Tag Archive for: Jama Connect Platform

this image shows a graduation cap and a clock, indicating this pot will teach visitors quickly on the topic of space systems.

Jama Connect® Features in Five: Space Systems Framework

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Cary Bryczek – Director, Aerospace & Defense Solution at Jama Software® – we will explore the Space Systems Framework available for Aerospace & Defense teams in Jama Connect.

VIDEO TRANSCRIPT

Cary Bryczek: Hi. I’m Cary Bryczek, Director of Aerospace & Defense Solutions at Jama Software. In this video, I’m going to introduce you to our Space Systems Framework available in Jama Connect. In this video, we will explore the benefits of using our pre-built template to get started with managing requirements, test cases, and architecture using our best practices inspired by industry standards and guidance from organizations like NASA and the European Space Agency.

With space systems exponentially growing in complexity, shortening development timelines due to mission need and customer demand, and cost reductions influencing the capabilities able to be delivered with the final design. Programs need to be able to get started quickly and begin the real work of engineering the system. Development and engineering tools need to be robust enough to tackle that complexity easy enough to deploy and then not get in the way of the real work of engineering the system.

Jama Connect and our Space Framework come preconfigured with a ready-to-use template. The framework is comprised of a requirements data model that provides requirements leveling and decomposition, a verification of validation data model that provides traceability to those requirements, an architecture data model that provides mechanisms to support systems architecture system functions, and allocation of requirements, and a data organization method that follows industry guidance with the best practices of data organization in Jama Connect. Let’s see what this looks like in Jama Connect.

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

Bryczek: The Space Framework comes with two pre-built requirement data models. The one I’m showing now represents a full spacecraft product breakdown structure. The example shows how Jama Connect can handle the complexity of a full NASA or ESA space program. The requirements data model allows needs and requirements to be flowed down and fully traced from the stakeholder expectations, to the concept of operations, to system level requirements, down to segment element subsystem and component requirements.

This trace data model, what Jama calls the relationship model, provides a mechanism to enforce consistency and creation of data as well as a consistent method to trace that data. This allows you to do faster analysis, measurement of expected versus actual traceability, complex filtering, and easy trace matrix generation and reporting.

The left side of the screen is the exploratory and is where the data is organized. The Space Framework comes with this pre-built spec tree ready for users to start authoring content right away. You can see that it too is organized hierarchically from the highest level of abstraction at the mission level and then down to the component level. You can navigate this traceability in the tree as well.

We recognize that not every space system will be developed by a single entity that requires this combined breath of customer implementing requirements and those of the implementing organizations. Your organization might be merely developing only a component of a larger space system. For this, we have a second Space Framework for integrated systems. Let’s look at this one more closely.

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Bryczek: In this CubeSat example that comes with the framework, it’s easy to see how the data is organized in the exploratory in a system, subsystem configuration. Inside each of the subsystems, you can see the specific requirements, their verifications, architecture, and design descriptions. Traceability throughout the entire project can easily be analyzed at any level.

What I’m showing is the traceability from the stakeholder expectations all the way down the decomposition tree. I can see the system requirements verification and validation test cases. I can see the architecture, the subsystem requirements, and even the test runs, these real-time trace views not only show requirements decomposition, but test covers as well as allocation to architecture.

The framework supports, as I said, not just requirements, but architectures, V & V, even risk management and security. We’ve preconfigured the way you organized that here in the tree. So if I wanted to see the system architecture, I am able to see all of the elements that are going into making up the system architecture of this CubeSat I can also see how I’ve organized by system subsystem within the tree itself. That enables me to reuse easily and do variant management in this particular CubeSat security.

So, if you need to have security requirements or if you need to do heavy cyber security and you wanna import things like NIST 800 you can easily do that kind of a thing. Risk management threats and risks moving the development cycle with security earlier in that life cycle is a big deal, or understanding how safety is influencing the design. We easily allow you to track risk management and threat analysis in Jama as well.

The intent of this is to provide ready-to-use solutions based on customer feedback, industry trends, and best practices, such as those of ESA and NASA. This enables engineers to tackle the complexity of space systems develop faster and collaborate at the speed of need. If you would like to learn more about how Jama Connect can optimize your product development processes, Please visit our website at www.jamasoftware.com. If you are already a Jama Connect customer and would like more information on the Space Framework, please contact your customer success manager or Jama Software consultant.

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

Co-workers portraying modern requirements management.

In this blog, we re-cap our eBook, “The Strategic Transition: From Word and Excel to Modern Requirements Management” – Download the entire thing HERE.

The Strategic Transition: From Word and Excel to Modern Requirements Management

Unless your organization’s business model is built on a foundation of inefficiency, you should not be using disparate documents for managing requirements. Whether it’s Microsoft Word, Excel, or a combination of both, trying to wrangle your product’s requirements soley in documents carries a lot of risk and will gradually eat away at your company’s bottom line.

There was a time when using disparate documents wasn’t such a problem for managing requirements, but as products grow in complexity, those days are fading. Many companies no longer produce products that contain just hardware or software; today it’s likely a combination of both, increasing development complexity exponentially.

Integrating hardware and software means teams spanning various engineering disciplines all need to stay aligned throughout development, especially when things like safety standards and regulations are involved.

Using documents alone, will simply not be up to the task of meeting today’s complex products, systems, and software development. When you need precision, context, and accountability for your requirements, a modern requirements management solution is really the only answer.

In this eBook, we’ll detail some of the reasons why you’ll want to leave disparate documents for managing requirements in your rearview. You’ll also get an overview of the benefits you’ll gain by moving to a purpose built software solution for requirements management.

What is requirements management?

To level set, requirements management is the process of gathering, analyzing, verifying, and validating the needs and requirements for a given product or system being developed.

Successful requirements management ensures that completed deliverables meet the expectations of the stakeholders.

Learn more

Five Drawbacks of Documents

Microsoft Word and Excel serve many purposes, and have done so for decades. And, in terms of requirements, for early-phase documentation and coordinating simple projects, they still remain effective tools.

As the complexity of product and systems development grows, so does your list of requirements. And teams need solutions that provide simple and streamlined collaboration, not jumbled — often quickly outdated — comments and suggested edits. Teams need to be able to instantly connect to globally distributed colleagues to facilitate real-time feedback and make smarter decisions with full context around requirements. Documents simply aren’t up to the challenge.

Here are some of the key limitations for a document-based approach for storing requirements:

1. Documents are tedious to maintain

Anyone who has ever managed requirements with documents and several collaborators is familiar with the unique pains of this approach. Whether it’s Word documents that are hundreds of pages long or Excel spreadsheets with thousands of lines, keeping them fresh with updates and free of errors is extremely cumbersome and time-consuming.

2. Versioning difficulties

Collaborating on any kind of important documentation can be painstaking, especially when there’s an enormous amount of requirements involved. For instance, when reviewing requirements, it’s incredibly easy for two people to be looking at different versions of the same set of requirements, and not even know it. And even if it’s a cloud-based version of requirements, there are still plenty of opportunities for someone to unintentionally change something without getting prior approval, and that adjustment not being accounted for in future versions. Plus, online/cloud-based documents do not automatically create different IDs and versions for each requirement or highlight the changes between versions.

3. No traceability

There’s so much room for error through email chains and undisclosed updates. It’s incredibly simple, for example, to miss a tiny change that could have critical ramifications upstream or downstream.

4. Reviews are time consuming

Without traceability, review cycles with an enormous document of requirements are extremely long. You’re likely looking at scheduling lengthy meetings or passing around version after version, pulling team members away from other priorities, which is not ideal when you’re focused on getting to market quickly. And if you’re trying to manage reviews asynchronously, collaboration becomes tricky and timelines are likely to get pushed as people’s schedules shift.

5. Exhausting collaboration between teams

Sharing constantly evolving requirements files among multiple stakeholders and different teams throughout the development and testing process is risky, frustrating, and time-consuming. And with your customer demanding a perfect product, system, or software delivered ASAP, you can no longer afford that kind of inefficiency.

In this eBook, The Jama Software® Guide to Requirements Traceability, we’ll highlight the importance of tracing requirements without the headaches and risks of a traceability matrix in Excel, but also how to do so in a way that sets your organization up for future success. Learn how Live Traceability™ helps teams:

    • Reduce the risk of delays, cost overruns, rework, defects, and recalls
    • Comply with industry standards with no after-the-fact manual effort
    • Allows engineering teams that continue working in their chosen best-of-breed tools
    • Increase productivity and satisfaction of engineers

Get it here

Seven Benefits of Using a Requirements Management Solution

Despite rising product complexity and regulation, most development teams do not have a sophisticated requirement management system in place. In fact, according to a recent survey, almost one third of teams have no system in place and rely on formal processes with email, documents, and shared spreadsheets.

Another 52% manage their requirements with a system which is not meant for managing requirements, like Application Lifecycle Management (ALM) or Product Lifecycle Management (PLM) systems. And only 15% have chosen to invest in a formal dedicated requirement management solution.

Using a dedicated requirements management solution allows teams to stop getting bogged down on processes and start innovating. For example MediSync, reports that investing in Jama Connect® has saved 80% of the time that would have otherwise been spent on meetings, sorting through versions of Word documents and emails, and consolidating feedback in review cycles.

Grifols saved around 80 hours per project in medical device development when using the Jama Connect Review Center. And RBC Medical (now known as Vantage Medtech) saved around $150,000 per project by improving team collaboration and workflow efficiencies using Jama Connect.

Here are some of the benefits you’ll get from investing in a solid requirements management solution:

1. Version and change management

A solid requirements management solution will maintain a history of each change made to every requirement. You’ll also be able to record the rationale behind each change, and refer back to a previous version of a requirement if necessary. Some solutions contain a change proposal system that links change requests directly to requirements. And, with a formal requirements management solution, you’ll always know you’re looking at the most recent version of the requirements.

2. Requirements attributes

With a strong requirements management solution, you should be able to record several descriptive attributes for each requirement. The right requirements management software should generate several system-defined attributes such as the date the requirement was created, its current version number, and the person on the requirements should be able to view these attributes, even if only a couple of individuals are allowed to update the attributes’ values.

3. Facilitate impact analysis

A requirements management solution enables requirements tracing by letting you define links between different types of requirements, requirements and different subsystems, and individual requirements and related system components (designs, modules, tests, and user documentation). These links help you analyze the impact that the proposed change will have on a specific requirement. It’s also very helpful to have the ability to trace each functional requirement back to its origin or parent so that you know exactly where every requirement came from. And some solutions use a traceability link to raise suspect flags to a linked item whenever a change is made, so you know exactly what needs to be reviewed after a change.

4. Track requirements status

Collecting requirements in a database lets you know how many discrete requirements you’ve specified for the product. And tracking the status of each requirement during development helps communicate how things are coming along to those across the organization. So, a project manager has good insights into prior states if he or she knows that, for example, 55% of the requirements committed to the next release have been verified, 28% have been implemented but not verified, and 70% have not yet been fully implemented. This type of information gives the project manager information to anticipate the project’s progress, and relay the message to stakeholders accordingly.

5. Control access

A requirements management solution should let you bring as many people into the system as possible, and grant them permission to access the specific parts they’re working on. This helps teams across the organization feel more invested in the product being developed and its progress.

What if you didn’t have to compromise? A growing number of organizations are exploring and adopting product development solutions that manage the complexity that comes with designing connected systems. This allows them to:

  • Build higher-quality products
  • Get to market more efficiently
  • Capitalize on opportunities faster

Download this Buyer’s Guide: Selecting a Requirements Management and Traceability Solution to better understand the challenges you’re up against and thoughtfully consider potential requirements and test management solutions. Plus, get tips on how to get the buy-in you need to undertake the kind of change necessary to succeed with complex product development.

Get it here

6. Facilitating communication with stakeholders

A requirements management solution should allow team members to discuss requirements issues electronically through a threaded conversation, in one central location, as opposed to having communication spread out across various platforms. It will automatically trigger email messages and notify effective individuals when a new discussion entry is made or when a specific requirement is modified. And it should allow team members to reach out to each other, but also contact non-project members and external users.

7. Recycling/reusing requirements

Storing requirements in a central database facilitates the reuse of them in multiple projects or sub-projects. And requirements that logically fit into multiple parts of the same product can be stored once and referenced whenever necessary to avoid duplicates. This saves a lot of time and reduces the chance of making errors.

Leveraging Jama Connect® for Effective Development of Combination Products

Developing combination devices, also called combination products, such as inhalers or injectables, is a complex and interdisciplinary endeavor that lies at the intersection of pharmaceuticals, biologics, engineering, and medical science. These innovative devices are designed to provide patients with a more convenient and effective way to administer medications.

One of the primary objectives in developing combination products is to enhance treatment adherence, particularly in chronic conditions where consistent medication delivery is critical. By combining medication with a delivery system, patients can receive accurate doses, reducing the risk of errors and ensuring that the therapeutic benefits are maximized.

Image Showing a Combination Product Types Chart

Requirements management tools such as Jama Connect® have become indispensable assets in the product development process, helping streamline the complexities involved in producing safe and effective combination devices.

This article explores how Jama Connect can prove invaluable in areas such as reuse/variant management, hazard library maintenance, compliance standards, integrated risk management, and expeditious reviews, making it an essential tool for engineers and developers in the medical field.

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

Simplify Complex Traceability

  • The development of combination devices often involves integrating a complex hierarchy of requirements, from User Needs and System Requirements, down through Risk Evaluations, Subsystems, and Verifications and Validations. Maintaining proper traceability throughout the product development lifecycle is a vital component of developing safe and effective products. Jama Connect allows development teams to simplify this process by enabling Live Traceability™ between development artifacts. Product development team can establish traceability, ensuring that every design element, from the software components to physical hardware, aligns with the initial requirements. This robust traceability is essential for regulatory compliance and safety, particularly in the medical device industry.

Requirements Reuse

  • Combination product teams often face added levels of complexity in their development process as they work to adapt product designs to the specific requirements of multiple applications, and the diverse regulatory demands across markets. Jama Connect allows for the efficient reuse of requirements, hazards, risk assessments, and verification testing across projects, enabling development teams to take a platform approach to their development process, track the evolution of variants, assess the impact of change across all their systems, and ensure compliance with international standards is maintained. This significantly reduces redundancy, minimizes errors, and speeds up development cycles.

Compliance with Standards

  • Combination devices must adhere to stringent regulatory and quality standards, such as ISO 13485, ISO 14971, ISO 11608, and FDA requirements. Jama Connect aids in aligning the project with these standards by providing tools for document control, validation, and verification. It supports the creation of audit trails, which are essential for proving compliance. This streamlines the certification process and minimizes the risk of non-compliance.

Integrated Risk Management

  • Risk Management is a critical component of developing combination products, but development teams often struggle with highly disconnected risk management processes. Jama Connect’s integrated risk management capabilities allow teams to proactively identify, assess, and mitigate risks throughout the development process, and ensure Live Traceability between risk evaluations and controls. Risk matrices, failure mode and effects analysis (FMEA), and other risk management methodologies can be seamlessly integrated into the development workflow, ensuring that potential issues are addressed early and efficiently.

Hazard Library Management

  • Safety is of paramount importance in the development of combination products. Maintaining a comprehensive library of hazards, both known and potential, is crucial to mitigate risks effectively. Jama Connect facilitates the organization and accessibility of this critical information. It allows engineers to define, document, and classify hazards and their corresponding risk assessments. This central repository ensures that hazard management remains an integral part of the design process and that safety remains a top priority.

Efficient Reviews

  • Efficient and timely reviews are vital in the development of combination devices, as they help uncover issues, assess design tradeoffs, and ensure alignment with requirements. Jama Connect simplifies the review process by offering a collaborative platform for stakeholders to provide feedback, track changes, and sign off on design decisions. This collaborative approach fosters effective communication and reduces the time required for reviews, expediting the overall development cycle.

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Developing combination products, which encompass a wide range of medical innovations, requires a multidisciplinary approach and careful management of various elements. Jama Connect is a powerful requirements management tool that streamlines the development process in multiple ways, from facilitating requirements reuse and variant management to managing hazard libraries, ensuring compliance, and integrating risk management.

By leveraging Jama Connect, product development teams can significantly improve their efficiency, reduce errors, enhance safety, and expedite the development of combination products while maintaining the highest standards of quality and regulatory compliance.


Image showing badges awarded by TrustRadius to Jama Connect.

Jama Connect® is Awarded the TrustRadius Triple Crown for Requirements Management Software!

Jama Connect® has gained recognition as an outstanding solution on TrustRadius, solidifying its position as a leading platform for requirements, risk, and test management.

With its intuitive interface, robust features, and exceptional customer support, Jama Connect has received the following prestigious awards in 2023: Best Of, Feature Set, Pricing, and Relationship.

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

This recognition underscores Jama Software’s unwavering commitment to delivering a reliable and efficient solution that empowers teams to drive innovation and achieve exceptional results.

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

As the leading provider of requirements management software, Jama Software is proud to receive recognition for our commitment to enabling multidisciplinary engineering organizations developing products, systems, and software to maximize their success. We value the feedback from our clients who have used Jama Connect and are committed to providing them with the best support, resources, and expertise to help them succeed.

“Jama Connect is a solid framework for systems engineering that can integrate many design processes into a single tool. At a fundamental level, it is a great tool for handling requirements management and traceability but offers a variety of other features such as risk management and verification and validation. For someone who works in the medical device industry, the tool also complies with CFR requirements for electronic approvals and can be validated for such use.”

-From review collected and hosted on TrustRadius – User in Engineering, Medical Devices Company

“I’m VERY likely to recommend Jama to a colleague because they’d struggle to get anything done without using it! That’s the tool we’re using for Req Management now, so I recommend to my colleagues that they get amongst it!”

-From review collected and hosted on TrustRadius – Ian Webb, Systems Engineering Technical Writer – Enphase EnergyElectrical & Electronic Manufacturing

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


Image showing a graduation cap and clock, symbolizing that this content will teach someone about reuse & sync in a quick session.

In this video, we’ll discuss the reuse & sync capabilities in Jama Connect.

Jama Connect® Features in Five: Reuse & Sync

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Zeb Geary – Principal Professional Services Consultant at Jama Software® – will go over the reuse & sync capabilities for requirements management in Jama Connect.

VIDEO TRANSCRIPT

Zeb Geary: Welcome to this segment of Features in Five. I’m Zeb Geary, a Principal Consultant at Jama Software. In this video, I’ll explain how your team can reduce time to market and improve quality by reusing and synchronizing requirements and other content in Jama Connect.

Teams often struggle to build on existing work when requirements and tests are spread across documents and systems. Lacking a live trace, they must manually identify and copy related content, increasing the risk of rework and gaps. Additionally, teams tend to lack visibility across efforts, causing necessary changes to not propagate across reuse content, potentially impacting quality and disconnected product design efforts.

Jama Connect simplifies and enhances the process of reusing requirements and verifications by allowing you to copy selected content with its containers and its traced items. Synchronization ensures visibility and enables key use cases such as parallel product definition, common content libraries, and product variance. Let’s look at reuse and synchronization in Jama Connect.

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Geary: Here in Jama Connect, I’m looking at a project that we would consider a library or potentially a platform of 150% of our requirements. For this example, I’ve started building out the requirements and verifications for a new Jama Connect project, but I’ll be incorporating some standard or common requirements from this project. And through reuse, I’ll save time and ensure consistency with the platform.

I want to bring these common display requirements into my project from the platform. I see that these requirements have related verifications, and I want to bring these into my project as well. I’ll go ahead and select to reuse this folder. The reuse window shows me what I’ve selected for reuse and provides me with important options that reveal the significance of this capability. The first option determines if I will enable synchronization. If enabled, Jama Connect will establish a connection between the result of my reuse and its source so that I can monitor them for differences. I have options to include or exclude tags, attachments, and links, and to form a relationship to my source item from the resulting copy.

The final section of options determines how I will handle related content outside of my selection. Recall that the selective requirements have downstream verifications that I want to make sure I bring into my project. I will select the option to include related content and to mirror the relationships in my project. This saves me a lot of time since I will not have to recreate these relationships in the new project and removes the risk of missing verifications related to my selected requirements.

Finally, I indicate where I want to reuse the content to. I’ll select my project and I can have Jama Connect copy the project hierarchy as well into my target project, or I can select an existing location in my project. I selected my location and I will reuse with Sync.

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

Geary: In my project, the common display requirements have been reused with their related verifications. Here in my project, I can use Sync View to see how my reused items may differ from the library or any other project using these common requirements. Let’s check out this folder called “Scheduling.”

I can see from our sync items view that I’m in sync with the platform, meaning there’s no difference there, but we have a parallel effort that I am out of sync with. In Compare View, I can see exactly how we differ and bring those differences, if necessary, into my project. Sync View provides me with the visibility I need to make sure I’m working with the latest applicable requirements in my project. Here I will update the requirement text and I’ll create the missing requirement in my project. Now my project and this parallel effort are in sync.

As we have seen, reuse and synchronization is a key feature supporting critical requirements and verification activities. A Jama Software consultant can help you properly support your process with reuse and sync. If you have a Success Program with Jama Software, see our offerings under Improving Your Process to request assistance from a consultant. Your customer success manager can help you learn more about Jama Software Success Programs. If you would like to learn more about how Jama Connect can optimize your product development process, please visit our website at www.jamasoftware.com.


This image shows a lightbulb lit with a money sign, symbolizing saving money on requirements management software.

Economic Climate Have You Rethinking Your Software Spend? Five Reasons to KEEP Your Requirements Management Software

It’s a conversation in every news cycle, boardroom conversation, and dinner table right now – the economy. And while the economy is a dynamic force that ebbs and flows, much like the tide, the state of our current economy has most of us on edge.

In the world of product, software, and systems development, cost-cutting measures are often at the forefront of organizational decision-making. When times get tough, the temptation to trim budgets and eliminate seemingly non-essential tools and processes becomes more pronounced.

For organizations developing complex products, one such area that might be under the cost-cutting axe is requirements management solutions. While it may seem like an easy way to save money, ditching your requirements management solution could have unintended and detrimental consequences on your bottom line.

In this post, we will explore five compelling reasons why eliminating your requirements management solution may not be in the short- or long-term best interest of your organization — or your bottom line. Without a formal requirements management solution, you open your organization up to:

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

1. Increased Revisions and Rework

Requirements management solutions are designed to streamline the process of capturing, analyzing, and managing project requirements. Without a dedicated tool for this crucial task, the likelihood of misunderstandings and miscommunications regarding project requirements increases. This can lead to more frequent revisions and rework, consuming valuable time and resources that could be better utilized elsewhere. The iterative nature of resolving requirements without a structured system often results in delayed project timelines and increased costs, offsetting any initial savings resulting from cutting your purpose-built requirements management solution.

2. Communication Breakdowns

Clear and effective communication is the backbone of any successful project. A requirements management solution provides a centralized platform for stakeholders to collaborate, document, and discuss project requirements. When this system is removed, communication can become fragmented and disorganized. Critical details may be lost or misinterpreted, leading to confusion among team members. Efficient collaboration is compromised increasing the risk of errors, hindering productivity, and negatively affecting overall project success.

3. Difficulty in Requirement Traceability

Traceability is a fundamental aspect of requirements management, ensuring that each requirement is linked to its source and can be traced throughout the product or software lifecycle. Without a dedicated solution, maintaining this traceability becomes a laborious and error-prone manual task. This lack of traceability can result in gaps, inconsistencies, and the inability to ensure that all requirements are met, potentially leading to very costly project failures, recalls, or compliance issues.

4. Compliance and Audit Risks

For organizations operating in regulated industries, compliance with industry standards and regulations is essential. A requirements management solution often offers features that help in maintaining compliance by documenting and tracking adherence to specific guidelines. Eliminating this tool may expose your organization to increased compliance and audit risks, potentially resulting in fines, legal complications, and damage to your reputation.

5. Impaired Decision-Making

The right requirements management solution will provide valuable insights and analytics that aid in informed decision-making. These tools can offer data-driven metrics, progress tracking, and performance indicators. Without this data-driven approach, decision-making becomes subjective and less efficient, potentially leading to costly errors and suboptimal project outcomes.

One of the main causes of rework, delays, and cost overruns in product development is the creation of new requirements late in the process. This is a well-known risk in product development, but what management practices can empirically be shown to reduce this known risk?

Using our proprietary database of metadata from over 50,000 complex product development projects, we were able to determine that the Traceability Score™ is an empirical method to reduce late requirements. In fact, teams that maintain a high Traceability Score reduce the burden late requirements have on their project by 67% compared to teams with low traceability scores.

With this knowledge, our recommendation is that practitioners measure and monitor the Traceability Score™ of their projects to resolve issues early and ensure that the risk of late requirements is kept to a minimum.

RELATED: The Strategic Transition: From Word and Excel to Modern Requirements Management

 

While the prospect of cutting costs by eliminating a requirements management solution may seem appealing initially, it’s clear that the long-term consequences outweigh the short-term benefits.

It’s important to carefully consider the potential risks associated with such a decision and evaluate the true cost savings against the potential detrimental impact on project success, compliance, and overall organizational efficiency. Balancing cost-saving initiatives with maintaining essential project management tools is crucial for achieving sustained success in today’s competitive business landscape.

Download our eBook to access easy-to-use, interactive ROI calculators and to learn more about the value of requirements management. These calculators will help you argue for the financial advantages of continuing to invest in a requirements management solution even in uncertain economic times. >> Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense.


Integrating Jama Software with Jira

Q&A: Integrating Jama Software with Jira for Better Product Development

We often receive questions around how Jama Connect® integrates with other product development tools. And while many legacy requirements management tools only integrate with their own tool suites, Jama Connect was purposefully built to integrate with top tier solutions, allowing teams to leverage best-of-breed tools across the entire product development lifecycle. Integrating Jama Software with Jira is no exception.

When development solutions are disconnected, information and teams become siloed, often leading to rework, miscommunication, and missed deadlines. That’s why Jama Software offers a host of integrations to enhance and strengthen development workflows. One of the most popular being our integration with Atlassian® Jira®.

To comply with industry standards, engineering teams in regulated industries must achieve requirements traceability across siloed teams and tools. Most software development teams have chosen Jira as their preferred task management tool and refuse to switch to cumbersome legacy ALM tools that would negatively impact their productivity. Attempts to try and achieve Live Traceability with Jira or Jira plugins break down quickly as the complexity of approvals, versioning, change impact analysis, baselines and variant management overwhelm a task management approach.

The best-practice approach implemented by hundreds of Fortune 1000 companies and startups alike, is to use Jama Connect to create Live Traceability™ across a best-of-breed toolchain including Jira or Azure DevOps for the software development team. This approach simultaneously solves the need for Live Traceability AND causes no disruption to existing tools, processes, and even field names for the software development team in Jira.

Using Jama Connect to manage requirements and Jira to monitor tasks separately is a viable solution for many product companies. Those forward-thinking businesses who take advantage of the powerful integration between the two see much stronger management of complexity, traceability, requirements, and progress tracking.

Since we get this question so often, we’ve written about it on our blog and covered it more extensively in a webinar, explaining the benefit of connecting these two best-of-breed tools.

Watch the full webinar for an in-depth look at the Jama Connect integration with Jira:
Managing Hardware & Software Product Development Complexity with Jama Connect & Jira

In the webinar, Mike Frazier, Principal of Frazier Executive Consulting, and Kevin Andrewjeski, Senior Account Executive at Jama Software, walked through some of the key benefits of a Jama Connect + Jira integrated system.

At the conclusion of the presentation, Frazier and Andrewjeski fielded questions from those in attendance. Below you’ll find a slightly abbreviated version of the question-and-answer session on integrating Jama Software with Jira.

Q: We want to start using a more Agile approach or more Agile methodologies. Do Jama Connect and Jira support an Agile methodology?

Kevin Andrewjeski: Jama Connect, as a tool, is process agnostic. We have customers that are very Agile — internally we use Jama Connect in an Agile way. Also, we have customers that are hardware focused. And then, of course, we have folks that are blended with hardware and software, with waterfall and Agile mixed in together.

So, the tool is very configurable and flexible to fit into your preferred process rather than having your teams try to fit into a process that we are identifying for you.

RELATED: Minimize Late-Stage Changes by Linking Requirements and Tests with Development Activity

Mike Frazier: To add to that, from a transition perspective, at Xilinx we used a waterfall approach for IP development. It might take a year or so to build out a brand-new piece of IP. But then, as we iterated that product — typically Xilinx would release its software on a quarterly basis, and therefore our IP could be updated on a quarterly basis as well — we decided to use Agile for some of those “incremental releases.”

What that did for us is it helped us do smaller chunks of work in a more predictable, smaller amount of time for those quarterly updates.

Now, I will caution companies about how it does require a mindset change, as I’m sure there are those of you that have transitioned from a waterfall approach to an Agile approach. It’s not at all classic, like a waterfall approach.

It requires people who need to be trained on what it’s like to develop an Agile environment. And if there are people within your company who are Agile program managers, take advantage of that.

If not, take advantage of companies that can help you develop your Agile skills. It’s not something you should do without being aware that it does require a shift in mentality for all the stakeholders involved.

RELATED: How to Achieve Live Traceability™ with Jira® for Software Development Teams

Learn more about the benefits of integrating Jama Software with Jira in our blog post, “How Combining Jama and Jira Improves Your Development Process.”

Q: Product managers and systems engineers are the obvious targets of the requirements management tools and processes. What about the rest of the engineering team? Architects, designers, developers, for example?

MF: The beauty of it is if you use a tool like Jama Connect to capture your requirements, and you’re soliciting input and feedback throughout, and using some of the abilities of the tool throughout the requirements capture process, and you’re engaging with your architectural team, potentially all the way down to lead level engineering teams, it creates more of a sense of inclusion. And it also creates that collaboration and communication.

I think maybe the typical thought process people go through is you create a marketing requirements document and you “throw it over the fence” to engineering for feedback.

What tools like Jama Connect will do, as long as you include the appropriate stakeholders from not only engineering but other downstream organizations such as production or operations, and other organizations that typically aren’t involved in the requirements management process, you’re going to get all of that stakeholder feedback earlier in the development cycle and minimize surprises. So, I think it could be used for all aspects of the organization.

RELATED: How to Create Live Traceability™ With Jama Connect and Jira

KA: To add on to Mike’s comments, from a Jama Software perspective, it’s a way to encourage collaboration. So, you may have core users in marketing, engineering, depending on your structure, that are really the people creating these requirements and managing these requirements, but you might have a broader group of people participating in providing feedback and a clarification.

And so those users, that we term as collaborators, can actually participate in the system without a paid license so that you’re really encouraging that feedback and collaboration, especially cross functionally, with the ultimate goal of making sure you’re building the right product.

Developing complex products with partners requires a common vision. Learn how better requirements management helps better facilitate the collaboration process by watching our webinar.

Q: Can you speak to some of the training, some of the education that you offer on how to create effective requirements?

MF: Jama Software does a very good job offering white papers and other resources around best practices for requirements, test, and risk management.

Personally, the way I get involved in requirements management with my clients is typically during the product development lifecycle. Most of my clients are looking for help on the front end of the development cycle, where they’re struggling with a scenario where you have one-third of bug escapes due to poor requirements.

Q: Does Jama Software provide a solution for the Jama/Jira integration?

KA: Yes, we offer a seamless solution for integrating Jama Software with Jira , as well as Jama Connect to other tools. The integration technology itself is from our integration partner (TaskTop) not something we create internally. But we can help you get configured and installed as part of the implementation of Jama Connect, so they’re coupled together.

Learn more about integrating Jama Connect and Atlassian Jira to improve visibility and alignment across your development teams and lifecycle by downloading our datasheet.

Image showing a clock with a graduation had, symbolizing that the viewer will be learning about SaMD.

In this video, we’ll discuss the Software as a Medical Device (also known as SaMD) framework in Jama Connect.

Jama Connect® Features in Five: SaMD Framework

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Romer De Los Santos – Senior Consultant at Jama Software® – will go over some highlights of the Software as a Medical Device (also known as SaMD) framework in Jama Connect.

VIDEO TRANSCRIPT

Romer De Los Santos: Hello. My name is Romer De Los Santos and I’m a senior consultant here at Jama Software. In this video, we’ll go over some highlights around Jama Connect’s new Software as a Medical Device (also known as SaMD) framework.

Anyone who has worked developing medical device software has struggled with balancing the creation and maintenance of the required documentation with the day-to-day struggle of developing and testing software. And because software cycles are highly iterative, they are incompatible with traditional waterfall development.

Jama Connect’s new SaMD framework is designed to help alleviate the burden of documentation so that your team can focus on development. This purpose-built framework allows users working on both simple and complex software projects to use Jama Connect right out of the box. Its design was born from over 20 years of hands-on experience developing medical device software.

Some highlights of this framework include:

  • Templates like Software Development Plans that are designed to be compliant with IEC62304. These documents come with a customizable report that you can modify with your own branding.
  • Built-in risk analysis designed to be compliant with ISO14971 that takes advantage of Jama Connect’s built-in look-up table feature.
  • A new SOUP/OTS item type is designed to capture information about third-party developed software components in compliance with the FDA’s guidance on Off the Shelf, (or OTS)Software Use In Medical Devices.
  • A new External Resource item type to capture and trace items tracked outside of Jama Connect.

Let’s take a closer look.

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

De Los Santos: The SaMD framework gives new medical device manufacturers a great starting point. It has been designed to with regulations like IEC 62304 and ISO 14971 in mind. However, manufacturers are still required to define their own quality management system.

Although regulations specify what needs to be documented, there’s no universally accepted document name or format. Jama Connect can be configured to use your company’s own jargon and the document templates required by your own quality management system.

The framework is organized into four major components in a document-centric structure. This means that items are organized into documents rather than by function.

This structure is easier for new users to recognize and work on. It also facilitates the generation of documents that will be submitted to the system of record of your choice.

For your convenience, the framework includes customizable export templates for multiple documents. You can change the logo, headers, footers, fonts, and style of your document to match your company’s branding requirements.

Project-level documentation includes planning documentation such as the Software Development Plan and Software Verification Validation Plan.

IEC 62304 has specific requirements for software development plans that have been incorporated into the template for your convenience.

RELATED: Jama Connect® Customer Validated Cloud Package for Medical Device and Life Sciences

De Los Santos: While IEC 62304 does not require a separate Software Verification or Validation Plan, it does require specific information about how verification and validation will be performed. This document template includes sections for the required information.

System-Level Documentation includes documents that define the requirements, testing, and design of the whole system. It can include items like User or Stakeholder Needs, Design input documents, Product Requirements Specifications, and Software Architecture documents.

Sub-System Level Documentation can be organized into individual components, software or otherwise. Each component includes the requirements, test cases, and design documentation.

The Risk Management Plan, FMEAs, and risk analysis are centralized in the Risk component. By default, the FMEA and risk analysis are organized as you would see them in Excel. It also takes advantage of Jama Connect’s built-in look-up matrix feature to do your risk calculations.

Of course, not all medical device software projects are multi-component projects. A software project that consists of a single software component doesn’t need to have system and subsystem-level requirements. In this case, remove the System Requirement and System Architecture item types from the relationship diagram to create a single-level structure.

OTS/SOUP components are documented through a new item type that is specifically designed to capture the information specified in the FDA’s guidance on OTS Software Use in Medical Devices.

RELATED: EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights

De Los Santos: Jama Connect allows you to trace the specific sections of your design documentation that utilize third-party components to this item type. This makes tracking where these software components are used easy.

Finally, we’ve added a catch-all item called External Resource. External Resource items allow you to trace items that may be tracked outside of Jama Connect. This can be items like instructions for use, labeling, package inserts, specifications, schematics, and pretty much anything else you need to trace.

I hope you got a lot out of this quick look at the new SaMD framework in Jama Connect. If you want to learn more about Jama Connect and how it 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 Medical Device Software, please contact your customer success manager or a Jama Software consultant.

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


Image showing industry experts who speak about insurance product development.

In this blog, we recap our webinar, “Bridging the Gap in Insurance Product Development”. Click HERE to watch the entire webinar.

Looking to bridge the gap in your insurance product development?

Learn how carriers can utilize Jama Connect® to increase efficiency across the development process and more effectively deliver high quality products on time and on budget.

During this informative session, Lianne Warford, Senior Business Analyst at LHW Consulting, and Steven Meadows, Principal Solutions Lead at Jama Software®, discuss how this newly available insurance framework and dataset streamlines and simplifies product development for the insurance industry.

Gain insights into:

  • Overcoming common insurance industry challenges
  • Leveraging the benefits of a modern requirements management solution
  • The new insurance framework available in Jama Connect, with off-the-shelf elements for enhanced workflow and efficiency

Discover how Jama Connect allows carriers to innovate, bring products to market quicker, and ultimately better serve their customers.

Below is an abbreviated transcript of our webinar.

Bridging the Gap in Insurance Product Development

Steven Meadows: Okay, so today, we have a pretty packed agenda. We’re going to be starting off or Lianne’s going to be talking about legacy insurance requirements management. Following that, we’ll be talking about how you can overcome some of the common insurance industry challenges, some of the important considerations for streamlined insurance product development. After that, I’ll be talking about the problem with legacy tools and insurance product development, followed by best practices for an effective development strategy. I’ll then be providing a brief introduction to Jama Connect for Insurance, very high level overview. And then finally, we’ll end with a solution key takeaways and questions. And with that, Lianne, go ahead.

Lianne Watford: All right, thanks Steven so much. I appreciate this opportunity to work with Jama Software. I want to get started today with talking about different scenarios, two main scenarios where requirements are needed in the insurance industry. So we have the policy administration systems that automate the day-to-day operations of an insurance company. And the second area is the new and enhanced insurance products and services that insurance companies want to undertake. So let’s just dive right in. It has a lot of information, so let’s get started. So from the policy administration system, while every insurance company’s unique, processes that all insurance companies share for the day-to-day operations are quite common. And I’d venture to say that you would have to look long and hard to find an insurance company today that doesn’t have some type of policy admin system, whether it be a homegrown system that they’ve done themselves or utilizing some other type of software vendor.

RELATED: Traceable Agile – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Watford: So if you take a look at the areas that are common, you have your policy administration. So every insurance policy starts with a quote and there’s quite a bit of information that needs to be captured. You’ve got your insured name, address, and contact information among others. You have information about the risk that’s being insured, whether it’s a house, a car, or business. And there are specific details for each types of risks that have to be captured to provide an accurate rate for the policy. You’ve got your coverages that are needed for each of the specific types of risks like property damage and liability coverage, and there’s lots of information that needs to be captured around that as well. And then once the policy is bound and issued, there’s several different types of documents such as declaration pages, rating sheets, etc, that have to be generated and are dependent on specific policy details.

And while those requirements are related to the insured risk and coverages, there’ll be an entirely different set of requirements for the output that describe the information about both the static and the variable data that’s needed to be printed. So that’s a ton of information right there. If you haven’t really captured it, we’ve just hit one bullet point under the policy admin. And then you’re always going to have the need to make a change to the policy at some point. And those are processed as endorsements. And while some of these requirements can be reused from the quote bind and issue process, there’ll also be certain rules for different types of endorsements that’ll need to be captured as separate requirements. And then you also have the output that’s specific to those related endorsements. Again, more stuff. And then you also have the processes around your cancellations and reinstatements for underwriting reasons, and you’re going to have documents that go along with that as well.

RELATED: A Wise Investment: Requirements Management and Traceability Solutions During an Economic Downturn

Watford: All of those have to have requirements for the related output and downstream effects as well. And then hopefully the insured’s going to be happy with your service at your company and they’ll want to renew the policy for another term. So yep, there goes another set of specific requirements that are associated with the processing of the renewal as well as the output that’s associated. That’s a big mouthful of information. But then the next step you’ve got to do is collect the money for the premium that’s generated on the policy. So you gather requirements for down payments if you require them. You also provide payment plan options to allow them to pay, and installments are all at one time, so there’s lots of requirements around that. Then you also have special rules for nonpayment of premium cancellations and reinstatements that are different from your underwriting cancellations and reinstatements, different set of requirements.

And then you have to process refunds and collections. Again, and there’s all types of outputs that go along with these processes as well that have to be documented. And then of course, the big thing for an insurance company is your annual statement. That’s your accounting for what insurance companies do. And so, there’s all kinds of requirements for your annual statement, annual statement lines, and statistical reporting. Again, a ton of requirements. And then last but not least is your claims administration, which is the reason that you actually have insurance, right? So that if you need to make a claim, so you have your requirements around first notice of loss and then there’s a ton of information that they have to capture, lots of things that they have to do in that area as well. Come out and inspect, assign agents, all different types of processes for your claims.

And then you ultimately want to make a payment to the insured when it’s needed and processing of reinsurance if your company handles reinsurance. So that’s a mouthful of information and lots of requirements that maybe a lot of people don’t think about when it comes to insurance day-to-day operations. And then when you move on to thinking about the company wants to have new and enhanced insurance products and services. So you’ve got new products that you want to offer, you have new states and lines of business and coverages that you want to move into. And then if you want to enhance existing products, you’ve got rate changes, additional coverages you want to provide. And then there’s all kinds of interfaces, imager, quick rater, all types of interfaces into insurance policy admin systems that help integrate your business. And then not to mention, you’ve got to upgrade those existing interfaces because softwares are continuously evolving.

To watch the entire webinar, visit:
Bridging the Gap in Insurance Product Development


Image showing presenters of a webinar about Automotive and Semiconductor Development compliance

In this blog, we recap our webinar, “Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development”. Click HERE to watch the entire webinar.

Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software®

During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards.

Key takeaways from this webinar:

  • Learn about available diagnostic offerings in Jama Connect, such as: ASPICE, ISOS26262, and ISO21434
  • Learn about the benefits of diagnostic offerings, how they will expose risks to compliance, and which one is best for your organization
  • See firsthand how Jama Connect helps teams reduce unacceptable risks

Discover how Jama Connect can empower Automotive and Semiconductor development teams to evaluate and ensure compliance.

Below is an abbreviated transcript of our webinar.

Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development

Steve Rush: Hi everyone. I’m happy to be here today to take you through the presentation. I wanted to start with a high level agenda and an introduction. We’ll be discussing Automotive compliance in general. To start, we’ll be looking at specific service offerings that you can use to help leverage, to evaluate your compliance against certain Automotive standards.

There are two forces often related that I like to think about when it comes to compliance that really impact the organization as a whole, from engineers to executives and everybody really in between. And those are process and quality. And I like to think about compliance as the intersection of those two often related ideas. Meeting the objectives of these standards may achieve both process and quality, but developing a compliant process and system, this will speed up development by instituting good process and reducing rework. It will help catch and identify defects early in the development process. However, there’s many evolving regulations and standards in this Automotive sector that make the idea of compliance all the more challenging to understand, let alone demonstrate. Perhaps you don’t even know where to start when it comes to achieving compliance in an Automotive system. It might feel like you are building a car while it’s driving.

At the same time tasked with implementing the process and tools to support the process and unsure which should come first. And we want to talk a little bit about this through the lens of compliance and make the case that Jama Connect is a tool well suited to get you up and running quickly, optimized against popular Automotive standards. To assist with this, we’ll discuss the diagnostic that Jama Software offers as a service that’ll help you navigate these important compliance questions. But I fully believe that by meeting the objectives of some of these critical Automotive standards we will discuss today that you’ll balance both process and quality and achieve compliance.

RELATED: Global Industry Leading Automotive Application Developer dSPACE Migrates from Legacy Requirements Management Platform to Jama Connect®

Sam Yerramalla: Today we are highlighting some offerings that will help guide Automotive customers or prospects like you with your compliance process. We feel these diagnostics can be very helpful whether you are a customer of Jama Software or a prospect. If you’re a Jama Software prospect who’s not yet purchased Jama Connect, these diagnostics makes the case that Jama Connect can help you meet the objectives of the Automotive standards. And namely, there are three standards offerings that we provide. One is the ASPICE Diagnostics, the Automotive Functional Safety Diagnostics, and the Cybersecurity Diagnostics. Now these diagnostics can help you navigate the classic process versus tool conundrum. That is if you’re trying to understand whether you should build the process first or buy the tool first, you’ll first see firsthand how Jama Connect will help shape the process. If you’re a Jama Software customer, you can use these diagnostics as a baseline. Oftentimes, we get busy with our day-to-day work and we may drift away from the larger big picture.

And these diagnostics are meant to guide you to bring light into areas that you need improvement or any optimization of your current Jama Connect process. You can also be paired with a Jama Software consultant or a solutions architect who will take you through the diagnostics start to finish. The time commitment for each of these diagnostics is about two to three hours. We feel that’s reasonable considering the benefits you may get out of this. We focus on the outcomes and the objectives and how this will truly help meet your compliance needs by optimizing your Jama Connect usage. If you’re a customer or getting up and running in Jama Connect, if you’re a prospect who’s looking for purchasing Jama, you can see these diagnostics offerings along with other offerings that we provide on the Jama Software Success Program page at Jamasoftware.com/success. Here you’ll see details on the compliance offerings that we just mentioned and a lot more other offerings including offerings on onboarding Jama Connect, improving your process and requirements, quality, traceability, et cetera.

RELATED: A Wise Investment: Requirements Management and Traceability Solutions During an Economic Downturn

Yerramalla: You can also request an offering if you have a service program with no assigned consultant and our operations team will pair you up with someone. So as far as the Automotive standards and alignments are concerned, the diagnostics offerings that we provide are aligned to the three standards, the Automotive Spice, ISO 26262 and ISO 21434. Only certain areas of those standards are in scope. For example, things like part seven of the ISO 26262 for production and operation and decommissioning are not covered here. But you will see some of these sections here are covered by the diagnostics. So depending on which diagnostics is right for you, the risks that are identified will align to the different areas that you see on the screen. Now, it may be that you want to align to more than one standard. We certainly put you through multiple diagnostics to identify your risks pertaining to each of these standard.

The model which we use is the same, but the recommendation we provide and tailored solution that the diagnostics provides will be custom based on each scenario. And if you don’t know where to get started or you don’t know which of these diagnostics that you need to start first. Some things are obvious, again, that if you’re looking for cybersecurity compliance and that is of the greatest concern for you, then Cybersecurity Diagnostics, the 21434 is right.

And if you’re looking for developing any functional safety products that are used in the Automotive, then the ISO 26262 diagnostics is the correct one to start with. And if you’re looking for any software process improvements or quality management, then ASPICE is the place to start. But sometimes you need both APSICE and functional safety, for example, in which case we suggest the ASPICE Diagnostics first. And the reason is that we rank in the process ASPICE about the functional safety is that if you have a high level of ASPICE maturity or on the other side, if there are several risks that are flagged from the ASPICE Diagnostics, then those will impact your Functional Safety Diagnostics already.

So you would’ve covered those parts of it that as a prerequisite for the functional safety. And then the spirit of ASPICE is really the quality management. And this is important in every engineering organization. So if you’re unsure where to start, then ASPIE Diagnostics is one place. And if you don’t need to prove compliance to the latter, it’s really good because honoring it, the lead benefits in your process.

To watch the entire webinar, visit:
Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development