Requirements-Management-for-Successful-Software-Delivery-and-Implementation-1.png5121024Steven Meadows/media/jama-logo-primary.svgSteven Meadows2024-08-01 03:00:492024-07-31 09:38:30[Webinar Recap] Excelling in Requirements Management for Successful Software Delivery and Implementation
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 AECMagazine, titled “Cyberattacks: safeguarding contractors” – originally published on May 22, 2024, and written by Ben Wallbank.
Cyberattacks: Safeguarding Contractors
It’s every construction firm’s biggest nightmare: criminals taking control of their data and holding them to ransom. Ben Wallbank, Trimble, shares some best practices to mitigate cyberattacks
Cybersecurity and cybercrime often conjure up images of hackers in dark hoodies, sneaking in the digital back door. In reality, nearly 90% of corporate cybercrime, such as phishing or ransomware attacks, is a result of employee error.
The UK construction industry is no exception and could be an even greater target than other industries. Protecting massive amounts of data, including warranty and latent defect remediation periods, makes contractors attractive to cyber criminals. Cybersecurity is so crucial to construction that the National Cyber Security Centre produced a construction industry-specific guide, along with the Chartered Institute of Building (CIOB).
Cybercriminals who target the construction industry usually do so by accessing, copying, and sharing data illegally or by installing malware on a company’s computers and network, taking control of files, and holding them for ransom. It’s called ransomware, and it’s probably the most common and one of the most debilitating types of cybersecurity breaches in the construction world.
Each year, we hear of new cyberattacks, taking critical infrastructure offline and crippling construction businesses worldwide, including many here in Europe. These attacks cost billions of pounds a year and can cause whole cities, businesses, and services to grind to a halt.
UK contractors should follow these best practices to safeguard against cyberattacks and improve outcomes in case of an attack.
Create a business continuity plan
Preparing for the worst puts your business in the best position moving forward because you can act quickly and have more control of the outcome. A solid cyber security disaster plan can get quite detailed. It should be consistently reviewed, practiced, and updated to net the best results in case of an incident. At a minimum, a business continuity plan should include the following:
Name of a leader to act as a central resource to manage disaster recovery across multiple departments.
A communication plan for sharing key messages and managing crises with employees, clients, and additional project stakeholders.
A maintenance plan for a continually updated (and backed up) list of employee contact information and asset inventory.
A crucial aspect of any good cyber security plan is to make sure that everything is backed up, preferably on the cloud or physically on an offsite server that’s not on your network. Backups should be frequent and automated, so ask your IT provider to set them up so that they either happen in real-time (if you’re backing up to the cloud) or that they run daily after everyone has left the office.
Secure mobile devices
Mobile devices are more challenging to secure than other data systems, but just as critical. Utilizing an enterprise management platform, such as Cisco Meraki, allows you to maintain enterprise-level control over all of your devices. These kinds of platforms ensure that individual devices are still managed centrally, and contractors can limit software installation, track devices using GPS, disable devices, and more.
Protect software and servers
When it comes to software and security risks in construction, contractors should choose platforms and software providers that take security seriously. Granular permissions, user-friendly management systems, and multi-factor authentication, for instance, are all must-haves in any construction software.
By using cloud-based, connected construction software, contractors shift the responsibility of maintaining servers, ensuring SOC 2 Type II compliance, and data backup and storage. Project and business data backups happen automatically, providing daily protection, with costs often included or rolled into users’ subscription costs. New software features and security functionality are also rolled out automatically.
By coupling the backups with cybersecurity protections, cloud vendors use the latest technologies to thwart cybercriminals and provide an extra level of protection not otherwise achieved through in-house backups. When shopping for business software, make security one of your first discussion points.
Additionally, your web and email servers need to be properly protected to avoid online attacks. Physical network servers need to be secured, and you need to ensure that any cloud-based solutions you’re using also implement rigorous security protocols.
Cybersecurity protection in construction requires every employee at every level to be fully engaged and actively vigilant. There are several steps to take to make that happen:
Ensure all employees receive regular cybersecurity training, especially if online workflows or procedures change.
Welcome feedback from team members and update cybersecurity policies and processes as needed.
Counsel employees on everyday things to look for before opening email, like spelling and grammar errors, verifying sender’s email address, and never opening unexpected attachments.
Take the first step: get started
The most important step is the first one. The UK government offers two certifications – Cyber Essentials and Cyber Essentials Plus – that are crash courses in the basics to keep businesses safer from cybercrime. While they don’t replace a cybersecurity risk assessment, they will show you how to do one and how to select the security measures your business needs.
Anywhere your data is stored or used is a potential entry point into your company’s digital existence. It only takes one slip to allow malicious code or ransomware in, and once it’s there, it can cause millions of pounds worth of damage.
Jama Connect® Strengthens its Lead as the #1 Requirements Management Solution in G2®’s Summer 2024 Report
We are thrilled to announce that Jama Connect® has once again been named the overall leader in the G2 Grid® Report for Requirements Management Software for Summer 2024.
G2’s rankings are based on authentic user reviews and data gathered from online sources and social networks, analyzed through their unique v3.0 algorithm. The Summer 2024 G2 Grid® Report reflects scores calculated up until June 4, 2024.
In addition to being recognized as the top requirements management software, Jama Connect® has earned several other accolades for Summer 2024:
Overall Leader
Enterprise Leader
EMEA Leader
Europe Leader
Small-Business Leader
Mid-Market Leader
Momentum Leader
Learn more about the Summer 2024 G2 Grid for top Requirements Management Software products: DOWNLOAD IT HERE
Jama Software® is honored to receive this recognition, which highlights the value we bring to our customers, especially those moving from document-based approaches to complex product, systems, and software development. We are grateful to our customers for their valuable feedback on our product, services, and support.
Customer Feedback Highlights
“Jama [Connect] is not only a ‘document-oriented’ ALM tool, it gives the organization the ability to map the project structure the product structure making it an easy entry point for R&D folks. Configured properly, it is a real technical and regulatory ‘single source of truth.” – Frederic Fiquet, Director, Systems Engineering
“Product Design teams need a requirements management tool like Jama [Connect]. Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.” — Mark M., Mid-Market
Our commitment is to provide the best possible experience for our users, and being named the overall leader is a testament to their satisfaction and success with Jama Connect.
From all of us at Jama Software, thank you!
https://www.jamasoftware.com/media/2024/07/2024-07-25-g2-leader-summer2024.png512986Jama Software/media/jama-logo-primary.svgJama Software2024-07-25 03:00:312024-07-22 16:35:53Jama Connect® Strengthens its Lead as the #1 Requirements Management Solution in G2®’s Summer 2024 Report
How to Overcome Development Challenges: Proving Regulatory Compliance in Complex Product and Systems Development
As we enter the second half of 2024, development of complex products and systems often encounters the intricate web of regulatory compliance. From medical devices and automotive components to aerospace systems and software applications, ensuring adherence to stringent regulations is critical for both market access and consumer safety. However, proving regulatory compliance presents a multitude of challenges that can impede development timelines, inflate costs, and complicate project management. Fortunately, tools like Jama Connect® offer robust solutions to these challenges, streamlining the compliance process and enhancing overall efficiency.
The Challenges of Proving Regulatory Compliance
1: Diverse and Evolving Regulation
Complexity: Different industries are governed by a myriad of regulatory bodies, each with its own set of rules and standards. For example, the medical device industry must comply with FDA regulations in the U.S., CE marking in Europe, and various other international standards.
Evolution: Regulations are not static; they evolve to keep pace with technological advancements, emerging risks, and geopolitical changes. This continuous evolution necessitates constant monitoring and adaptation.
2: Traceability and Documentation
Traceability: Ensuring traceability from requirements through to testing and validation is essential for demonstrating compliance. This involves linking every design decision, change, and test result back to the initial regulatory requirements.
Documentation: Regulatory bodies demand extensive documentation as proof of compliance. Managing and organizing these documents can be a herculean task, particularly in large-scale projects with numerous stakeholders.
3: Collaboration and Communication
Interdisciplinary Teams: Complex systems development typically involves interdisciplinary teams, including engineers, designers, testers, and compliance officers. Effective collaboration and communication across these teams are crucial for ensuring that compliance is maintained throughout the development lifecycle.
Stakeholder Alignment: Aligning all stakeholders on compliance goals and processes can be challenging, especially in large organizations with decentralized teams.
4: Risk Management
Identification: Identifying potential risks related to regulatory compliance early in the development process is critical. These risks can stem from technological uncertainties, supply chain issues, or changes in regulatory requirements.
Mitigation: Developing and implementing strategies to mitigate identified risks requires a proactive and systematic approach, integrating risk management into the overall development process.
Jama Connect is a comprehensive requirements management platform designed to address the complexities of regulatory compliance in product and systems development. Here’s how it helps teams navigate and overcome these challenges:
“We develop complex products that require multidisciplinary work and V-cycle traceability. A tool like Jama Connect is required, and Jama Connect does the job well.” – Nicolas Ohlmann, CTO, CIXI
1: Centralized Requirement Management
Unified Platform: Jama Connect provides a centralized platform where all requirements, tests, and risks can be managed and tracked. This unified approach ensures that all compliance-related information is easily accessible and up-to-date.
Real-Time Updates: With real-time updates and version control, teams can ensure that everyone is working with the most current information, reducing the risk of compliance breaches due to outdated data.
“Jama Connect is a modern solution for requirement management. Other tools are either outdated, cheap, modern-looking clones of IBM DOORS, or insufficient in functionality.” – Requirement Manager, Professional Services Company
2: Enhanced Traceability
End-to-End Traceability: Jama Connect enables end-to-end traceability by linking requirements, design decisions, test cases, and validation results. This comprehensive traceability ensures that all regulatory requirements are met and can be easily demonstrated during audits.
Audit Trails: Detailed audit trails provide a clear record of all changes and decisions, facilitating smoother and more efficient compliance audits.
3: Collaboration and Communication Tools
Cross-Functional Collaboration: Jama Connect fosters collaboration across interdisciplinary teams through its integrated communication tools. This ensures that all team members are aligned on compliance objectives and can easily share information and updates.
Stakeholder Engagement: The platform supports stakeholder engagement by providing customizable dashboards and reports, enabling clear and effective communication of compliance status and progress.
“Investing in a good requirements management tool is a logical step to avoiding the common pitfalls of software development projects. Jama Connect provides the necessary tools to allow a team to manage huge amounts of requirements.” – Director, Solutions Delivery
4: Robust Risk Management
Risk Identification and Assessment: Jama Connect includes tools for identifying and assessing compliance risks, integrating risk management into the overall development process from the outset.
Risk Mitigation Plans: The platform supports the development and tracking of risk mitigation plans, ensuring that potential compliance issues are addressed proactively and systematically.
“I have used various requirements management tools throughout my career spanning over two decades and Jama Connect scores big when it comes to user interface. It is very easy to onboard the tool into the system with minimal training needs for the user groups. This does not belittle the functional core that a creator could do with the tool configuring it. I highly recommend Jama Connect for any organization working on safety-critical systems.” – Senior Manager, Biotechnology Company
Proving regulatory compliance in complex product and systems development is fraught with challenges, from navigating diverse and evolving regulations to ensuring traceability and effective collaboration. Jama Connect provides a powerful solution to these challenges, offering a centralized platform for requirement management, enhanced traceability, robust collaboration tools, and comprehensive risk management capabilities. With Jama Connect, teams can keep up with the ever-changing regulations thanks to our solutions developed and updated by our leading industry experts. By leveraging Jama Connect, teams can streamline the compliance process, reduce risks, and ultimately deliver high-quality, compliant products to market more efficiently.
“We use Jama Connect for requirements, risk, and verification/validation management, as well as integrating Jira and Enterprise Architect. Having traceability in one tool is going to be so helpful for our product development.” – Principal Systems Engineer, Health Care Providers & Services Company
Whether you’re developing cutting-edge medical devices, innovative automotive systems, or advanced software applications, Jama Connect can help you navigate the complexities of regulatory compliance and achieve your development goals with confidence.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by McKenzie Jonsson, and Mark Levitt.
https://www.jamasoftware.com/media/2024/07/Compliance-1.jpg10801920McKenzie Jonsson/media/jama-logo-primary.svgMcKenzie Jonsson2024-07-24 03:00:092024-07-22 13:58:44How to Overcome Development Challenges: Proving Regulatory Compliance in Complex Product and Systems Development
In this blog, we recap a section of our recent eBook, “Simplify Audit Documentation by Leveraging the Power of an Itemized Database” – Click HERE to read the whole thing.
Simplify Audit Documentation by Leveraging the Power of an Itemized Database
How to enhance efficiency, auditability, and stay ahead of the competition with Jama Connect® for Medical Device Development
In the current landscape of medical device and life sciences development — in addition to facing relentless pressures to innovate, remain competitive, and release quality products — medical device developers also must comply with rigorous regulations and standards for their products to be marketed, distributed, and sold in regulated markets like the United States and the European Union.
However, reliance on traditional documents or legacy document-driven systems like Cognition Cockpit and Polarion poses challenges for professionals, particularly those in roles such as quality assurance. This eBook delves into the transition from document-centric workflows to itemized databases, focusing on Jama Connect® as a solution to enhance efficiency and auditability in product development processes.
Traditional product development processes for medical device companies revolve around document-centric workflows. This section highlights the inherent limitations and complexities
associated with managing requirements, traceability, and change control solely through documents.
Challenges include:
Manual traceability matrices often lead to a time-consuming and error-prone process, making it challenging to maintain accurate and up-to-date links between requirements, design elements, and test cases, which are critical for regulatory compliance and product quality.
Version control issues can result in confusion, inconsistencies, and potential compliance risks, as stakeholders struggle to identify the most current documentation amidst multiple iterations, revisions, and parallel development efforts.
Difficulties working in an Agile workflow can hinder traceability and documentation, as the rapid pace of iterations and evolving requirements make it challenging to maintain clear and auditable links between user stories, tasks, and regulatory documentation, impacting the ability to demonstrate compliance and validation.
The absence of a single source of truth contributes to inefficiencies, as disparate document repositories result in data silos, inconsistent information, and difficulty in
reconciling different versions of documentation, leading to confusion and potential errors in audits or reviews.
Slow quality management processes can delay the verification and validation of documentation, impacting the timely detection and resolution of compliance issues, and the ability to demonstrate adherence to regulatory standards, potentially delaying product approvals and market entry.
The risk of errors escalating during iterative design phases grows as manual documentation processes and fragmented tools make it difficult to track and manage changes, increasing the likelihood of overlooked requirements, design inconsistencies, and compliance gaps that can surface during regulatory assessments and audits.
Central to this transition is understanding the inherent value of itemized databases like Jama Connect. This section explores the tangible benefits, including real-time traceability, proactive change management, and improved product quality.
By embracing itemized databases, organizations can:
Accelerate Product Development Cycles: By accelerating product development cycles, organizations can increase their market competitiveness and improve their ability to meet customer demands, while minimizing the risk of delays or missed opportunities caused by manual documentation processes.
Maintain Proactive Traceability: By maintaining proactive traceability, organizations can demonstrate compliance with regulatory requirements, ensuring transparency and accountability throughout the development process, while enabling faster detection and resolution of issues before they escalate.
Gain Visibility into Progress and Coverage: By gaining visibility into progress and coverage, organizations can identify gaps and redundancies in their documentation, prioritize requirements, and allocate resources effectively, improving overall product quality, and reducing the risk of compliance issues.
Proactively Manage Risks: By proactively managing risks, organizations can reduce the likelihood of errors and minimize the potential impact of issues, ensuring patient safety and reducing the risk of product recalls, legal liability, or damage to reputation.
Link Suspect Items and Manage Change: By linking suspect items and effectively managing change, organizations can streamline the change management process, minimizing the impact of revisions on other items, and ensuring that each change is properly reviewed and validated before implementation.
Maintain an Agile Workflow: By easily maintaining an Agile workflow, organizations can support their development teams, empowering them to collaborate and innovate effectively, while ensuring that their processes remain compliant and traceable throughout the development lifecycle.
Enhance Documentation: By enhancing compliance documentation, organizations can improve their ability to adhere to regulatory requirements and expectations, minimize the risk of non-compliance, and demonstrate their commitment to patient safety and quality outcomes.
Reuse Requirements: By reusing requirements and enabling release management, organizations can optimize their resources, reduce duplicative efforts, and improve their ability to deliver products that meet customer needs and expectations.
Automate Version Control: By automating version control, organizations can minimize the risk of errors caused by manual processes, streamline the review and approval of documentation, and improve their ability to manage multiple iterations and revisions while maintaining an accurate audit trail.
https://www.jamasoftware.com/media/2024/07/2024-07-11_simplify-audit-documentation-med-ebook-2-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2024-07-23 07:00:092024-07-23 09:23:40Simplify Audit Documentation by Leveraging the Power of an Itemized Database
The Top Six Things You Should Know About
In the quest for innovation, product testing, compliance, and safety certifications remain key to accessing markets and gaining customers. No one wants to buy a product, service, or process that hasn’t been thoroughly vetted by an independent body. In the context of global markets, few certifications carry the importance or significance of those from TÜV SÜD, but in the United States, the various companies that are part of the TÜV Association are not widely known. So, what is TÜV SÜD, and why is it so important to product development?
1: What does TÜV SÜD stand for?
“TÜV” stands for “Technischer Überwachungsverein,” which translates to “Technical Inspection Association” in English. There are several independent companies that are part of the TÜV Association; TÜV SÜD is headquartered in Munich and employs approximately 25,000 people around the globe.
2: What type of company is TÜV SÜD?
TÜV SÜD is focused on protecting people and the environment through rigorous testing, certification, auditing, and advisory services. The company helps ensure regulatory compliance of new and updated technologies, especially in automotive innovation and development, and it functions as a notified body in Europe for medical devices. The TÜV companies trace their origins back to the 1860s when they were first formed to oversee the safety of steam engines.
3: What is the difference between TÜV SÜD and TÜV Rheinland?
TÜV SÜD and TÜV Rheinland are different companies that both provide similar services. All TÜV companies are at least 25.1% owned by the TÜV Association. There are currently six main members of the TÜV Association, all of whom are denoted by the brand “TÜV” plus the regional suffix, such as SÜD or Rheinland. The other TÜV companies include TÜV Nord, TÜV Thüringen, TÜV Saarland, and TÜV Austria.
A TÜV SÜD Certification assures governing bodies and consumers that a product, service, or process has passed relevant safety testing and meets relevant compliance requirements. The certification process is rigorous and comprehensive and involves multiple steps, including steps to review requirements and establish processes followed during development.
5: Why is achieving TÜV SÜD Certification so important?
TÜV Certification is recognized internationally as a sign of quality and thorough review—similar to an ISO or UL certification. Although it originated in Germany, it is regarded globally as evidence that your product, service, or process has attained high standards of safety, quality, and sustainability. With a TÜV SÜD Certification, you can achieve access to additional markets and give your customers peace of mind.
6: Is Jama Connect® certified by TÜV SÜD?
Jama Connect received its first TÜV SÜD certification in 2016. Jama Connect is TÜV SÜD certified for developing safety-related products according to ISO 26262 (up to ASIL D) and IEC 61508 (up to SIL 3). Jama Software is the first vendor that is both SaaS and Agile to receive the certification. In 2019, Jama Software completed additional certification for Jama Connect as a software tool for the development of medical devices according to IEC 62304 and railway applications according to EN 50128.
Don’t neglect important certifications. Even if you are already pursuing other certifications, the TÜV SÜD Certification could be an important addition to your automotive, medical, or railway products and services. Jama Connect can help you meet the requirements tracing and process needs that will set you up to achieve the TÜV SÜD Certification and expand to new markets and customers. To learn more, contact us.
https://www.jamasoftware.com/media/2022/03/TUV-SUD-NEW.png5121024McKenzie Jonsson/media/jama-logo-primary.svgMcKenzie Jonsson2024-07-22 03:00:452024-07-22 15:21:19The Top Six Things You Should Know About TÜV SÜD
Jama Connect® Features in Five: Azure DevOps Integration
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 Integration Series video, Susan Manupelli, Solutions Architect at Jama Software® – will demonstrate the Azure DevOps integration with Jama Connect®.
VIDEO TRANSCRIPT
Susan Manupelli: Hello, and welcome to the Features in Five Integration series. My name is Susan Manupelli, and I’m a Senior Solutions Architect at Jama Software. Today, we will be walking through Azure DevOps integration. We make it possible for you to integrate Jama Connect with your preferred best-of-breed software to achieve Live Traceability™ across the end-to-end development cycle.
Live Requirements Traceability is the ability for any engineer at any time to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans. This enables significant productivity and quality improvements, dramatically reduces the risk of product delays, cost overruns, defects, rework, and recalls, and ultimately results in faster time to market.
Manupelli: Before I demonstrate the integration, I’d like to share a slide that depicts the flow of information. The top represents our process as defined in Java Connect through relationship rules. At the bottom, we’re depicting Azure DevOps. This slide illustrates an implementation task in the form of a user story that syncs up into Jama Connect, as well as a defect created in Jama Connect that syncs down to Azure DevOps. The beauty of this integration is that developers can stay in their tool of choice, in this case, ADO. Product owners can stay in Jama Connect, yet both sides have access to the details of the task. More importantly, the task and related status become part of what’s Live Traceable in Jama Connect. Let’s demo this.
Here we are in Jama Connect. The integration can be configured as a bidirectional sync, so it doesn’t matter whether I create the task in Jama Connect or ADO. First, we’ll decompose a software requirement into a development task that’s in the form of a user story. Here we have a login requirement software requirement. I’m gonna go ahead and add a related downstream user story, which will bring up the form to create a new user story. Notice the editor template feature in Jama Connect prepopulates these with standard user story verbiage. So as a user, I need to log in so that I can view my account. We’re gonna go ahead and set the status to new, and then we’re gonna save and close.
Jama Connect is prompting me to where I wanna save this, so I am going to go ahead and save this where the user stories live in my hierarchy. Notice that upon saving, automatically, the relationship widget indicates the fact that I have traceability, and I could see that traceability back to the software requirement. Within seconds, this user story will flow into ADO.
And you can see that it’s completed already. The integration URL has been populated, and I can navigate this URL, which will open up the item ADO. Let’s take a look. Here we are in ADO. You can imagine the developer has been assigned to implement the user story. They may add some context to the description. They may go ahead and add a comment, And they may go ahead and indicate that they’re starting to work on this user story by changing the status to active.
Notice that the developer can traverse a URL back to Jama Connect to see the requirements that are driving the user story. These links are handy, but the real advantage is the fact that the changes the developer made within seconds will be visible to anyone working in Jama Connect. Let’s flip back to Jama Connect and take a look. Notice the changes the developer made are now visible here in Jama Connect. The product owner can view and respond to the developer’s comment, and notice that the status has also been updated.
Manupelli: The updated status is reflected in a trace view that we can see here automatically, as well as any dashboard reports we have for user stories. So that’s Live Traceability in action. As a reminder, this thing can be configured by directional. So if your process varies and you create user stories in ADO, we support that use case as well.
Here we are in ADO. Let’s create a new user story. Let’s give it a title and give it a description, and let’s go ahead and save this. Within fifteen seconds, this user story will flow into Jama Connect. Here we are back in Jama Connect’s dashboard. Notice the widget showing these stories that are missing upstream relationships? That new user story has shown up here. Let’s open it.
Now let’s relate to existing and find the requirement that the user story fulfills, and we’re gonna go ahead and relate. Notice the traceability is updated automatically. This completes the traceability between the requirement and the user story.
Thank you for watching this Feature in Five session on the Azure DevOps integration for Jama Connect. If you are an existing customer and wanna learn more, please reach out to your customer success manager or consultant. If you’re not yet a client, please visit our website at jamasoftware.com to learn more about the platform and how we can help optimize your development process.
https://www.jamasoftware.com/media/2024/07/FIF-Azure-Dev-ops.png10801920Susan Manupelli/media/jama-logo-primary.svgSusan Manupelli2024-07-12 03:00:052024-09-26 14:58:44Jama Connect® Features in Five: Azure DevOps Integration
In this blog, we recap our webinar, “Bridging ALM and MBSE: Strategies for Seamless Integration” – Click HERE to watch it in its entirety.
Integrate Jama Connect® and Sparx Systems’ Enterprise Architect (EA) using LemonTree.Connect to align business and engineering objectives.
Join our experts Philipp Kalenda, Head of Consulting & Training at LieberLieber and Cary Bryczek, Director of Solution Architecture at Jama Software ® to discover how this powerful collaboration eliminates the gap between requirements engineering, system architecture, design, and product management.
You will gain a thorough understanding of these topics and more:
How Jama Connect®’s Live Traceability™ capabilities allow for seamless integration across best-of-breed tools.
How leveraging Jama Connect Traceable MBSE™ can act as a starting point for your MBSE efforts.
How to create a workflow for deriving systems architecture based on requirements from Jama Connect.
How LemonTree.Connect enables standard engineering domain practices for configuration management.
How to facilitate streamlined evidence that proves your architecture is satisfying requirements.
Below is a preview of our webinar. Click HERE to watch it in its entirety.
The following is an abbreviated transcript of our webinar.
Bridging ALM and MBSE: Strategies for Seamless Integration
Cary Bryczek: My name is Cary Bryczek. I’m the Director of Aerospace & Defense Solutions here at Jama Software. I’m really looking forward to speaking with you today on this particular topic and looking forward to Philipp’s presentation as well. So to kick things off, we are going to set … I just want to set the stage with some trends across the A&D industry that we’re seeing. I’ll talk about how those trends are creating challenges for chief engineers and describe what’s keeping them up at night. Then I’ll set the stage for Philipp’s presentation by showing you what Jama Connect’s Traceable MBSE™ looks like and how that’s designed to solve some of those challenges, and Philipp’s going to definitely take you on a deeper dive to show you how system models in Jama Connect interoperate.
In the aerospace and defense industry, developing a new system has a complexity that far exceeds commercial product development. For example, the FAA’s program to develop the unmanned aircraft traffic management system involves not just the pilot and his drone but is designed to enable autonomous and semi-autonomous operation of multiple aerial systems, including passenger and cargo delivery in a tightly integrated civil aerospace. The elements in blue that you see are all distinct systems of their own, and the new traffic management system needs to be able to integrate communications and data across all of those systems to provide this new capability.
Bryczek:Canopy Aerospace, they’re developing a low-cost reusable thermal protection system. Roccor AKA Redwire in Erie, Colorado, they’re developing a characterization of high aspect ratio booms for these large apertures and so many more. This ecosystem of partners and contributing to a whole brings its own challenges to the pool when trying to collaborate, share data, and execute common systems engineering processes. Like the NASA’s Cislunar and Artemis initiatives for space exploration, they’re focusing on operation and survivability.
In the defense domain, we’re seeing all sorts of cases in unmanned aerial systems as well to aid tactical situations and help with strategic planning. The underlying theme of these large systems is the integration and the collaborative approaches to developing these different weapon systems and aerospace systems in very constrained environments.
So from a strategy perspective, what are these agencies trying to really do? Government agencies and aerospace and defense companies are always evolving their strategies to be able to deal with this complexity and to help streamline their engineering processes. For example, the Department of Defense (DOD) has published a new adaptive acquisition framework. This pathway is intended for large-scale traditional hardware acquisitions to facilitate rapid and iterative development and delivery of software capability to the user.
Bryczek: In 2018, the Digital Engineering strategy outlines a vision to modernize how the department designs, develops, delivers, and operates, as well as sustains systems securely and safely. Their vision is to connect people, processes, data, and capabilities across an end-to-end digital enterprise. The International Council on Systems Engineering (INCOSE) published its recent Vision 2035 document, and it is intended to inspire and guide the strategic direction of systems engineering, the practice of systems engineering for the global systems community.
MOSA, the Modular Open Systems Approach, it uses a system architecture that allows major subsystem components at the appropriate level to be incrementally added, removed, and replaced throughout the lifecycle of the major system. The DOD’s systems engineering and architecture group is focusing on modernizing the systems engineering practice. They’re leveraging capabilities from CERC. They’re using MOSA to build systems that can be upgraded and to incorporate new technology faster to respond to emerging threats.
When we look at this in a little bit larger view with this new modernization of the systems engineering approach, the DOD has moved away from visualizing its process using a V model in favor of what truly takes place from a process standpoint, which is that modern systems engineering is highly cyclic. You can see the outermost ring is as close to that old V model, where a concept definition is in the upper right, it moves the system definition through architecture and design and over to V & V and back-to-start around on the next cycle.
What’s important is that there’s a strong emphasis on measuring not just the system being built, but the process that’s building the system, your system’s engineering process and that data and models are at the heart of it all. To the fullest extent, models should be used in favor of documents and data should inform decision-making.
What is the industry saying? There’s a challenge to using data-driven approaches and models. The DOD has highlighted there’s a lack of an integrated approach to the implementation of these systems engineering focus areas, and it’s creating a delay in the full implementation of the digital transformation, which is necessary to ensure relevant guidance and skills.
Bryczek: Continuing to use legacy tools and approaches is what is making integrated approaches not possible. What is necessary is to take a federated approach to data across the tool ecosystem and to use tools with more robust APIs, and modern architectures that are standards-based. An MBSE approach requires an integrated approach to connect the system models, architecture, and requirements to the program teams the software teams, and the hardware teams. It doesn’t mean to use a siloed system modeling tool and expect those teams to be able to consume and understand that model.
What we hear quite often is, “How do I achieve the benefits of MBSE when no other engineers can access model parameters that they need for downstream decision-making?” Those with technical oversight, chief engineers who have technical oversight and responsibility for program success, executing MBSE, or even just traditional systems engineering commonly raise the following questions, “How do I know if the architecture and system requirements are satisfying all the needs? How do I know if a change in the architecture will impact testing? How do I know if a change in the architecture will impact downstream hardware or software teams? How do I detect unallocated systems architecture and requirements?”
So the question of, “How do I achieve the benefits of MBSE when no other engineers can access model parameters?” can be answered by using traceable MBSE. Now, the reality at most companies is that the end-to-end systems development process is fragmented into domain-specific tools and spreadsheets that have no built-in collaboration. Now, this leads to fragmented requirements traceability and requires significant manual effort through emails and meetings and sometimes luck to try and prevent delays rework, or cost overruns.
Most companies have come to accept the situation as an unchangeable reality given the lack of a single platform to enable this entire process, nor a method to integrate spreadsheets and desktop tools. Using Traceable MBSE, the system model in the modeling tool is joined with the Jama Connect model. Jama Connect is continually calculating traceability and coverage and provides scores that can be used to identify high-risk areas that can be drilled into to determine corrective actions. The system model can detect those changes and the modeling engineers can take the corrective actions.
