Tag Archive for: Requirements & Requirements Management

DOORS

Jama Connect® vs. DOORS®: Filters, Search, and Analysis: A User Experience Roundtable Chat

Increasing industry challenges and complexities are pushing innovative organizations to consider modernizing the tool(s) they use for requirements management (RM). In this blog series, A User Experience Roundtable Chat About Jama Connect® vs. DOORS®, we’ll present several information-packed video blogs covering the challenges that teams face in their project management process.

In Episode 3 of our Roundtable Chat series, Richard Watson – Practice Director at Jama Software® – and Cary Bryczek – Director of Solutions Architecture, Jama Software® – walk us through filtering, searching, and analyzing content in Jama Connect® vs. DOORS®

To watch other episodes in this series, click HERE.

Watch the full video and find the video transcript below to learn more!

VIDEO TRANSCRIPT:

Richard Watson: Welcome to part three of our vlog series. I hope you’re enjoying the vlog so far. My name is Richard Watson and I’ll be representing DOORS today. In terms of experience, I’ve been using DOORS for just over 20 years and all of those was as the DOORS and DOORS Next product manager. I’m joined today by Cary.

Cary Bryczek: Hi everybody. I’m Cary. I haven’t had the pleasure of using DOORS for as many years as Richard. I’ve been blessed by not having to use it, but I have used Jama for a very long time and I’m the Director of Solutions Architecture here at Jama, and I’ve been in the requirements world for more than 25 years.

Richard Watson: Thank you. So in this vlog we’re going to be talking about requirements analysis, that’s filtering, searching, dashboards, etc.

Analysis is probably one of the most important reasons that we actually pick a requirements tool in the first place. The risk of life or the risk of lots of money gets organizations imposing compliance needs or their industry will give them regulations that they simply have to meet. And document-based systems just don’t give the relevant granularity to enable things like live traceability. So we need a tool.

Over time, the way we’ve engineered complex systems has changed and we find a much wider community of stakeholders are interested in direct access to the requirements. They want to actually go into the tool. And so usability of that tool becomes key. We also continue to get a wide dynamic set of users and new users, certainly younger users expect the tool to almost be like their social media apps that they’re using.

Cary Bryczek: Yeah, right but aren’t developing with the social media tools that the younger folks are used to. We’re doing real engineering.

Richard Watson: So how to persuade them to use an engineering tool?
Today’s tool engineers are being overwhelmed by data. Data can have, of course, huge value, but if you can’t find the data, it can sometimes even hinder your process, let alone give you any value.

Cary Bryczek: To do that analysis, we need to know how the information is stored, maybe even over multiple systems and how it’s all related to each other. We need to have different views of all of that trace data to ensure that really everything is being done as expected.

RELATED: Jama Connect® Solution for IBM® DOORS®

FILTERS AND SEARCH

Richard Watson: So, okay, let’s start digging into the details. If we start with filters and search. Looking at DOORS, DOORS obviously has a world that’s wrapped around individual modules, and so trying to filter and search information across modules is next to impossible.

Initially, when we started out using DOORS years ago, that was okay. Today it’s not. Today we’re finding organizations have got thousands of DOORS modules and millions of requirements in those are total modules. It’s really difficult to find the data that you need. When you’re in a module, of course, DOORS has got quite sophisticated, complex filter definitions, but even they’re frustrating because if you want to modify them for some reason, perhaps you need to change them or maybe they’re even wrong, you have to start from scratch and normally, you need help to do that.

If we jump the fence DOORS Next, DOORS Next is DOORS next generation. It should be the next generation of DOORS, but it’s hampered by its history. DOORS Next actually was developed on top of an original tool requirements composer. And in order to introduce the DOORS, facilities, modules were added. And as a secondary fun function, modules actually confuse the situation. For example, when you add a requirement to a DOORS Next module, it also gets added to what’s called a base folder. And so when you’re searching for information, you need to know whether you’re looking for the requirement in a module or whether inadvertently you find that requirement in the folder. Sometimes you can even count these requirements twice because they’re in two separate places.

Cary Bryczek: Richard, that sounds complicated even listening to you describe it. Jama is a modern tool and we took a completely new approach with a web-based UI that’s designed for anybody to get up and running. And filters and searches is one of the prime areas that make it really super simple and easy to use for analysis.

Let me just show you what I mean. When we created Jama, we wanted it to be easy to use right away, and finding information should be just intuitive as possible. You don’t have to write any kind of DXL. I can see filters that I already have. I can see just things that I’ve bookmarked creating and searching. Again, I don’t have to write any DXL. It should just show me the particular type of requirements. I can even find things across. What are the ones that don’t have any downstream relationships.

Richard Watson: Yeah. This is so much different to DOORS, and also it’s an improvement over DOORS Next, Cary, because you can do filters on the information at the other side of the relationships and that’s quite difficult to do in DOORS Next and you just can’t do that in DOORS at all.

Cary Bryczek: Yeah. Filters are built into almost any view that you’re on. So if I’m right in a view that I’m looking at requirements, I’m able to filter it right there, filtered by keyword, filtered by the types of things that are in the view, even through traceability.

Richard Watson: Yeah. That’s really interesting, Cary. I particularly liked the way you were doing filters over relationships. I mean you consider it trying to do a filter in DOORS Next, which is impossible saying show me requirements related to defects that have been raised against failed test cases. You just can’t do that type of filtering inside of DOORS Next. So it’s pretty cool in Jama.

RELATED: Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense

DASHBOARDS

Richard Watson: Also, you’re showing the dashboard functionality. Dashboards in DOORS just don’t exist. So it’s got a welcome screen so you can sometimes see information on that welcome screen, but that was introduced so late in the process or the release schedule that not many organizations use it.
DOORS Next, of course, has dashboards, but again that’s hampered by history. DOORS Next dashboards are very much focused on requirements in folders. So for our DOORS user moving into DOORS Next, you’ll find that the maturity of dashboards around module information is pretty limited.

Cary Bryczek: With Jama, our dashboard technology is built right into the tool. You don’t need any extra add-on servers to make it work. And it’s something that is used as a launchpad for different stakeholders to get to the information. Let me show you what I mean.

We have dashboards that are built right in. The reporting engine is native inside of Jama itself, and then so you can take those filters that we were creating earlier and turn them into widgets, into pie charts, into bar charts, then you can download the information. You can download a picture of the things. You can see which requirements don’t have tests, what are the suspect ones, which are the recently viewed things, what’s the progress, which are the things that I’ve touched in the past few days. So if I need to pick up where I left off, launch that directly from a dashboard review.

RELATED: G2 Recognizes Jama Connect as the Only Leader in Requirements Management

ANALYSIS

Richard Watson: Yeah, that’s cool. I like the traceability map there as well. That’s really good. So let’s move on and talk about analysis of requirements. Analysis of requirements is where the fund is and we can start with DOORS.

DOORS has some analysis for capabilities, but mostly organizations are expected to develop DXL solutions. DXL it’s a cool thing to fill in gaps. I remember going around many of the software conferences and people will actually proudly come to me and say, “Hey, Richard. Our organization’s got hundreds of thousands of lines of DXL scripts,” sometimes over a million lines of DXL scripts.

Think about what we’re saying. A million lines of customization code where the organization’s core business is not developing requirements tools. That DXL hampers the performance of DOORS. Sometimes you lose sight of what’s making DOORS go slowly. Is it DOORS itself or is it a customization? And also, as time moved on, the number of people that have got skills in developing DXL is diminishing greatly. And so if you try to, you are exposing your organization to risk because you can’t maintain or extend your current environment.

Jumping the fence to DOORS Next, there’s a different problem entirely. DOORS Next, of course, doesn’t support front end customizations. It doesn’t support DXL. When you look at DOORS Next, actually you start to look at traceability. We want a system that can see an overall view of live traceability between data so that you can analyze that information. And the only way you can do that in DOORS Next is either with an additional tool, so Jazz reporting system, or you start looking at OSLC techniques. OSLC is okay if you’re looking at your Jazz-based products only. It’s got some very big constraints if you’re starting to get tools from different vendors. So you get tied into a single vendor solution simply because of the lack of maturity of OSLC implementations.

Cary Bryczek: Gosh, Richard. Again, that sounds really complicated. And one of the great things that Jama software did was build all of that workflow capability, all of the bits and pieces that you’d have to do with DXL into the software. So people just come in to Jama Connect and just start using it. And the live traceability aspect is probably my favorite aspect about the tool and it’s super powerful. Let me show you what I mean. One of the things that’s great is that live traceability enables pretty much anyone to find anything at the current moment across boundaries. And so, one of the ways that we start live traceability is through that relationship rule diagram. I can see the schema for what’s traced, and this information might be coming in live from other tools in the ecosystem.

We give you an easy way to organize. So if I’m starting to analyze a system just following this explore tree, and seeing how the information is organized by system and subsystem for this aircraft. Now once inside, just navigating to find that information is super simple. I even have live traceability here in the tools itself, so in the requirements, so I can see this particular function requirement, it traces to a system requirement.

Traceability is in almost every view that we look at. So if I’m in this one detail view of a requirement, I know it’s got upstream and downstream traces. If I’m in the live tracing view, my live tracing view, this is a multi-level view of requirements. So I can see if I’m following these requirements on down to the validation level or the system level. I can walk that traceability all the way down, multiple levels of requirements to look at test runs, to look at any defects along the way. It’s really powerful. And then I can start and filter right where I need to be. So if I want to have a filtered start from a filter view, which are the ones that are causing suspect?

Now, this shortens the amount of information that I have on the screen. It really makes the analysis much faster to do than having to work with DXL scripts or exporting stuff to spreadsheets and looking at the information.

Richard Watson: Thanks very much, Cary. That insight to Jama Connect is just reminding me of my last 18 months in Jama. I’ve really enjoyed picking up the Jama Connect product, really excited by it.
That brings us to the end of this particular vlog. I hope you all enjoyed it, and please feel free to take some time to look at some of the other vlogs in this series. Thanks very much, Cary.

Cary Bryczek: Thanks, Richard.

Thank you for watching our Episode 3, Jama Connect vs. DOORS: Filters, Search, and Analysis. To watch other episodes in this series, click HERE.

To learn more about available features in Jama Connect, visit: Empower Your Team and Improve Your Requirements Management Process

We hope you’ll join us for future Jama Connect Jama Connect vs. DOORS topics, including: Review and Collaboration; Document Generation; Migration & Data Mapping; Industry Templates; Reuse and Variant Management; Requirements-Driven Testing; Total Cost of Ownership; and Why Did We Move to Jama Connect? A Customer’s Story.


Jama Connect Advisor

In this blog, we recap our press release covering the new performance and scale benchmarks set with the release of Jama Connect Advisor™ – The Industry’s First Native, Natural Language Processing (NLP) Advisor to Improve Requirement Quality.

Jama Software® Releases Jama Connect Advisor™ – The Industry’s First Native, Natural Language Processing (NLP) Advisor to Improve Requirement Quality

Jama Software®, the leading requirements management and traceability solution provider, has announced the launch of the Jama Connect Advisor™ — an intelligent, natural language advisor that improves the quality of requirements based on industry-recommended best practices by INCOSE (International Council on Systems Engineering) rules and EARS (Easy Approach to Requirements Syntax) notation for successful product development and market delivery.

Maintaining requirements quality is critical for product development as studies have shown that 70 to 85 percent of rework is due to faulty requirements. Efficient, precise, and accurately written requirements are the single source of truth that aligns development effort across engineering disciplines reducing rework, lengthy integration meetings, and costly late-stage surprises.

“Requirement quality is critical to our success, but it is hard to train and enforce. Jama Connect Advisor gives us the ability to train new engineers and ensure consistent requirement quality across projects – a real game changer for us,” said Sheila King, Senior Project Engineer, Rockwell Automation.

Companies not only benefit from reduced rework, but also the automation of training for new engineers to learn requirements authoring best practices. Jama Connect Advisor provides self-paced training as requirements are being authored and reviewed to help new engineers ramp up quickly without placing time demands on more experienced engineers.

“Needs, requirements, verification, and validation are common threads that tie all systems lifecycle activities and artifacts together. Because of this, the quality of the needs and requirements is critical to project success. Tools such as Jama Connect Advisor — that aid those defining well-formed needs and requirements and have the characteristics defined in the INCOSE Guide to Writing Requirements — are invaluable,“ said Lou Wheatcraft, Senior Consultant, Managing Member, Wheatland Consulting, LLC, and Co-Chair INCOSE Requirements Working Group.

Jama Connect Advisor helps engineers and product developers:

  • Leverage engineering-based natural language processing guidance while editing within Jama Connect®
  • Author intricate product requirements quickly, easily, and with precision
  • Develop and improve authoring skills through guidance based on industry-recommended practice by INCOSE Rules and EARS Notation

“Jama Software is committed to helping our clients improve the performance of the engineering process. Fundamental to this improvement is ensuring the quality of requirements through intelligent analysis and automated training for new engineers,” said Marc Osofsky, Chief Executive Officer, Jama Software.

Key Benefits of Jama Connect Advisor:

  • Reduce costly rework
  • Automate the training of engineers on requirements authoring best practices
  • Eliminate late-stage errors due to faulty requirements
  • Reduce tedious and morale-draining integration meetings
  • Increase engineering productivity through quality automation

With correct, precise, and efficient requirements, companies can accelerate product development to remain competitive in this new era of innovation.

For more information on Jama Connect Advisor:
DOWNLOAD THE DATASHEET OR CLICK HERE TO TRY OUT JAMA CONNECT ADVISOR FOR FREE!

Read the entire press release here! Jama Software® Releases Jama Connect Advisor™


Jama Connect vs DOORS

A User Experience Roundtable Chat About Jama Connect® vs. DOORS®: Adoptability for All Stakeholders

Increasing industry challenges and complexities are pushing innovative organizations to consider modernizing the tool(s) they use for requirements management (RM). In this blog series, A User Experience Roundtable Chat About Jama Connect® vs. DOORS®, we’ll present several information-packed video blogs covering the challenges that teams face in their project management process.

In Episode 2 of our Roundtable Chat series, Cary Bryczek – Director of Solutions Architecture, Jama Software® and Susan Manupelli – Senior Solutions Architect,  Jama Software® – walk us through the importance of adaptability, and ease of use, for all stakeholders in a requirements management tool.

To watch Episode 1 of this series, click HERE.

Watch this short video below to learn more and find the full video transcript below!

VIDEO TRANSCRIPT:

Cary Bryczek: Hi everybody. Welcome to part two of our vlog series. I hope you’re enjoying the series so far. My name is Cary Bryczek, and I’ll be representing Jama software today. In terms of experience, I’ve been using Jama for nine years, but have used DOORS and numerous other requirements tools for the past 20 years. I’m joined today by Susan.

Susan Manupelli: Hi there. My name is Susan Manupelli. I’m a solutions architect here at Jama Software. Prior to joining Jama, I was a test architect working on the engineering lifecycle management suite of products, particularly on Rational DOORS Next Generation and the Global Configuration Manager. So I’m happy to be here with you today to talk requirements management adoptability

Cary Bryczek: Thank you Susan. In this vlog, we’re going to be talking about the adoptability for all stakeholders. Adoptability, it might be the most important aspect for a requirements tool and sometimes it’s the most overlooked. Adoptability isn’t just about being able to get users to actually use the software, but it’s about how well it fits into the IT ecosystem. How hard or easy it is to maintain, or even whether or not the organization recognizes its benefits.

UI, Ease of Use, and Adoptability

Susan Manupelli: Right. Let’s talk… One of the first challenges in the adoption of DOORS Classic is that many dev teams are distributed globally. DOORS is a legacy client server application, which doesn’t scale well over the WAM, so DWA, DOORS Web Access, was released as the answer to that problem, but it lacks significant functionality only available in the desktop client.

Another challenge with DOORS Classic is that the UI look and feel is very dated. Modern engineering teams are energized by utilizing the very latest technologies for developing state-of-the-art products for the future, and then they’re asked to use a requirements tool that was designed some 30 years ago. So that just doesn’t fly very well.

Let’s talk a little bit about DOORS Next Generation. It was marketed as a new modern alternative to DOORS Classic. Unfortunately, it’s very hard to use. There are too many different options for use and a lack of direction on best practices. So we’ll go through some of these challenges in the vlog.

The first place where users struggle to adopt DOORS Next Generation is a very basic question; whether to use modules or not. DNG originally only allowed you to organize requirements in a tree view hierarchy of folders. And later, to accommodate users that were more familiar with DOORS Classic, modules were added to DNG. Modules provide a document-like view for requirements, but these same artifacts outside of the module view show up in alpha numeric order in the true view, it makes organization of artifacts outside of the module very confusing.

RELATED: Jama Connect® Solution for IBM® DOORS®

Cary Bryczek: Wow. Yeah, that does sound complicated to comprehend. Jama was developed as a web-based solution from scratch. We wanted to fulfill the lowest common denominator stakeholder so anybody could come in and use our software. Our UI is modern and intuitive. Let me show you what I mean.

This is what I mean about our UI. It’s very streamlined. There’s hardly any button clicks or menus to learn how to use. There’s four main menus. And then the rest of them are kind of like right click kinds of options. We have the dashboard built right in. Our views are super simple. The explorer tree matches exactly what you see in our list view. And our views are very simple to navigate. So if this is the list view, and I wanted to see a document or a reading kind of view, I can just toggle the buttons to show those different types of views.

Teaching someone how to use this is really super simple, and it doesn’t take that much time at all. In fact, analysts have even recognized Jama Software as being the easiest user tool in the marketplace. You can go out there and see something like from G2, which queries users without us even knowing about it to get their direct feedback on the tools.

Link Relationship Rules and Traceability

Susan Manupelli: Well thanks, Cary. That was great. Another area that’s confusing in DNG has to do with linking. Linking behavior is different between module artifacts and non-module artifacts. A lack of understanding leads to incorrect or incomplete traceability analysis. In DNG, if you link to artifacts that are outside of a module, the link is placed on the core artifact. If you link to artifacts within a module, the link only appears in that particular module. If you then print a traceability report, you’ll only see links made in the module context. So links to core artifacts won’t be displayed. So as a user, that behavior is very confusing.

Another gate to adoptability has to do with enforcing link relationships. Enforcing relationship rules in DNG it’s just hard to do. Either all links are allowed, which means that users can kind of willy-nilly apply link rules that don’t make sense really for relationship, or allowed link rules are specified in a list form for a given component, and then they must be recreated across all components in the project. There’s also no visual representation of link rules in DNG, and there’s no notion of enforcement of required link rules, so compliance is hard to maintain.

Cary Bryczek: Gosh, just listening to that sounds really confusing to me, and I’ve even used DOORS. In Jama, linking is just straightforward. If an item is linked to another item, that link relationship will be visible wherever you are in the UI. We also have the capability to see what our relationship schema looks like and enforce a consistent way to apply traceability. Let me show you what I mean.

There’s a couple of different ways to look at the traceability. I can see that traceability right away. So I know that this standard aircraft platform requirement is traced to another object downstream. I can see the traceability numbers, so this one in this list view. I can see that this one requirement has five different traceability things. I can see it also in the trace view. We’ll tee up a live real-time version of what’s currently traceable out there. It’s very easy to see where there’s gaps in traceability because there’s just no information there.

We have our traceability rule set. Think of this picture as being the schema for what types of objects are allowed to be traced to one another. So I might have four levels of requirements traceability. I might have test cases in there. And so this set of rules would enforce the users to create consistent traces. And then I can follow those rules down in the live trace view as well. So if I’m following this aircraft level requirement, I can see the system requirements, and any kind of lower level objects, whether those are high level software requirements. Here I see some verification tests and agency test runs. Traceability is really made to be super intuitive, real-time, live, to allow anybody to understand and analyze the current situation.

RELATED: G2 Recognizes Jama Connect as the Only Leader in Requirements Management

Administration and Maintenance

Susan Manupelli: Another common issue is that DOORS Next is hard to administer and maintain. Upgrades are often a challenge. As major architectural changes have occurred in recent releases of the DNG, the time and effort and ultimately the cost to upgrade has been daunting.

Another area of maintenance in DNG has to do with the type system. The type system, that’s the part of DNG that keeps track of your artifact types, your attributes and your values and their relationships. And that needs to be consistent from project to project for cross component and cross project reporting. And there’s no global way to keep these items in sync from project to project or component to component.

Cary Bryczek: Cool. That’s really different than the experience here at Jama. Our host of solutions get updates just about every 60 days. Middleware and security updates are handled as necessary. And sometimes the middlewares might take six months to a year or so. Very stable releases and changes to the ecosystem. We have self-hosted solutions and even customers that have air gap, we can satisfy those sort of ecosystem environments. Very easy to set up and deploy.

Now, it was interesting that you talked about, Susan, though the type rules. In Jama, we’re a little bit different for item types and attributes. We define those globally. Here’s an example.

Our type rules are defined globally, like I said. Here’s an example of schema for the types that are relevant to this particular achiever one project. When we define them globally, it’s all point and click kinds of experience of dealing with that. These attributes are now consistent from project to project to project. And that way you can have really easy reuse scenarios. If you’re doing complex scenarios like product line engineering or if you have complex libraries of data that you use from one project to the next, having that consistent type definition really makes it easier for you to do analysis, leverage reuse, have shorter project startup times.

RELATED: Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense

Running and Exporting Reports

Susan Manupelli: Yeah, sure. I can definitely see that. One other area that I wanted to talk about has to do with reporting. For all the effort that’s put into DNG to maintain the projects, to build up the requirement specs, the reporting needed to meet certifications is hard or sometimes impossible to create. Mistakes or inconsistencies in the type system that we just talked about, those often manifest as issues once you try to do some traceability reporting. Keeping data consistent between DNG in the reporting data stores has proven to be a challenge, so we’re talking about the data warehouse and LQE. And basically robust reporting out of DNG requires the use of additional IBM tooling, either Jazz Reporting Service, or RPE, the Rational Publishing Engine, and those products are outside of DNG.

Cary Bryczek: That sounds complicated. Again, one of the great things that we have at Jama is our reporting engine is built right into Jama itself. And Jama is a single application, so there’s no deploying 11 different servers of applications that are sort of cobbled together through an integration under the covers. Jama is just a single application. And exporting is super easy. Let me show you what I mean.

We have lots of built in reports. Lots of different kinds of reports that you can add in. We have the capability to export directly to Excel, Word, right there. All a user has to do is configure the view that they’re looking at, whether that’s the reading view or the list view that’s customized to match what they need to have. And then they can have the built in export templates that are just creatable via Microsoft Word templates, so there’s no custom coding in most cases that a user has to do to run these kinds of reports. Doesn’t that sound much easier, Susan?

Susan Manupelli: It sure does.

Cary Bryczek: That brings us to the end of this particular vlog. I hope you all have enjoyed it. Please, I hope you also take some time out to look at some of the other vlogs in this series. Thank you so much, Susan, for your perspective on DOORS and DNG as well.

Susan Manupelli: Thank you Cary. Happy to be here.

Thank you for watching our Episode 2, Jama Connect vs. DOORS: Adoptability for All Stakeholders. To watch Episode 1 of this video series, click HERE.

To learn more about available features in Jama Connect, visit: Empower Your Team and Improve Your Requirements Management Process

We hope you’ll join us for future Jama Connect Jama Connect vs. DOORS topics, including: Adoptability for All Stakeholders; Filters, Search and Analysis; Review and Collaboration; Document Generation; Migration & Data Mapping; Industry Templates; Reuse and Variant Management; Requirements-Driven Testing; Total Cost of Ownership; and Why Did We Move to Jama Connect? A Customer’s Story.


Systems Development

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Lifecycle Insights – Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™  – which was originally published on August 17, 2022, by John McMillan.

Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™

How does Jama Software®’s approach to managing the vast array of complex engineering requirements provide organizations a competitive advantage? Their approach is a software solution developed specifically to provide unified requirements management and traceability across organization development processes whether that be the traditional V-model, Waterfall, Agile, or otherwise. Jama Connect requirements management software with Live Traceability was designed to help development and engineering organizations improve quality, reduce rework, ensure compliance, and get high-quality complex products, systems, and software to market faster and on budget.

Historically in product development, each engineering discipline utilizes tools that are specifically suited to maximize their ability to be innovative and productive in their own design space. Communication between other disciplines and the broader organization however has historically been siloed or fragmented and often managed through “throw-over-the-wall” manual approaches. Those approaches are error-prone and often result in discovering late-stage issues downstream that result in design rework, delay product delivery, and create cost overruns that impact the organizations’ bottom line.

The Cost of Discovering Late-Stage Issues

When late-stage issues are discovered during integration testing, systems testing, and during final acceptance testing they are expensive to fix. Jama Connect platform was developed to enable organizations to detect and correct requirement and testing issues and solve disjointed discipline problems. This is provided through a requirements management platform designed specifically to help engineering organizations align people, processes, and tools in one concise application early on and throughout product development- when the cost of change is lowest.

Jama Connect was designed to provide unique real-time visibility and actionable insights for the end-to-end product, systems, and software development processes. Within the application, users develop relationship models between each discipline’s tools by way of data elements. These data elements are connected with direct tool integrations with Live Traceability. Once the flow of each element’s connections is defined and reflected throughout the system – should a data element be modified, the connected element stakeholders are alerted, and each discipline can review and address any changes accordingly. The application’s unique open architecture allows integrations with a range of premium solutions across the full ALM-PLM tool ecosystem.

Related: Requirements Traceability Benchmark

What about Integration and Customization?

Jama Connects list of supported tools and plug-in integrations for Live Traceability is already quite extensive and is growing.

  • For Design and Simulation model-based requirements management Connect seamlessly integrates with MBSE and SysML tools including Ansys, MathWorks, Enterprise Architecture, and Catia’s No Magic.
  • For Task Management, Live Traceability is directly supported for Jira, Bugzilla, Azure DevOps, and TFS without any changes required by software developers’ preferred tools, methodology, or field values.
  • For PLM and PLE link requirements to hardware specifications and product line engineering for traceability and impact analysis are seamlessly supported for Teamcenter, Windchill, Aras, Pure-Systems, and BigLever.
  • For Test Automation, live trace requirements and test cases to automated testing results are supported from tools including Tricentis, Ansys, LDRA, TestRail, ZEPHYR, Vector, Jenkins, Bugzilla, and Parasoft.
  • For Risk Management, traceability is supported from Ansys FMEA/DFMEA calculations as well as Microsoft Excel including functions and spreadsheets, is also supported without any changes required to Risk team’s tooling or approaches.
  • For DevOps, Live Traceability is extended down to source code with applications including GitLab, GitHub, and Azure DevOps with no changes required to software developers’ tools or methodologies.

Though Jama Connect provides users with the ability to develop custom model system frameworks, it also includes the frameworks for plans, templates, and checklists that are specifically aligned to industry standards for medical devices, automotive, semiconductor, aerospace, defense/government, software development, and industrial manufacturing. In addition, an extensive list of industry standards and regulations are supported including ISO, IEC, FDA, EU, SEBoK, ARP, DO, and more. These industry-specific standards help organizations ensure end-to-end compliance, mitigate risk, and overall process improvement guidance.

Addressing risk management with system analysis that is tailored to each product’s industry standards and regulations, “left-shifts” risk management throughout the product’s development flow and in turn serves as an integral part of the product lifecycle process. Organizations can standardize and integrate their own risk analysis, evaluation, and risk management processes within Jama Connect’s platform to create a single source of truth for everything risk related.

In addition to risk management, Jama Connect provides critical verification and validation requirements for complex systems via test management. The tool supports customized reporting for proof of regulatory compliance and performs manual user-acceptance testing to ensure products are designed with end-users in mind. The tool generates links to disparate processes, sources, and people that increase visibility and simplifies the user’s path to compliance with traceability of tests back to its requirement. It also traces failed tests to new and existing defects for quick resolution, enabling users to reuse validated requirements saving time when testing consistent features across products.

Related: The Comprehensive Guide to Successfully Adopting Model-Based Systems Engineering (MBSE)

MBSE Platform, Decision Making, and Traceability

MBSE (Model Based System Engineering) is another key area that Jama Connect provides a streamlined and collaborative data-driven approach to in the product development cycle. Jama Connect’s Traceable MBSE™ platform combines requirements, architectures, behaviors, verification, and validation into a single model of the system by applying structure and rules for data and a consistent interface language between the parts of the system. The MBSE platform is designed to help organizations formalize the development, integration, and use of models to inform enterprise and program decision-making. It also allows non-technical stakeholders to visualize a model of the system of interest and interact with its data in familiar views like documents and spreadsheets.

A leading problem that product engineering organizations face is complying with traceability spanning siloed teams and tools (e.g., design, hardware, software, test, risk, quality) creating an increased risk of negative outcomes such as extensive rework, delays, & cost overruns. Requirements traceability across the entire systems development lifecycle is a core tenant of the systems engineering discipline and underpins industry standards to ensure higher quality, faster cycle times, and less costly rework.

RELATED


IVDR

This is part 2 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which was created to replace the previous In Vitro Diagnostic Directive (IVDD).

Part 1 of this blog series is available HERE. To read the whitepaper in its entirety, download it HERE.

The New EU In Vitro Diagnostic Regulation (IVDR): What’s Changing and What You Need to Know

The IVDR Overview

With more than 150 pages of regulations, there were many changes to strengthen and grow the path to IVDs marketed and distributed in the EU. The IVDR provides a more comprehensive approach to regulating devices as it encompasses the entire product lifecycle: from initial concept to design and manufacturing, to continual on-market support along maintaining good documentation practices. For the purpose of this paper,
only a few selected topics will be covered in detail with some additional insights from an industry perspective.

Related: Download the Full IVDR Regulation Here

High Level Overview of the IVDR and Key Facts:

Who is impacted?

Medical companies that develop IVD’s marketed to the European Union, and its population. This includes non-EU-based companies that have products in the EU region.

What is impacted?

In-Vitro Diagnostics (IVDs) products and accessories that are used to perform tests on various sample types to help diagnose a condition, detect infections, or monitor drug responses.

When is it happening?

Date of Application: May 26, 2022, where only IVDR applications will be accepted by NB. A two-year window period afterwards to allow companies to transition their IVDD to IVDR certification. By May 2025, all IVDD certificates will be voided, with IVDR covering all placed IVDs in market.

What countries are impacted?

European Union and the United Kingdom specifically, but companies from around the world who have products in the UK or EU are also required to conform.

Why are things changing?

To improve the safety and quality of IVDs in the EU market.

Discuss on Key Topics

Changes to Classifications

A key significant change of the new regulation is how IVD’s are classified. Similar to the previous directive, a risk-based approach (with respects to public and patient) is used to classify IVDs under the new IVDR framework. There are four main classes as listed in the table below, established by seven classifications rules defined in Annex VIII of IVDR.

While there may be nuances to the rules set, these four categories broadly cover the majority of the IVD spectrum. This new classification schema only allows Class A devices to be self-certified by manufacturers, whereas Class B, C, and D require more assessment and certification by notified bodies.

As in similar regulatory pathways, device classification is significant in determining the overall requirements, as the higher the IVD risks, the more onerous the regulatory requirements, and the higher the involvement with an external Notified Body. For example, a new HIV Test would be categorized as Class D, which would require the highest number of internal activities during design, development, on-market support, and associated documentation. This would also require the highest amount of interaction, assessment, and certification from the Notified Body. Furthermore, specific regulations such Post-Market Surveillance, Quality Management System elements, and annual updates to reports are required for higher risk class (C and D) devices.

Based on general research from industry subject matter experts, it was estimated that only 20% required Notified Body certification under the previous IVDD, while 80% did not require certification. With the new classification schema and requirements under IVDR, that ratio has flipped where it is expected that the majority of IVD’s (80%) will now need some Notified Body involvement. This new shift (in engaging Notified Bodies and the new requirement) is significant in many ways as it not only impacts the manufacturers, but also the Notified Bodies as demand for their engagement has risen exponentially. There are some concerns about the current Notified Body capacity, so it is encouraged to start engaging with a Notified Body proactively, as the backlog to engage could be longer than anticipated.

IVDR Chart

Related: The Impact of ISO 26262 on Automotive Development

No Grandfathering Clauses

For certified IVD’s that are currently on-market classified under the IVDD guidance, reclassification to the IVDR categories and recertification to meet the IVDR is required for continual sale and distribution to EU market. Under the IVDR, there are no grandfathering clauses to allow the IVDD devices to remain on market after May 2025. Considering there are many IVD’s in use, the EU established a five-year timeline to allow manufacturers to transition to IVDR. See the timeline below for more details.

IVDR TransitionalSince IVDR’s announcement in 2017, many companies and SME’s (including this author) started to update
their internal procedures, adjust development and documentation activities, and hire additional resources
in response to the impending changes. In addition, remediations to current devices’ Design History Files
(DHFs) to align with regulations were also underway. These include adding additional testing for new
requirements such as performance studies, clinical evaluations, etc. These activities may be significant,
and a major resource pull from other ongoing projects. Therefore, it’s critical to acknowledge that the new
IVDR regulations impact not only future but current IVDs on the market as well.

Related: Medical Device: Reduce Project Risk in the Product Development Process

One Person Responsible for Regulatory Compliance

Under Article 15, a new IVDR requirement is that manufacturers are required to have a regulatory compliance expert in their organization to be responsible for the compliance of the in-vitro diagnostics regulations. This person must be a qualified regulatory expert with previous demonstrated qualification such as 1) formal certification from approved regulatory body and/or 2) minimum of four years of industry experience as a regulatory affairs professional in the IVD field. This role (new for some organizations) provides general regulatory affairs guidance, interpretation of regulations to internal teams, and helps facilitate discussions with Notified Bodies, regulatory agencies, and EU Competent Authorities.

Establishing Risk Management

While not a new requirement to IVD practices, Annex I Chapter I of the IVDR has multiple languages referring to and establishing risk management practices. This further substantiates the EU focus on a riskbased approach when developing devices and encourages many best practices that Jama Software® has seen many of our IVD customers follow.

This new language includes the following requirements:

  • To establish, implement, document, and maintain a risk management system.
  • To enforce continuous and iterative risk management process with regular updates to the risk files throughout the device lifecycle, especially after the product has been launched to market.
  • To reduce risks as far as possible without adversely affecting the benefit-risk ratio and inclusion of this analysis in technical files submission. This includes risks related to use errors of the device.
  • To consider design accommodations to assure that characteristics of safety and performance are maintained during the transport and storage of the product, and for the expected lifetime of the product.
  • To minimize all known and foreseeable risks and be acceptable when weighed against the potential benefits.

This updated language continues the industry practice of risk management that is further established in ISO 14971 “Medical Devices – Application of Risk management to Medical Devices” and TR 24971 “Medical Devices – Guidance on the application of ISO 14971.” Based on the reasons why the IVDR came into fruition (PIP accidents), it can be surmised that an organization’s risk management process will be under significant scrutiny by the Notified Body. Therefore, Risk Management Procedures have been a focal point of update for organizations to strengthen risk practices and ensure compliance. Remediation of risk files may also be warranted for devices currently on the market, or soon to be on the market in the EU.

Based on this author’s experience, this risk activity alone requires significant time and resources to accomplish. Considering some risk files could have significate number of documents (plans, evaluations, reports) with details that require comprehensive review from many stakeholders, this is an effort that needs formal organization support to successfully comply with the IVDR and its compliance timeline. Therefore, it is recommended to prioritize
appropriately and revisit the Risk Management section, and other impacted areas of the IVDR as soon as possible.

Related: Whitepaper: Application of Risk Analysis Techniques in Jama Connect® to Satisfy ISO 14971

General IVDR Guidance for Medical Device Companies

Based on discussions with various IVD customers, general research, and internal experience, we recommend the following guidance:

  • Determine the new IVDR classification for each of your devices on market, or plan to be launched in the EU, and their associated requirements. Consult with Regulatory affairs to proactively affirm
    classification with a notified body.
  • Review and remediate procedures and documents to include new IVDR regulation languages and requirements. Based on your organization’s level of compliance, this could be a significant activity so
    may need management support.
  • Identify the accredited regulatory affairs expert in your organization that will be responsible to drive the activities to comply with the IVDR regulations. This may include updating general regulatory
    procedures, product development processes, and for existing technical documentation.
  • Review and update risk management procedures to include new requirements such as regular updates of the risk files, incorporate use-risk scenarios, and ensuring the benefit-risk comply with
    new language.

As with many types of changes in regulations, these have substantial impact on how organizations and their teams operate in the design, development, and manufacturing documentation of IVDs. It is encouraged to proactively review these new regulations as it may require significant time and resource to adapt to continue developing IVD’s for the European market.

DISCLAIMER
Jama Software is not an accredited regulatory subject matter expert, so these are general guidance and insights from working with many IVD customers, general research, and some internal experience. It is suggested to work with a certified Regulatory Affairs consultant for formal recommendations for your organization.

References:
1. https://www.bsigroup.com/meddev/LocalFiles/en-IN/Technologies/BSI-md-ivd-diagnostic-directive-guide-brochure-UK-EN.pdf
2. https://ec.europa.eu/growth/single-market/ce-marking_en

Accelerate Innovation in Medical Device Development While Adhering to Industry Regulations

With the new IVDR, it is expected that manufacturers will need to shift to a more regimented process of developing, manufacturing, and managing IVD’s. Similar to other regulatory pathways, good requirements management is the best practice in ensuring compliance with regulations, reducing risk, and launching safe and effective products.

Jama Connect® for Medical Device Development helps medical device teams reduce the effort required to achieve regulatory compliance throughout the development process. With this solution, medical device teams can manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market. Jama Connect creates a digital thread for systems engineering and
ensures Live Traceability™ and alignment across the product development lifecycle to seamlessly connect development solutions and facilitate product success.

Related: Learn What’s Included in Jama Connect’s Medical Device Development Solution

ABOUT THE AUTHOR, VINCENT BALGOS
Vincent Balgos currently leads the Medical Solution at Jama Software. Prior to joining Jama Software, he worked in the medical device / IVD industry for over 17 years with roles in systems engineering, product development and project management. Vincent has successful history in launching new products to the global regulated market, and is experienced in product development, risk management, quality systems, and medical device regulations.

Part 1 of this blog series is available HERE. To read the whitepaper in its entirety, download it HERE.


In Vitro Diagnostic Regulation (IVDR)

This is part 1 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which was created to replace the previous In Vitro Diagnostic Directive (IVDD).

We will share the link to part 2 when it publishes. In the meantime, you can download the eBook HERE.

The New EU In Vitro Diagnostic Regulation (IVDR): What’s Changing and What You Need to Know

Learn more about how IVDR differs from IVDD, key takeaways from the new regulation, and guidance for how to adapt.

Disclaimer: The IVDR regulation is broad and requires focused review and interpretation by each organization — so by no means is this paper intended to be all-exclusive, as it will only discuss select topics.

Jama Software® is not an accredited regulatory body, so these are general discussions and insights from our experience working with many IVD customers, general research, and some internal subject matter expertise. It is suggested to work with a certified Regulatory Affairs consultant (a new IVDR regulation) to obtain formal recommendations for your organization.

If you’re looking for guidance on who to work with when it comes to regulatory compliance, TÜV SÜD has provided certification and testing services for manufacturers and suppliers of medical devices and in vitro diagnostics for over 30 years.

They combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing you with a one-stop solution. In fact, Jama Connect® is certified through TÜV SÜD as a software tool for development of medical devices according to IEC 62304. 

Introduction

In May of 2022 a paradigm shift emerged in how In-Vitro Diagnostics (IVD’s) will be developed, managed, and regulated in the European Union (EU). The EU Commission (CE) has developed new regulations named the In Vitro Diagnostic Regulation (IVDR) to replace the previous In Vitro Diagnostic Directive (IVDD). The main goal of the IVDR is to improve upon the quality, safety, and reliability of IVD’s within the European market. This will change the current status quo as IVDR has been predicted to have a significant impact in medical device organizations with IVD sale and business operations.

In this whitepaper, we will provide an overview of the new regulation, discuss some specific topics, and offer considerations for organizations as they adapt to this new paradigm.

Related: The Impact of ISO 26262 on Automotive Development

Overview of the IVDR and The Significant Impact on EU

Figure 1. CE Mark

Prior to the IVDR, the In-Vitro Diagnostics Directive (IVDD) was the governing regulation for devices placed in Europe. Officially adopted in 1997, the IVDD established the regulatory requirements for CE Marking approval for in vitro diagnostics¹. In order to sell and market IVD’s in the European Union, manufacturers need to show compliance with the essential requirements prior to marking the product with the CE label. The CE mark allows for legal distribution
of the IVD within the European Economic Area (EEA)². The CE mark indicates conformity across many different types of products and is based on compliance with specific European regulations based on the product type. See example marking to the left.

For medical devices and IVDs, compliance to the EU Medical Device Directive (MDD) and the EU IVDD was required to obtain CE marking, respectively.

Related: Medical Device: Reduce Project Risk in the Product Development Process

IVDD Overview:

  • IVDD was established in 1997 by the EU for trade within the EEA with 27 EU members plus Iceland, Liechtenstein, and Norway. 
  • IVDD applies to all Reagents, Calibrators, Kit, Instrument, Equipment, Systems used for in vitro diagnostics purposes in the EEA, regardless of origin of design and manufacturing.
  • IVDD is 43 pages providing general requirements. You can read the full document here.
  • Essential Requirements included requirements for design, production, labeling, and the instructions for use (IFU). Some specific requirements included the diagnostic’s analytical sensitivity and specificity, accuracy, repeatability, and reproducibility.
  • There are four general categories that are based on level of risk to public health and/or patient.
    • Annex II List A – Highest risk which require notified body review including HxV’s such as HIV, HBV, HCV
    • Annex II List B – Moderate Risk including IVD’s such as HLA, Glucose monitoring
    • Self-Test – Examples include pregnancy home tests, and cholesterol
    • General – No notified body required as OEM can ‘self-declare’ conformity

Key factors such as the device classification, risk level to patients/public, etc. would determine the manufacturer’s level of approach to developing, manufacturing, and documenting the IVD. A common industry practice for launching an IVD to the global market was that organizations would first launch their products in the EU, and then to broader markets. Due to less rigidity of the IVDD when compared to other countries, it was easier, faster, and more economical for companies to launch there first. The involvement of an external notified body was also less rigid, so many organizations tended to follow the least resistant pathway to market, with many following the ‘self-declaration’/ self-certification pathway. Learnings from the EU launch (e.g., clinical studies) could then be leveraged when then submitting to the more rigid regulatory pathways such as the U.S. Food and Drug Administration (FDA).

This common approach enabled organizations to get new products to the market faster through the regulatory pathway. In the author’s experience, this approach was practiced on many of the IVD’s developed throughout their career in multiple diagnostic applications. The general regulatory roadmap was to have initial launches in EU markets and then proceed with FDA pathway. This provided additional time to work on FDA submission activities since the level of rigidity and documentation was expected to be much higher. However, with the IVDR enforcement now in full effect, it is expected to have a tectonic shift in how manufacturers develop IVDs.

Related: Webinar: Understanding Integrated Risk Management for Medical Device

Compelling Events for Change

As seen with many types of general regulations, changes are commonly in response to mass incidents, generally with negative impact resulting in patient injury and sometimes even death. The US FDA has seen their regulations shift in reaction to mass incidents including the Therac-25 (radiation therapy) and Dalkon Shield (intrauterine device). The accidents led to significant legislative changes to prevent recurrences and improve industry practices to ensure ‘safe and effective’ products.

The emergence of IVDR follows a similar path, where there were European several high-profile events that led to the regulation update. The most notable was the Poly Implant
Prosthesis (PIP) breast implant scandal (based in France) that impacted many patients with high incidents of ruptured implants with unapproved industrial silicone filling. You can read more about the incident here, and the subsequent
clinical recommendations here.

This event led to significant updates to the medical device space with the culmination of the EU Medical Device Regulation published in 2017. Following the MDR initiative, the incumbent IVDD was also overhauled into the new IVDR paradigm which entered into force on May 26, 2017

Stay tuned for Part 2 of this blog series. To read the whitepaper in its entirety, download it HERE.


DOORS Next Gen

Why Modern Engineering Teams Aren’t Using IBM DOORS or DOORS Next Generation for Requirements Management

If you’re currently using DOORS for requirements management, you likely know that moving to a different solution is necessary, and you might be considering DOORS Next Generation. However, fast-shifting market dynamics require a new approach to accelerate innovation. As a modern alternative to traditional legacy platforms, Jama Connect® enables digital transformation with a more efficient and user-friendly approach to managing risk and compliance.

To adapt to increasing industry challenges and complexities, innovative organizations are now requiring best-in-class software to scale development, reduce risk, save time, and ensure compliance to quality and safety regulations — and migrating to a new requirements management tool, will be a necessity to keep pace with the competition.

The leader in requirements management software, Jama Connect outranks IBM DOORS Next®
for implementation time, adoption, ROI, & market presence

 

Related: Why Migration Efforts from IBM Rational DOORS to DOORS NG Are Failing – And an Alternative Path.

5 Key Reasons Teams Are Choosing Jama Connect over DOORS NG

Considering choosing Jama Connect over DOORS Next? Jama Connect consistently stands above DOORS Next (for requirements management tools) in the G2 Grid® for overall satisfaction, performance, user experience, collaboration, reviews and approvals, implementation, usability, user adoption, and overall ROI.

Fastest Time to Market/ROI

  • Deploy in weeks, not months with easy updates and high performance
  • Pre-configured frameworks to satisfy industry regulations
  • Intuitive user interface and workflows that drive efficiency
  • Jama Software in-house industry-focused subject matter experts

Highest Adoptability

  • Intuitive design with a better UX and ease of use that enables adoptability across teams and disciplines
  • Lowest learning curve, minimal training required
  • Actionable visibility into status, progress, and risks
  • Permissions-controlled access for your entire organization

Maximum Collaboration

  • Designed for connecting remote / distributed development teams and disciplines
  • Real-time communication captured in context
  • Secure access for internal and external stakeholders
  • Delivers end-to-end Live Traceability™
  • Improves productivity

Lowest Total Cost of Ownership

  • Simple and straightforward administration
  • No need for custom scripting or continuous updating
  • Scales easily without big infrastructure investment
  • Unlimited no-cost access for extended internal/external stakeholders

Built for the Modern Engineering Stack

  • Jama Connect Traceable MBSE™ encourages and enables MBSE approach
  • Integrates with market-leading tools with open REST API
  • Teams can work in preferred tools with complete traceability visible in Jama Connect

Related: Moving from Modules to Models – Is it finally time to leave IBM® DOORS® behind?

See how DOORS Next stacks up against Jama Connect
in key areas below.

DOORS Next vs Jama Connect

Jama Connect is a proven IBM DOORS and DOORS NG alternative with flexible, scalable, and reliable migration solutions, including:

  • Operation in an IBM DOORS supply chain. Innovative companies leverage Jama Connect to get up and running fast with a modern requirements management process that tightly aligns with industry standards and practices that support regulatory compliance. Organizations can connect to customers and suppliers that use IBM DOORS through Data Exchange for Jama Connect.”
  • Integration services. Jama Connect provides integration with key product development lifecycle tools.
  • Coexists with IBM DOORS. IBM DOORS is embedded in many organizations and may take some time to migrate completely. Progressive teams and divisions can get started on Jama Connect quickly while the larger organization works toward replacing existing programs over time. This approach is supported through a mix of integration, migration, and exchange services.

DOORS has been a faithful requirements management tool that has served the product development community well for almost 30 years. But to stay competitive, it’s necessary to switch to a modern requirements management solution like Jama Connect.

Jama Software®‘s Live Traceability™ allows engineering teams to quickly and easily access the latest and most complete information for any requirement, no matter the stage of development or tools used. This real-time capability boosts productivity by ensuring teams work with the latest data and reduces risks like delays and defects by finding issues early. Research shows that issues found late can be much more expensive to fix, which is why Live Traceability is so important. Jama Connect® helps overcome the limitations of older tools, leading to better results in many industries such as automotive, medical devices, aerospace & defense, and more.

To learn more about making the switch from IBM DOORS or DOORS Next Generation to Jama Connect, download our datasheet.


DOORS for Requirements Management


IBM Rational DOORS

Why Migration Efforts from IBM Rational DOORS to DOORS NG Are Failing – And an Alternative Path.

IBM Rational DOORS was built in 1991 when it became clear that document-based tools such as Microsoft Office did not offer the capabilities able to manage and analyze requirements traceability. And while it was revolutionary at the time, not much has changed about the product in over 30 years.

Many teams are looking to switch away from Rational DOORS because of IT mandates, poor usability due to an antiquated user interface, lack of collaborative features, and a host of other reasons.

However, thinking that migrating to DOORS Next Generation is the easiest, most logical next step is a mistake. In this post, we’ll discuss why many migration efforts from IBM Rational DOORS to DOORS NG are failing, and provide a simpler, more modern alternative.

Considering a switch? If you want to move away from IBM Rational DOORS, you are not constrained by a specific path of migration.

Leaders might already understand the need to switch from Rational DOORS, but they aren’t sure of the next best step. Some lean toward switching to IBM DOORS NG with the assumption that it will be easier to learn and deploy than starting from scratch with a new solution.

However, the only thing that DOORS Next shares with the original DOORS is the name; otherwise, it’s a completely different platform that takes the same level of migration effort that any migration away from DOORS legacy would take. Any expensive DXL customizations — which can sometimes add up to more than a million lines of code — cannot be migrated to DOORS Next.

As you make your decision on whether to migrate away from DOORS or not, consider the risks associated with DOORS and the benefits of choosing a different option.

Risks may include:

  • Loss of control and employee frustration. Employees frustrated with DOORS work outside of DOORS, most often in Microsoft Word or Excel, which means that requirements are no longer maintained in a central system and a rigorous process is not followed. This leads to an inability for management to monitor key metrics for the end-to-end process to identify process risk patterns.
  • Increased operational costs. Continuing the existing path of using DOORS increases an organization’s risk and expense complying with ever demanding IT security regulations.
  • Disruption in business. New users are reluctant to pick up the antiquated user interface of DOORS, expecting software to be as intuitive as applications in their social environment. Not having the ability to move fast and scale business to meet innovative market demands will cost your business time and resources.
  • Missed market opportunities. Errors, defects, and omissions not found until the end of the process cause costly delays and overruns. A company’s long-term success can be hindered by delayed launches and missed market opportunities.
  • Increased exposure to risk in regulated markets. A requirements management tool helps you stay compliant and increase visibility in regulated markets. Limited customer and cross-functional involvement in the review and approval of requirements and a lack of stakeholder alignment create unnecessary risks. And, the absence of process exception tracking, which determines if requirements have been omitted or modified, creates additional exposure. With more stakeholders refusing to use DOORS, compliance is checked after the fact with the arduous task of tool admins importing data and then running trace analysis. Extended stakeholders who are using DOORS are only able to see any errors long after they have been introduced and eventually imported.
  • Distraction from the core business. An ineffective requirements management tool encourages organizations to create customizations rather than simply configuring a tool to meet process needs. Developing and maintaining ad-hoc customizations forces an organization to focus on how to create requirements management functions rather than focus on core business. A modern requirements management solution enables teams to work faster and more efficiently, leading to faster time to market.

Related: The Inside Story: Data-Model Diagnostics for IBM® DOORS®

Need more proof? Here’s what IBM says about migrating from IBM Rational DOORS to DOORS NG

Looking at Rational DOORS and DOORS NG Side-by-Side

It may sound like migrating from Rational DOORS and DOORS NG is just a click of a button, the two systems have completely different infrastructure, processes, and structure. It’s a very complex and manual process. In fact, migrating to DOORS NG will cause major architectural shifts that will impact performance and require extensive employee training.

DOORS

Related: Requirements Traceability, Does My Data Matter?

There are a number of data types, including historical data, that can’t be migrated at all. But don’t take it from us; IBM says it themselves.

Additionally, there is no upgrade path from Rational DOORS to DOORS NG

5 Common Migration Myths Debunked

Transitioning to a new solution doesn’t have to be challenging; however, there are some assumptions that mislead us into thinking that difficulty is inevitable. Consider the following myths:

MYTH 1: Migrating away from IBM solutions will be more expensive. The amount of work that goes into upgrading to DOORS Next or transitioning to a new RM solution is the same, differentiated only by the quality of the tool and services available to help with migration. An option other than the DOORS family is most often a better fit for your organization.

MYTH 2: Customization will carry over to DOORS Next. You spent a lot of time customizing IBM DOORS and may believe those customizations will transition seamlessly to DOORS Next. However, this isn’t the case and is the reason selecting a different solution doesn’t involve more work.

MYTH 3: DOORS is already deployed and cheap to maintain. Continuing the current path with IBM DOORS is an expensive option in the long term, and often requires dedicated personnel. Switching to an alternative RM solution can improve efficiency while saving money.

MYTH 4: Business disruption is too difficult. The right RM tool will empower teams to effectively hit deadlines, collaborate, and improve business outcomes

MYTH 5: The user experience will suffer., Many people refuse to use DOORS due to a challenging user experience. DOORS Next is a completely new tool with a new user experience. Adopting a user-friendly solution allows teams to collaborate far more effectively as team members can accelerate concepts, designs, and validations for faster times to market.

Related: Moving from Modules to Models – Is it finally time to leave IBM® DOORS® behind?

Migration Away from IBM Rational DOORS is Inevitable – Here’s An Alternate, Easier Path

The fact is, IBM DOORS is extremely outdated, and at some point, updates and support will inevitably end.

If you’re currently using DOORS, you likely know that moving to a different solution is necessary, and you might be considering DOORS Next. However, fast-shifting market dynamics require a new approach to accelerate innovation. As a modern alternative to traditional legacy platforms, Jama Connect® enables digital transformation with a more efficient and user-friendly approach to managing risk and compliance.

Customers agree, naming Jama Connect the overall leader (#1) in requirements management software on G2, outranking IBM DOORS Next for implementation time, adoption, ROI, and market presence.

Jama Connect is a proven IBM DOORS alternative with flexible and reliable solutions, including:

Operation in an IBM DOORS supply chain. Innovative companies leverage Jama Connect to get up and running fast with a modern requirements management process that tightly aligns with industry standards and practices that support regulatory compliance. Organizations can connect to customers and suppliers that use IBM DOORS through Data Exchange for Jama Connect.

Integration services. Jama Connect provides integration with key product development lifecycle tools.

Coexists with IBM DOORS. IBM DOORS is embedded in many organizations and may take some time to migrate completely. Progressive teams and divisions can get started on Jama Connect quickly while the larger organization works toward replacing existing programs over time. This approach is supported through a mix of integration, migration, and exchange services.

Are you considering DOORS for requirements management or considering making a switch? Learn more in our eBooks, Why Move Away from IBM® DOORS® Legacy, and Why Now? and Moving from DOORS Next® to Jama Connect® for Requirements Management

Achieving Live Traceability™ with Jama Connect®

Jama Software®‘s Live Traceability™ allows engineering teams to quickly and easily access the latest and most complete information for any requirement, no matter the stage of development or tools used. This real-time capability boosts productivity by ensuring teams work with the latest data and reduces risks like delays and defects by finding issues early. Research shows that issues found late can be much more expensive to fix, which is why Live Traceability is so important. Jama Connect® helps overcome the limitations of older tools, leading to better results in many industries such as automotive, medical devices, aerospace & defense, and more. To learn more, visit Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

To learn more about the three flexible approaches to support companies moving away from IBM DOORS and how our migration team can help, download our datasheet.


DOORS for Requirements Management


reqif

Supply chain collaboration: Interactive or ReqIF. Which is right for you?

There are two main types of requirement collaboration in the supply chain: Interactive and ReqIF. While interactive collaboration is on the rise and offers the most benefits, there are cases where it is not feasible. Jama Software supports both methods and, in this post, we will discuss each method’s use-case and pros/cons.

Interactive Collaboration: The High-fidelity Option

We all know that collaboration in product development helps improve quality, reduces risk and speeds up development. For this reason, Jama Connect® has context-based, interactive collaboration built into the platform. Reviews are a formal, effective collaboration method that guides teams in fulfilling regulatory requirements.

In addition to using these industry leading capabilities in-house, our customers frequently use these capabilities to collaborate with external stakeholders. For instance, Jama Connect allows you to invite reviewers simply by email (Jama Connect licenses include more than enough reviewer licenses for this purpose). This works extremely well in practice. In fact, one medical device developer, RBC Medical Innovations (now known as Vantage Medtech), was able to shed hundreds of team-member days during development to save $150,000 in cost savings per project.

As a fully web-based software as a service (SaaS) product, Jama Connect offers customers a standard and secure web interface for cross-department or cross-company collaboration. Inviting customers or suppliers into your Jama Connect system is as easy as sending an email. User security can limit what is seen and allows for granular control of permissions. Our full version tracking enables everyone to see what has changed, who changed it and all impacts on upstream/downstream traceability.

RELATED: The Limitations, Drawbacks, and Risks of Using Legacy Requirements Management Tools

The Alternative: Controlled Data Exchange via ReqIF

Data exchange between organizations is nothing new, and many organizations have collaborated for decades, typically by exchanging documents. While this approach technically works, it results in unstructured data that provides no traceability, no understanding of changes between versions and no easy way to provide structured feedback.

The automotive industry is a great example of complexity across the supply chain with OEM’s traditionally working with hundreds of suppliers. It’s not unusual to find tens of thousands of requirements in an automotive specification, so managing these requirements is a challenge. In response, the industry developed an international standard for the lossless exchange of requirements called Requirements Interchange Format (ReqIF) and the standard was finalized in 2011.

A requirements exchange with ReqIF has some similarities to the old (and dreaded) document exchange process: One party exports a ReqIF file and hands it to the other party. The transfer can happen via a portal upload, automated exchange or even as an email attachment.

But here’s where the similarities end: A ReqIF file contains structured requirements data consisting of individual requirements with visibility into structure, attributes, related elements, and traces. ReqIF also supports incremental updates. If one party creates another version and exports a month later, you could import that version into your environment and the tool would show you clearly which elements, attributes, and traces have changed. For instance, you could use suspect links to re-validate only those items that have changed. Compared to trading .pdf files, which yes believe it or not many organizations still do, this is an extremely significant time saver and error avoiding capability.

While the standard is certainly more advanced than simple document sharing, it does have drawbacks. Not every tool adheres to the standards in the correct way. Data exported can be missing embedded images, required fields in one system are not required in another and user information (meta-data) is not universally available.

 

RELATED: Jama Connect in the Digital Engineering Ecosystem

Collaboration via ReqIF

ReqIF is commonly used to solicit feedback from a supplier. A producer could export the requirements for a supplier, including attributes for providing status feedback and comments. The supplier would then import the ReqIF file into the tool of their choice, where they could fill out the supplier attributes and send the resulting export back.

In addition, they could start integrating the imported requirements into their own development system. For example, they could establish traceability from the customer requirements through to design while keeping the process invisible to their customer.

Image Source: IREB Magazine

There are other use cases that ReqIF supports as well, but for all of them, the foundation is a controlled asynchronous exchange of structured requirements that keeps individual items, attributes and traces intact. Jama Connect supports this workflow and we have many customers that are using it today.

Bottom Line: How to Collaborate?

If you are using Jama Connect, the built-in collaboration capabilities are the most effective way to work together. Having 100% Live Traceability™ has been proven to increase product quality while reducing time to market.

However, if you are working with people outside your organization, that may not be able to collaborate using your Jama Connect instance a ReqIF-based collaboration could be an acceptable alternative.

Learn more about the benefits of upgrading your requirements management process with our paper, “Getting the Most from a Requirements Management Tool.”


DOORS for requirements management

Considering DOORS® for requirements management? There is a more modern solution.

If you’re considering IBM® DOORS® for requirements management, it might be because it’s considered a “safe” move, you’ve used it in the past, or because you’re unaware that there’s a significantly more modern and easier to use alternative to DOORS requirements management.

IBM DOORS was an amazing tool – when it was originally published in 1991, over 30 years ago. DOORS for requirements management has many capabilities for working in regulated industries, but the limitations far outweigh the benefits. It does not deal well with increasing complexity or the need for collaboration and seamless integration in existing tool ecosystems. Let’s have a look at some of the limitations of DOORS:

Traceability: DOORS has powerful traceability capabilities, but they are hidden behind a cumbersome interface. This leads to outdated traces. Users find traceability maintenance to be difficult with DOORS, and sometimes traces are created “after the fact” for compliance audits and nothing else. This is a missed opportunity. Having a more modern tool, like Jama Connect® with an easy-to-use traceability matrix creates transparency and confidence when reacting to change. Traceability also enables agility.

Related: What is Requirements Traceability and Why Does it Matter for Product Teams

Change Management: The traceability of DOORS does support change management, e.g., via suspect links in principle. Unfortunately, this information is hidden and hard to utilize. Compare that to the actionable traceability of Jama Connect, which proactively points out issues in the traceability matrix and suggests how to fix them, instead of doing this reactively, after-the-fact.

Compliance Reporting: DOORS requirements management allows you to report on virtually everything – but almost everything requires custom scripting with its proprietary scripting language, DXL. Unless you have a responsive (often costly) programmer on your team, you will have a hard time getting the information you need, when you need it.

Best Practices: Every “module” (document) in DOORS has its own fields, and without an in-house expert, users sometimes find themselves with little guidance on how to use the tool. This results in inconsistencies, which in turn results in confusion and lack of transparency. Consider two “system specifications” with inconsistent data values for “priority.” Likewise, standardized workflows guide users through their daily work. In DOORS, you need a programmer to provide this functionality.

Related: Requirements Traceability, Does My Data Matter?

Market Drivers Are Pushing Engineering Teams and Technology to Evolve Past IBM DOORS’ Capabilities

Today’s products and software have become more complex. This complexity, combined with rapidly evolving customer and market demands, is forcing engineering teams to change the way they work. Now, far more stakeholders need to get involved in the requirements, driving the need for requirements tools to be more collaborative and have functionality that is applicable to diverse users.

Organizations that successfully transform to support this new way of working understand that effective and optimized product and system development requires highly collaborative solutions and methodologies.

To reduce risk in product development while still accelerating system design and delivery, teams need access to real-time data and alignment across disparate teams as well as across engineering, business, and product management lifecycles.

Leading-edge companies who are successfully supporting transformation of their engineering teams:

  • Invest in new technologies and agile processes to continually improve product development: Engineering teams prefer to make their own decisions about which best-of-breed solutions support their specific discipline and optimization of their activities – one single tool will not fit all users’ needs. It’s no longer possible for a Prime Contractor or OEM to mandate a single product or vendor across supply chains, and in fact, standards such as ReqIF (Requirement Interchange Format) and OSLC (Open Services for Lifecycle Collaboration) have come about to help products work better together. Modern development solutions prioritize integration across the ALM-PLM ecosystem.
  • Take a data-driven approach to product development: An organization’s investment in their data is far more than the investment they make in tools, and the primary focus now comes down to availability of data and how that flows across an engineering community (integration) and the value chain (exchange). What is required is a loosely coupled approach that ties together the necessary metadata across disparate tools in a way that connects the desired outcome (user and system requirements) to downstream activities – the digital thread. The digital thread is the best approach to reduce the risk of negative product outcomes while preserving engineering autonomy and productivity.
  • Support more formal processes to address increased regulation: As product complexity increases, so has the need for more formal processes and compliance with industry standards. Best practices for systems engineering have been prescribed in many industries. This formal process adoption started with the need to comply with aerospace standards such as DO178 or ISO 9001. Now we see engineering regulation or compliance needs increase across automotive, medical, finance, and other industries, which require the same level of rigor in their development process. Investment in tools that support the generation of the necessary proof of-process compliance to standards, most commonly: requirement validation, verification, traceability, risk assessments, and test results, are critical to supporting efficiency while reducing risk.

Related: What is DOORS and Why Does DOORS Software Fall Short for Requirements Management

IBM DOORS for Requirements Management vs. Jama Connect

Today’s product development teams must innovate and adapt quickly to changing market demands in order to remain competitive. Many find legacy solutions like DOORS are unable to adapt to support these needs. The following are the top reasons why some of the world’s most forward-thinking companies are electing to switch to Jama Connect:

Easy to use, intuitive modern user experience

Jama Connect supports multiple development methodologies and engineering disciplines to drive cross-team collaboration and alignment.

Flexible, scalable, and secure deployment models that provide manageable total cost of ownership (TCO)

Jama Software offers flexible license and deployment models with unlimited licenses for reviewers to promote collaboration across product development teams. Deployed in the cloud or on-premise, the solution ensures flexible access for distributed teams anywhere.

Open architecture to integrate with the tools teams want to use

Jama Connect enables integration with best-of-breed tools across the entire product development lifecycle. We provide a powerful network of options to get the right technology stack aligned to meet each client’s unique business needs.

Achieving Live Traceability™ with Jama Connect®

Jama Software®‘s Live Traceability™ allows engineering teams to quickly and easily access the latest and most complete information for any requirement, no matter the stage of development or tools used. This real-time capability boosts productivity by ensuring teams work with the latest data and reduces risks like delays and defects by finding issues early. Research shows that issues found late can be much more expensive to fix, which is why Live Traceability is so important. Jama Connect® helps overcome the limitations of older tools, leading to better results in many industries such as automotive, medical devices, aerospace & defense, and more. To learn more, visit Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

Are you considering DOORS for requirements management or considering making a switch? Check out this webinar, Moving from Modules to Models – Is it finally time to leave IBM® DOORS® behind? Watch it here

DOORS for Requirements Management