Tag Archive for: traceability

Remote Workforce

Editor’s Note: This post on ways traceability has changed to support the remote workforce was originally published here on DevOps.com on June 24th, 2020, and was written by Josh Turpen, Chief Product Officer at Jama Software.


Traceability has always been a useful tool in the development process, but it has become especially important since the COVID-19 outbreak and the increased remote workforce.

Where developers and engineers were once working side-by-side, with the ability to discuss their process and keep their team informed, they are now navigating a remote collaboration landscape. According to a 2017 study done by Stack Overflow, there is a correlation for developers between remote work and job satisfaction, and the highest job satisfaction ratings are seen from developers who work remote full time. As technology has grown to make this process easier, remote working is expected to become a norm.

Advanced traceability has the potential to hold teams together by allowing increased visibility into each move throughout an entire project. Without traceability, it would be nearly impossible to keep remote teams aligned and on schedule.

Product development tools have continuously been forced to evolve to keep up with the multi-dimensional nature of requirement, test and risk management. For these processes to be successful, all related variables must work together continuously, at scale, and across teams.

We’ve only just started to see how traceability tools can use updated capabilities to streamline the product development process, but we know enough to discuss two things: what’s happening now and what the future may hold.


RELATED POST: Requirements Traceability – How To Go Live


Traditionally, traceability could be compared to a map. While not limited to a single view, maps exist to help you navigate your way to a destination. Similarly, traceability leads product developers through every step of their processes, eventually helping them reach their goal. If your map was constantly changing you’d never be able to figure out where you were going, but what if people ahead of you could update it as they went along? This would keep you in the loop of the upcoming twists and turns, and no one would feel blindsided. Traceability makes it easy to share similar production changes with your entire team, all at once.

In the traceability process, links are built automatically which lets major decision points, reviews and approvals be captured in final documents and reports. This allows for faster and more informed decision making and these live references can exist across versions.

With the switch to remote work across the globe, and no immediate end in sight, developers don’t have the option of working side-by-side with their colleagues. Because of this, it is pertinent that they are able to streamline their work in every way possible, and increased traceability is expected to be a pillar of that transition.

At the end of the day, connecting the dots is all about making sense of everyone’s decisions. Why did they follow that process, and what factors led them to make the choices they made?

In the early days of traceability there wasn’t always room to include every piece of information that you might find relevant down the line. Legacy tools such as the act of manual reporting through Word documents left much to be desired. Today, that’s becoming less of an issue, as developers are allowed more meaningful accountability and insight into interconnections as they happen.

As we look ahead, we can expect to see these capabilities grow in five different ways.


RELATED POST: Building An Audit Trail Through Live Traceability


Less Manual Effort

Updating your traceability reports with as little manual effort as possible will be essential to a streamlined, remote workforce. As traceability becomes more advanced, the work to create and maintain it should not become more difficult.

More Nuance Captured, Related and Parsed for Meaning

Improvements in software will make data gathering more precise, and increase the number of items a team can consider relevant, traceable information. This will take additional workloads off of the developers as more items are automatically traced and easily accessible.

More Attributes Can Define and Predict a Project’s Success

If you have a more data-rich, detailed record of activities, it is possible to understand the past with more context and less reliance on costly manual documentation or memory.

Dispersed Systems Holding Relevant Information Will Start to Feel Closer and More Interconnected

Through more dense integration and aligned processes, systems feel more controlled and connected, giving users a more seamless experience.

Expansion of Communication and Review Capabilities for Stakeholders Who May Be Impacted by Changes

The availability of a full audit trail of participation will make a big difference in the ease of the review process. The ability to easily see who is impacted by changes will allow teams to proactively manage the effects of said changes.

In response to the COVID-19 pandemic, and the number of companies who are maintaining their remote work policies, we can expect to see more innovations related to product development workflows. These innovations will enable easier remote collaboration between colleagues and across teams, overall streamlining the product development process.

Jama Connect’s Requirements Management Enables Live Traceability™ Across Your Development Process

Bridge engineering siloes across development, test, and risk activities. Provide end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning requirements management platform. Learn more! 


Want more best practices and tips? Watch a recording of our webinar, “Ask Jama: Best Practices for Remote Collaboration with Jama Connect.”

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Jama Deminar SeriesWith over 12.5 million active users, organizations around the globe rely on Jama Connect to help bring complex products to life. Innovative companies choose Jama Connect to improve quality, reduce rework, prove compliance, and get to market faster.

That’s why we’re excited to announce a six-part series of deminars (yes, you read that right – it’s a demonstration webinar!) where we’ll be giving you an inside look at the leading platform for requirements, risk, and test management. In this deminar series, we’ll cover key features and capabilities, seamless integrations, best practices, and more.

Below is a snapshot of when each deminar will happen, what will be covered, and how you can save your spot.


Product Essentials: A Quick Tour of Jama Connect for Modern Requirements Management

Thursday, September 10 – 8:00 a.m. PT | 17:00 CEST

Jama Connect enables consistency, collaboration, and alignment across the enterprise by providing a continuous flow of accurate requirements information. This webinar demonstration tour provides an overview of the Jama Connect platform.

In this demonstration session, you’ll learn how to:

    • Establish alignment across people, process, and technology to establish a single source of truth around digital requirements management
    • Collaborate across both internal and external teams using Review Center
    • Use traceability views to provide visibility across the entire product development cycle
    • Utilize our common integrations to extend the solution capabilities — including JIRA
    • Use Jama Connect to support testing, change management and impact analysis

Product Essentials: How to Streamline Reviews and Collaborate with Remote Teams, Customers, and Suppliers with Jama Connect.   

Thursday, September 24 – 8:00 a.m. PT | 17:00 CEST

Through structured collaboration in Jama connect, teams can source feedback from distributed teams and collect side-conversations in an actionable way to gain cross-team visibility.

In this demonstration session, you’ll learn how to:

  • Easily establish communication and document decisions across virtual teams
  • Immediately notify and prioritize critical decisions and pull in required contributors throughout the development process
  • Hold formal reviews and document those decisions in Review Center
  • Exchange requirements with remote teams, customers, and suppliers to extend the development process beyond your core team

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Product Essentials: Unpacking Requirements Traceability Capabilities of Jama Connect

Thursday, October 8 – 8:00 a.m. PT | 17:00 CEST

In this session you’ll learn how Jama Connect capabilities provide requirements traceability which improves product development accuracy and/or quality and ensures the ability to provide trace reports for audits. Learn how various options are used to track relationships to/from/between requirements and understand the full impact across the project.

In this demonstration session, you’ll learn how to:

  • Create relationship guardrails to ensure traceability rules will guide users and prevent dependency chaos
  • Right click to build relationship dependencies as you perform everyday work activities
  • Use trace view to:
    • Identify relationship dependencies between data
    • Track progress and identify missing work items
    • Analyze potential impact of changes
    • Gain visibility needed for prioritizing lower level work items against higher level requirements
  • Use item widgets to:
    • View impact analysis to understand the potential impact of change
    • Initiate conversations between connected users
    • Export relationship dependencies to support compliance audits

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Product Essentials: Using Jama Connect and JIRA to Manage Requirements for Software Development Teams

Thursday, October 22 – 8:00 a.m. PT | 17:00 CEST

In this session you’ll learn how Jama Connect provides the ability to link JIRA tasks and defects to requirements for full transparency, traceability, and change management throughout the software development process. Product and engineering teams can connect product planning to execution and stay in sync to ensure accuracy and quality of work.

In this demonstration session, you’ll learn how:

  • Link issues and defects from JIRA to Jama Connect
  • Support conversations across the team between the requirements and epics throughout the software development process
  • Analyze—at a dashboard level—the state of the tests, stories, and epics related to a project
  • Use the two-way integration between Jama and JIRA to allow the flow of information back and forth across the teams with synchronization, providing a single source repository and full traceability

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Product Essentials: Sharing How Jama Connect Allows for Earlier Testing in the Lifecycle to Increase Quality and Efficiency.

Thursday, November 5 – 8:00 a.m. PT | 17:00 CET

Through testing in Jama connect, teams can achieve value by incorporating the results of the test strategy into the product strategy and identify potential defects earlier in the product development lifecycle, which prevents late stage changes leading to costly rework.  Learn how Jama Connect provides full manual testing capabilities tied into the product development process ensuring that you release a best-quality product that meets customer expectations.

In this demonstration session, you’ll learn how to:

  • Create a test case and configure filters to quickly access requirements that have no test coverage
  • View test cases, the tests associated, and test run results to analyze test coverage and easily view any gaps
  • Log defects from the testing interface and view automatic trace relationships
  • Export reports to support compliance activities

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Product Essentials: Working with baselines in Jama Connect to Facilitate Compliance and Reuse in Product Development.

Thursday, November 19 – 8:00 a.m. PT | 17:00 CET

Learn how to view and create a baseline to capture and preserve the project at a single point in time. This supports compliance and enables reuse in product development projects.

In this demonstration session, you’ll learn how to:

  • Coordinate product releases across teams and projects
  • Easily create a baseline release and track it effectively throughout the development of the product
  • Navigate the workflow across teams to support release schedules
  • Use baselines to fulfill regulatory requirements (with respect to record keeping) by producing a clear and readable audit trail.

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To view the full series, watch recordings of the deminars after they happen, or register for individual deminars, visit our Product Essentials page.

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Product Development Lifecycle Management

Product development lifecycle management is the handling of the entire lifecycle of a product, from its earliest stages of concept development to its eventual production and use in the market. Effective strategy and execution across the lifecycle requires preserving quality while working within constraints on cost and time. A key component to successful product development is managing your requirements from start to finish within a system that allows for complete traceability and collaboration throughout the development process. A requirements management solution that enables live traceability, real-time collaboration, flexible development methodologies and hierarchical organization will ultimately lead to an improved product development lifecycle.

The Importance of Live Traceability

From the early stages of a product’s development all the way through its go-to-market execution, product development teams need to understand how their different requirements and tests are traced to each other throughout the process, in order to effectively manage compliance, track changes, and ensure product quality. The right solution should enable visibility across the product development lifecycle, so that team members can:

  • See the impact of change before it happens and adjust as needed
  • Automatically trace your requirements as you create content, reducing non-value time
  • Keep track of test coverage one convenient place
  • Automatically have guardrails that alert you to any gaps in your product development
  • Easily view and navigate upstream and downstream relationships
  • Create a clear audit trail to support the development of complex, safety-driven products
  • Export your trace matrices easily to help with proof of compliance

So how do these types of features work in practice? Let’s examine how live traceability functions in specific ways within Jama Connect.

Navigating Change Management and Impact Analysis

Too often data in complex product development remains in siloes, creating misalignment, lack of visibility, and difficulty to assess the impact of change. With objects traced in Jama Connect, you have the ability to perform an impact analysis which enables you to review the impact of each change to a new or existing product before it’s actually made. Changes happen to requirements and other artifacts all the time, which is why it’s important to be able to create baselines.

Additionally, the platform can reactively and automatically mark items as “suspect” when they are downstream from a modified item. Teams can then review a running listing of items needing further evaluation that may need to be evaluated for impact.

Relationship rules also enable you to track items within the same project or across multiple projects, using a visual schematic for representing the different artifacts traced throughout your development process.

Jama Connect can take a snapshot that documents the detailed status of a project, or any subset of a project, at a designated point in time, also allowing you to maintain meaningful comparison and overall traceability.

Multiple versions of a product requirement can also be compared, side-by-side, to see what changed. Through such visualization, teams can easily see how requirements have iterated over time and what led to those changes.

Diving into Test Management and Traceability

QA teams need the power to trace test results back to their corresponding requirements. In Jama Connect, these teams can perform manual testing, create and organize test plans with groups of test cases, dashboards, and view test-related reports throughout the product development process. They can also:

  • Organize testing information to support an iterative verification process
  • Identify missing test coverage and take action to close gaps
  • Reuse validated requirements saving time when testing across multiple product versions or variants.
  • View real-time, consolidated data about test plans, associated test cycles, cases, and test runs to-date
  • Perform all of these actions from the same interface

The end result is reduced risk throughout the product development lifecycle, along with increased product quality. For example, the ability to log failures and defects allows for the creation of trace relationships that make it easier to resolve the issue in question.

Meanwhile, out of the box reports and dashboards provide straightforward visualizations of the progress of the test management process, including how tests trace back to their requirements. That helps simplify industry compliance, as it is easy to show auditors  the connections between requirements and tests along with associated results.


RELATED: Five Tips for Requirements Traceability


Adding Power Through Integrations

An RM, test, and risk platform ensures that no project-related stone is left unturned, not only through the test management capabilities above, but also through wide-reaching integrations.

In Jama Connect, you can integrate with industry leading solutions providing a flexible, scalable solution when automated testing is necessary in the product development lifecycle. Pull in automated test results from other sources using Jama Connect’s integrations with popular solutions such as Tricentis: qTest, LDRA, Vector, Testrail, and ANSYS, as well as its Open REST API.

The Role of Real-Time Collaboration

The product development lifecycle requires collaboration between multiple stakeholders and teams, along with the efficient capture of stakeholder feedback and other standardized data during the requirements review and approval processes. Teams must be able to share, confirm, and iterate on product requirements and specifications, determine acceptance criteria, and coordinate engineering responses in real time, including prioritization capturing electronic signatures for approvals – ideally from a common place.

In reality, real-time collaboration is hindered by disjointed processes and discrete documents.

Review Center within Jama Connect provides a streamlined alternative, allowing you to gather and incorporate feedback from the relevant project stakeholders, track a review’s overall progress and view team statistics to determine which requirements have the most issues to address.

Managing Approvals and Electronic Signatures

Reviewers can join in conversations and mark items as “Approved” or “Needs More Work.” Use electronic signatures to demarcate the different stages of the product development process, establish roles between “Reviewers” and “Approvers” and export approved reviews to more effectively prove compliance. Each signature captures the time and date for auditing purposes, making it very straightforward to tie them back to their corresponding individuals or stakeholders.

Effective collaboration and engagement throughout the product development lifecycle has numerous benefits. With the right platform and setup, you can shorten milestone phases and development cycles, help teams better identify risks and opportunities and improve overall time to market.


RELATED: Streamlining Requirements Reviews: Best Practices for Moderators, Reviewers, and Approvers


Stream Discussions and Assign Responsibility

Jama Connect allows you to stream discussions bringing both internal and external stakeholders into the conversation easily without needing to navigate deep into the requirements management platform. A conversation can be easily expanded to encompass the necessary users and stakeholders and communicate key actions items to them. A user can respond to a conversation without even accessing the application proper, allowing them to add to a threaded and contextual exchange with ease.

Along similar lines, Jama Connect helps you see who authored, edited, commented on, or was mentioned in any given item. These details allow for quicker, more targeted action, for instance if a requirement changed and needs to be updated right away. The responsible parties, whether a developer or QA lead, can be notified and supplied with the relevant context.

Reusing Requirements to Save Time and Increase Consistency

Products often share requirements, so why not reuse them once approved? Efficient reuse requires the right platform for cataloging all the specific requirements in question and keeping them in sync across the organization.

Traditional document-based product development lifecycle management is an obstacle to reuse. Adding in a modern platform is a good step toward greater consistency in how you reuse your requirements and in turn shorten time-to-market by eliminating rework and manual processes.


To learn more on the topic of requirements management, we’ve curated some of our best resources for you here.

 SEE MORE RESOURCES

This post is the first in a three-part series on traceability. Keep an eye out for the second two posts on how requirements traceability will be different in the 2020s, and lessons learned from 2010s Agile product development.

There are new software capabilities being developed every day keeping us dazzled with trend-driven analytics and massive data analysis. At the end of the day though, it’s humans that are still accountable for the product development decisions being made with or without cutting-edge analysis tools. Even with the advancement of automated analytics, decision-makers must still demand good information so they can truly own their choices in complex product development.

Making good decisions depends on the ability to see comprehensible information as change happens in real time, both within your team and throughout the system your product exists in. That’s where modern traceability comes in – it makes it possible to manage and respond to change in a systematic, auditable, confidence-enhancing way.

Rather than trying to prevent change (still impossible with our current technology for now…), here are three ways traceability has evolved to support the dynamic job of decision makers.

Evolution 1: Modern traceability can capture when you actually make a decision, in multiple formats from both formal and informal situations.

Decisions have varying levels of durability, and it’s not always obvious at the time what that level is. Sometimes you know at the time you’re making a final, consequential decision. Other times you make what you think is a temporary choice and you’re living with it 5-10+ years later. Given that uncertainty, having mechanisms to see when decisions are made (throughout the development process) is essential when products are expected to be maintained for years. We may need to move on quickly in the development process, but the record can live on for future context.

In Action: Formal decision processes such as gate reviews can be managed in tools like Jama Connect™ Review Center, making it easier to mark versions of requirements as signed-off and complete. Decisions that arise from less formal activities like comment threads on requirements can be tagged and referenced later to piece together thinking from the past.

Electronically sign-off on formal reviews using Jama Connect Review Center.

“Catching these traceability gaps would’ve probably taken hours or days in our old system, while with Jama, it became obvious in a matter of minutes.” Read how Jama Connect improved Össur’s traceability process.

Evolution 2: Modern traceability connects people to the context of what they’re working on as they go – not just globally or in a matrix after the fact.

Traceability gives people a (specific) reason to care when asking for input. It helps everyone know why they’re there. Rather than rely on sharing lengthy Word documents or running general meetings, precise outreach is possible with precise mapping of work items (including their owners and contributors) to each other.

In Action: Figure out who to direct questions to or notify by looking at interconnected people, not just the work items. This list can be automatically generated with Jama Connect’s connected users feature – so knowing who to contact won’t slow anyone down from having timely conversations.

See who’s related to each item with connected users.

 

Evolution 3: Traceability can show past decisions, because they’ve been captured all along.

Can you follow any thread of a question or item to how it got there and why? Knowing who made a decision, and what information *they* had access to is as important as the information itself. Your traceability is incomplete if you can’t piece that together. The faster the better. The responsible thing to do: Make the task of keeping useful records low friction. It doesn’t need to be forced behavior if it’s captured along the way as a biproduct of doing your job.

In Action: Building technical requirements directly from primary source materials, like high level market requirements, has multiple benefits. It simplifies the authoring process by having the downstream requirements writing right next to the source materials, so the translation step is that much easier. It also ensures that when something changes downstream, features like Jama Connect’s suspect links can show where those changes impact other work in real time – no need to wait for an event to reconcile the original goals with what was built.

View the context of how decisions were made with commenting in single-item view.

Traceability can be used to support more genuine accountability. Without robust, modern traceability tools accountability is incomplete — past decisions can’t easily be seen, learned from, or built upon when new choices are made. It’s much harder to legitimately hold someone accountable when they’re working in the dark.

To go deeper on the topic of traceability, and how Jama Connect helps fast track the process, check out our eBook, “The Jama Software Guide to Requirements Traceability.”

Ossur uses Jama for Medical Device Development

In medical device development, control of quality and risk is heavily driven by regulatory requirements. Compliance with international medical device standards like ISO 13485 and ISO 14971 can drain resources and reduce operational agility if the means of demonstrating compliance are not agile themselves.

The more complex the project, the higher the risk. And the higher the risk, the more stringent the medical device compliance procedures. Managing hundreds of requirements in a document-based system without traceability becomes a major chore.

Össur, a global leader in non-invasive orthopedics, had for several years been relying on an internally developed document-based process to manage its product requirements. While their system had been working as intended, they felt there was an opportunity to streamline procedures and compliance tasks.

The Costs of a Rigid Requirements System in Medical Device Development

Continually evolving its processes has always been a key to success for Össur, whose cutting-edge prosthetics technologies have been showcased in publications like Popular Science and have been worn in competition in the Olympic Games. They examined their development cycle for inefficiencies and noted their requirements process unfolded in a sequential manner that was costing them an enormous amount of time and effort.

In specifying a highly complex Össur medical device, several engineers would collaborate on drafting requirements and compiling the requirements document. The document would then be circulated for review. Once approved, the requirements would be verified. If any requirement needed to be added or changed, however, the entire review and approval cycle had to be repeated.

“Our old system was very rigid,” said David Langlois, Director of R&D for Bionic Solutions at Össur. “The minimum effort was always quite high, which means the overhead was also high.”

Össur knew it was time for a change. They wanted something that was as close to a turn-key solution as possible — one that would provide traceability and dynamic content management, and would be scalable across their organization. Plus, it needed to be capable of handling the complete development chain — from requirements through verification and validation, along with easing the path to compliance to ISO standards like ISO 13485 and ISO 14971 — for a diverse product line.

After evaluating several alternatives, including some designed specifically for medical device development, Össur chose Jama Connect™.

 Learn more about how Jama Connect helps teams improve medical device development.

Replacing Process Rigidity with Speed and Agility

Össur began using Jama Connect in 2018, starting with a small group of developers working on bionic lower-limb prosthetics. They immediately began seeing dramatic improvements in their process, especially in the areas of traceability, impact analysis, and test management.

As soon as they began importing their data into Jama Connect, Össur’s engineers saw they had traceability gaps. “Catching these gaps would probably have taken hours or days in our old system,” says Langlois. “With Jama, it became obvious in a matter of minutes.”

With Jama Connect’s impact analysis, teams can quickly gain an accurate understanding of the implications of a proposed change. So, in turn, they can make better informed business decisions. “That brings a lot of value when you’re trying to run a review, and you want to know whether you have gaps in your test coverage,” says Langlois. “With Jama, it’s a five-minute question instead of one that takes hours.”

In addition, Össur feels Jama Connect’s test coverage and built-in metrics are making its testing process far more predictable and efficient. “One thing that’s very powerful about Jama Connect is that, after a few test runs, you can actually quantify pretty accurately what sort of effort is required,” Langlois says. “Jama provides all these metrics that allow you to identify where your bottlenecks are, giving you a better understanding of where the time is going and where you’re losing money.”

Leveraging Jama Connect’s Flexibility for a Faster, More Flexible Future

As Össur branches Jama out into other areas of its organization, it plans to allow individual teams to configure Jama Connect in a way that best suits how they work. And Össur is already thinking about ways to integrate with some of the other solutions it’s currently using.

“As a software developer, I think Jama Connect’s integration with Jira is going to be very useful for me,” says Matthías Kristjánsson, Product Lead Designer at Össur. “Today, we actually make duplicates of our requirements into the Jira system. Being able to connect them straight to Jama and remove that step — so they’re directly connected to a requirement or specification — will be valuable.”

Read the full case study to learn more about how Össur is using Jama Connect to grow more agile and efficient and assure compliance with relevant regulatory standards.

Traceability is the tracking of requirements across the product development cycle. It documents the status of everything being worked on and shows the history of development along with the impacts of specific changes. Its benefits include easier regulatory compliance, more in-sync teams, and higher-quality releases.

A dedicated software traceability solution may be relied upon to systematically track and trace a requirement’s life. Compared to using discrete documents (e.g., spreadsheets) for the same purpose, this type of centralized platform lets teams make easier, more accurate assessments that support more informed decisions about products. It can dependably identify who made each change, what the change entailed, and why it was made – all in one system of record.

Accordingly, such a platform enables superior software requirements testing and management, in industries as varied as medical device manufacturing and automotive production. Let’s look at five tips for how to improve requirements traceability, along with how traceability software helps with each one.

1. Use Real-Time Communications To Empower Teams

Many requirements traceability processes are highly manual and disconnected:

  • For example, Team Member A creates a traceability matrix in Microsoft Excel. This matrix is a table containing artifacts like requirements, test cases, test runs, and identified issues. Its purpose is to show that compliance requirements for a project are being met.
  • However, the artifacts in it get frequently updated during the course of development and testing. So Team Member A goes back in periodically to update the traceability matrix and make sure it is fully up-to-date. This is time-consuming and error-prone work.
  • Team Member B then has to dig through this matrix to see if the changes are relevant to them. It’s possible that what they see at any given point isn’t accurate, though. Keeping up with changes is its own job, with many back-and-forth email barrages to navigate.

Real-time communications within a traceability solution alleviate these issues. Instead of hopping between static documents scattered across emails, team members can collaborate in one virtual space, in which they can share feedback, participate in livestream discussions, see connections between items and their authors or editors, and expedite reviews and approvals. They also have access to all comments, test cases, and activity streams from the same interface.

Such features ensure that changes are communicated directly to the relevant parties and that software traceability stays on track. Team members do not have to waste time poring over a document that might not be 100% accurate or even applicable to their particular responsibilities. Basically, real-time communications remove the traditional bottlenecks of hunting for the latest updates and wondering about their relevance.

2. Chart the Impact of a Change Before it Happens

As noted above, requirements change all the time during software development. It is essential not only to keep team members in sync about these changes, but also to scope out their full impact across the product development lifecycle.

Altering one requirement will directly affect any related system requirements, along with downstream requirements and numerous verification tests. Teams need insight into what these changes will entail, so that they can see if related items are still correct, make any necessary updates, and ultimately trace the right requirements for quality and compliance purposes.

Live traceability in Jama Connect allows for better impact analysis and more streamlined navigation of upstream and downstream relationships:

  • For instance, links downstream from modified items are automatically flagged as “suspect” to alert team members to the need for possible action.
  • Relevant contributors can also be notified right away, and critical decisions prioritized; meanwhile, everyone else can save time by not being pulled into something irrelevant.
  • System users can see if a requirement has test cases downstream and what percentage of them have passed.
  • With all risks and requirements being updated in real time, teams can reliably trace them and conduct informed evaluations and analyses.

Through these capabilities, a traceability solution helps everyone be more confident that they are working with the right requirements, while avoiding getting bogged down in rework or in costly late-stage changes caused by not having an accurate picture of what is being worked on at every stage. In other words: Live traceability means that traceability is no longer an afterthought.

3. Create a Detailed Audit Trail With Well-Documented Changes

One of the main reasons for implementing traceability software is to simplify regulatory compliance. Let’s say that a hypothetical medical device manufacturer is planning to bring a new connected device to the U.S. market.

The Food and Drug Administration requires compliance with regulations such as FDA 21 CFR Part 11, regarding electronic records and e-signatures. Creating a detailed audit trail to comply with these rules is more straightforward if a unified system of record with full version histories – i.e., a software traceability solution – is in place. Jama Connect Review Center is compliant with FDA 21 CFR Part 11.

Modern traceability software maps out the relationships and interdependencies in product development, allowing for assiduous tracking of risks and requirements in their full historical context. Real-time collaboration also enables even geographically distributed teams to stay on the same page in tracking and tracing work items. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as medical devices become more complex and software-driven.

In Jama Connect, risk analyses and other data such as product-specific views can also be easily exported to the correct formats to prove compliance. Industry-standard templates are available as well to minimize the setup time for creating a plan that aligns with standards such as ISO 14971:2019, ISO 13485, and FDA 21 CFR 820.30.

4. Connect Everyone and Everything with Trace Relationships

Traceability is about relationships. Because each product in development has its own particular set of customers, stakeholders, and internal team members associated with it, traceability is only possible if these individuals can be accurately connected to the items for which they are responsible.

That principle sounds simple enough on paper, but putting it into practice can be more complicated. Consider the question of who responds when a series of changes occurs and checks to see if everything is still right. With complex products, multiple team members will likely have to weigh in on and then sign off on these changes, a process that presents some big challenges:

  • Decision-makers might not have clear visibility into the impact of changes to requirements, like their ripple effects on downstream or upstream items.
  • High-quality data on requirements-related changes and why they were done might not be readily available and shareable, either.
  • Coordinating the decision-making process itself can be cumbersome, with everyone exchanging documents via email and struggling to get in sync.

 

Fortunately, these obstacles can be overcome with traceability software. By implementing a shared system of record with real-time communications capabilities, organizations can adeptly manage their trace relationships and relieve the various forms of decision pressure outlined above.

5. Make Traceability More Proactive To Ensure Test Coverage

 

Traceability should not be pursued after the fact. Connecting requirements and other items at a relatively late stage is a recipe for trouble, as it can become difficult to gather all the necessary information and put into proper context. Extensive manual work, and the risks that come with it, are also likely to be required in such a reactive workflow.

 

In contrast, proactive traceability done throughout the product development lifecycle helps reduce risk and pave the way for higher-quality products that align with all of their requirements. Automation is key to this proactivity. Traceability software like Jama Connect automatically saves user inputs, can apply risk level updates in real time in accordance with a user-defined risk matrix, and ensures a standardized approach to risk evaluation across the organization – eliminating silos and disjointed processes.

A traceability solution also provides clear visual representations of the status of requirements, test cases, and test runs along the way. These data-rich views enable better decision-making, since team members are working with live, easy-to-understand information and can communicate with each other through the same platform. For example, users can easily see test coverage levels and where gaps exist.

Take the Next Steps With Traceability Software

The right traceability software lets organizations efficiently manage all of your requirements in one place and streamline the development process of even the most complex products. It saves the entire team time and money, accelerates development lifecycles, reduces the risk of error, and results in improved product quality and regulatory compliance.

In short, traceability provides essential context and clarity. Look for a modern traceability solution that will keep projects on schedule, on budget, and within scope, thanks to better collaboration and requirements management.

As medical device developers compete to push the boundaries on designing and building innovative, connected medical devices, the market continues to boom. It doesn’t look to be slowing down anytime soon, either. KPMG estimates that global annual sales of medical devices will rise by over 5 percent a year to reach nearly $800 billion by 2030.

Modern medical device makers are hyper focused on building innovative, connected solutions for the next generation of care. That continued innovation opens the door for new, lower cost technologies for early intervention and at-home care. But it also opens the door for more risk.

In the past, medical device software was generally used to control programs to simply switch the equipment on and off and display readings. Today, software and its functions dominate much of the features, making devices far more integrated, complex, and connected-and growing more so every year.

Growing Concern for the Security of Connected Medical Devices

While smart devices provide opportunities for instantaneous results and early medical intervention, connected medical devices are also more vulnerable to both deliberate attacks and undirected malware.

A survey released in October 2018 of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18 percent of provider organizations had connected medical devices impacted by malware or ransomware in the last 18 months.

The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

Read this case study to see how RBC Medical Innovations leveraged Jama Connect to unify processes and enhance traceability.

Modernizing Requirements Management to Reduce Risk

The reliance on connected medical devices isn’t going to ebb, and the increased complexity will only make the management and reporting of interconnected information across product definition and verification more difficult and inefficient. This inefficiency is only exacerbated by the use of document-based requirements management, which introduces more risk into the process.

To achieve better results with projects of mounting complexity, teams must get a stronger handle on their process and avoid gaps in development. A better solution for requirements traceability can do just that.

Traceability, normally a sub-discipline of requirements management, ensures that engineering design aligns with the identified needs of users and patients; manages scope by ensuring alignment between engineering work and actual user needs; confirms that device needs are addressed at all levels through gap analysis; and connects the design of the device directly to the verification.

Requirements Traceability is No Longer Optional

Small teams building simple products may be able to get by initially with spreadsheets, documents, and emails, but with the rise of software-driven, connected medical devices and increasing system complexity, requirements traceability quickly becomes too convoluted to be handled manually.

The reality is that the more complicated or distributed the product development process becomes, the more opportunities for error are introduced. Excel just can’t account for the wide array of risks and requirements involved in medical device development.

In fact, according to Stericycle’s Recall Index, software issues were consistently one of the top causes of medical device recalls through 2017 and 2018.

Learn how Jama can help you better manage risk with ISO 14971 by downloading our white paper.

Today’s medical devices are so much more than metal and plastic – they’re incredibly complex, connected devices that require complete hardware and software traceability.

Medical device development contains too many scope changes, remote team members and reviewers, and requirements to be easily managed in documents and emails. Using Excel or an internally developed requirements management solution or system diverts scarce resources and availability away from the important tasks of product development. Instead, team members have to focus on attempting to assemble and maintain traceability, usually resulting in the trace being hastily thrown together in the end for the design history file (DHF).

Traceability increases efficiency, drives alignment, and mitigates organizational risk. And with Jama Connect, teams can link and decompose high-level requirements to more detailed system and sub-system requirements, including associated risks and hazards, to ensure proper verification and validation before release.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.

If you’re responsible for the requirements traceability of your complex product, do any of these scenarios sound familiar?

Scenario One: You just heard that a critical business requirement needs to change and be accounted for in the upcoming release. You need to know how this change will impact work downstream and how the system specification your engineers are working with will change. Immediately.

Scenario Two: Your QA team just found a critical bug in your most anticipated new feature and you’re two weeks away from launch. Do you ship with the known bug and hope to patch it later, or delay the launch? Will this impact your upcoming audit? You need to know who is working on this feature, who else needs to be notified and weigh in on the decision and know what other aspects of the product may be impacted. Immediately.

These scenarios, and countless others like them, affect engineering teams every day. And as software, embedded systems and external sensors contribute to product complexity (not to mention the complications that arise when you’re trying to unify multiple teams that contribute to a product) there is no chance that manual processes and static documentation can scale to support accurate impact analysis and quick decision-making. Requirements may be recorded, but if they’re not in a system of action, in situations like those above, you cannot effectively manage.

Gartner highlights one of the main reasons why companies struggle to achieve the benefits of traceability:

“The most widely adopted tools for requirements continue to be general document software such as Microsoft Office or Google Docs (40% to 50% of the market) due to cost, availability and familiarity. Yet these often lead to poorly managed requirements, thus eliminating and exceeding any cost benefit the tools themselves have. Requirements end up captured in a variety of documents and spreadsheets supplemented by post-it notes in unmanaged versions with no traceability or reuse. This creates a more costly user acceptance testing cycle, both in the time to execute as well as remediation of issues found late in the process, where they are far more costly to address.”

Read more about the Gartner Market Guide for Software Requirements Definition and Management Solutions.

Software and hardware teams must work together in tight collaboration throughout the development process to define market requirements, functional requirements, test cases and other artifacts that define the scope of what you’re building are related in some fashion, either directly or indirectly. This becomes difficult when the teams use different tools and terminology, and work in different cadences with difference methodologies.

Adopting these four best practices around modern requirements management and requirements traceability will help your team ensure product quality, decrease time-to-market, and achieve regulatory compliance.

Four Best Practices for Requirements Traceability

 

1. Connect stakeholders and contributors to the requirements they care about to ensure the right people can weigh in on important decisions at the right time.

Traceable relationships are as much about connecting the people as they are about connecting the requirements themselves. Each requirement in the system has members of the team associated with it — analysts, architects, development, verification and quality assurance among them — and stakeholders and customers who care about its status. With connected relationships built into your project you can quickly get interested parties involved in decision making.

2. Automate bi-directional requirements traceability to minimize risk and ensure quality.

Manually updating an old-style traceability matrix is not only cumbersome and time consuming, it leaves open the risk for human error. In the development of safety-critical products like medical devices and airplanes, this risk isn’t acceptable. And it’s difficult to prove to an auditor that you got it right.

Key to managing requirements traceability is the ability to view source requirements and their related items downstream to lower-level requirements and then back to the source, and know the status of those items at each step of the product development process. Because this data may be stored in multiple systems, it’s key to be able to connect tools via open APIs and automatically pull data into a single actionable system with visualized coverage of these trace relationships.

Learn more about the limitations of a document-based requirements management approach, and how to get the most out of your requirements management by downloading our whitepaper.

3. Connect data, conversations, and decisions in a single system in the product development process.

Being able to visualize coverage of trace relationships is imperative. But what happens when you find a gap, or a test is failing? The ability to confer and collaborate with the people connected to the requirement right in the system allows you to capture decisions and actions and keep that information associated with the requirement. Down the road, if you need to revisit decisions, all data is stored and easy to find.

With this information managers can, for example, verify that their requirements are connected to downstream test cases and see what percentage of those tests have passed. In a system of action, every test case has a comment and activity stream accessible to all users. Testers and contributors can capture decisions, answer questions, and resolve issues transparently and responsively.

4. Conduct formal reviews in compliance with internal controls or industry regulations with built-in reporting.

In the case of proving compliance with a set of rules and regulations, you need to show your requirements, their traceable connections to test plans, and verification that all test have passed. Using a requirements management solution that has built-in formal reviews and reporting for auditors makes this process less cumbersome and more reliable.

Teams facing increasing complexity and pressure to comply with industry regulations must be able to search, track, and connect interdependent requirements. Achieving a faster time to market demands that teams collaborate quickly and effectively while they work on traceable requirements.

To learn more about traceability best practices, download our whitepaper, “Better Product Development: 5 Tips for Traceability”

When our customers move from managing requirements in isolated documents to using a collaborative requirements management solution, they’re better-equipped to conduct impact analysis and ensure full test coverage and traceability throughout the development process.

Managing complex requirements necessitates that information be visible and accessible to all team members at all times. You also have to make sure that all this information is connected in a way that is relevant and comprehensible to your teams. This helps ensure that you’re building what you set out to build, that it fulfills your customers’ expectations, and that it’s safe and compliant.

In order to get a full picture of what’s been built and if it’s on track, it’s crucial to build connections between data, as well as to map the conversations and decisions associated with each requirement.

In this post, we’ll explore how some of our customers have realized these results using Jama Connect™.

Traceability is Essential to Requirements Management

With everything you’re managing day-to-day, the last thing you need is a tool that takes just as much time and effort to learn and use as writing and managing the requirements themselves. A requirements management solution should make your life easier, and it should be easy to roll out to your team. Moreover, the solution should help you step back and look at your entire product or system as it’s being built, see all of the connections, and easily identify where work is needed.

Our Jama Professional Services consultants often hear from customers facing the inherent challenges of complex systems that establishing and managing traceability in Jama Connect is much easier than in any other solution they’ve tried.

Here are five ways to create relationships, account for full test coverage, and manage traceability throughout the development process in Jama Connect

1. Build a framework for properly linking artifacts with relationship rules

Creating meaningful connections between artifacts is vital to having that all-important big picture view. With relationship rules, you specify the proper relationships and how to implement them, while also freeing up your team’s time to focus on building and managing requirements.

2. Find out who is connected to an item and easily communicate with connected users in the Collaboration Stream

Let’s say you notice that something is wrong with the way a requirement is written, and it needs to be adjusted. Jama makes it easy to identify not only everyone who is involved with that requirement, but also everyone involved with impacted requirements. Using the Collaboration Stream, you can quickly post the issue for these connected users, who then receive a notification and can respond quickly —without anyone needing to book a conference room.

3. Determine gaps in your test coverage quickly and easily with Trace View

A critical piece of assuring quality is being able to see where gaps lie in your test coverage. Jama Connect’s Trace View identifies those gaps by leveraging the relationships your team has created to give you a holistic view of where work is still needed.

4. Identify high-level impact across your project using suspect links

If a system-level requirement changes, it could dramatically impact the quality of your product. By using the suspect links feature in Jama Connect, you can see at a glance what other items are impacted by changes and quickly assess whether additional changes need to be made downstream.

5. Understand how product features are connected or share IP using Reuse and Sync

Complex systems make for complicated connections between individual systems and products. Jama Connect allows you to share crucial pieces of information across product lines, compare these connections at a glance, and align them with the click of a button using the Reuse and Sync feature.

Managing traceability in complex product and systems development is challenging, but it’s essential for ensuring product quality, on-time and on-budget delivery, and alignment between customer expectations and the final deliverable. That’s why you need the right product development platform to help you achieve traceability and reap the benefits.

For more strategies for establishing traceability in product development, download the whitepaper “Better Product Development: 5 Tips for Traceability.”

 

The popularity of Agile methodology, along with the increasing trend toward automation in software development, has pushed requirements management solutions to evolve. The misconception that Agile methodology doesn’t work in regulated industries is outdated, but regulated industries have, justifiably enough, specific expectations of their requirements management (RM) solutions, and those expectations continue to drive change in the market.

A recent report from Forrester Research, “Now Tech: Agile Requirements Management Tools, Q2 2018,” outlines the state of the market for Agile RM solutions and lays out the questions customers should ask when selecting the right requirements solution for their space.

Why invest in requirements management?

According to Forrester, it’s not just highly regulated industries and organizations involved in complex product development that can benefit from a requirements solution.

In spite of the “a coalition of Agile aficionados arguing that it’s unnecessary to formally collect and manage requirements,” the report suggests that best-in-class RM solutions can significantly improve product design and delivery for Agile development teams: “In the face of increasing regulations, connected products for the internet of things (IoT), and scaling Agile practices, AD&D [application development and delivery] leaders long for something to bring traceability and auditability to their processes without sacrificing speed.”

Why do you need traceability?

The right RM solution enhances development transparency through traceability. Traceability is a roadmap that shows you where in the product development lifecycle each requirement or business rule was implemented. With traceability, teams are better-equipped to perform impact analysis – i.e., to assess the consequences of proposed changes. This is crucial in complex product development, where simple changes can have far-reaching impacts, and it’s tough to isolate every system component that might be affected by a change in requirements.

Teams facing increasing complexity, pressure to comply with industry regulations, and the need to measure customer value must be able to search, track, and connect interdependent requirements. Achieving a faster time to market demands that teams collaborate quickly and effectively while they work on building out traceable requirements and test cases.

Why is it important to reduce tech debt?

Forrester reports that RM solutions can also help Agile teams reduce technical debt. Agile teams are focused on moving quickly, so they sometimes fall back on fixes that are easy to implement right now, but that will require rework down the line. Basically, tech debt refers to the work you’ll have to do tomorrow because you cut corners today.

You can’t avoid tech debt entirely, and you shouldn’t even try; you can’t move quickly without accumulating a little. But as the Agile methodology becomes even more widespread and project complexity continues to grow, RM tools will help development teams understand what has been done, what will be affected in the next sprint, and how to improve collaboration within distributed teams.

Finally, the report suggests, development teams can use RM solutions to embed visual modeling, design, and prototyping into their product development process. By modeling customer journeys, business processes, system designs, and user-interface components, teams can ensure that the final deliverable meets stakeholder expectations.

How has Agile changed requirements management?

Agile teams expect to move fast, so RM solutions looking to penetrate this market must meet developers’ need for speed. Transparency is another priority for Agile teams, and the transparency and traceability offered by an RM platform empowers teams to move beyond what the report dubs “static, text-based requirements.” As we noted above, traceability enables more effective and timely impact analysis, a critical consideration for rapidly evolving requirements.

Even though plenty of Agile teams see the value of a requirements solution, Forrester notes that “vendors have shied away from the term [requirements management] and evolved their offerings to fit new product niches.” Part of this avoidance of the term is because people tend to associate “requirements management” with clunky, tedious processes that lacked the efficiency and ease of use that current solutions offer. In contrast, the requirements solutions favored by Agile teams are less highly specialized; they have different capabilities and focus on different segments of the development lifecycle. As such, the Forrester report suggests that Agile teams consider whether the best solution for them is not one solution but a combination.

How do you choose the right requirements solution?

To maximize success in requirements management, the report found, teams should choose a platform that works for their discipline (product management, engineering) and their industry (medical, automotive).

As we wrote in our recent post, “Systems Thinking for Complex Product Development,” collaboration is easier and delivers better results when teams are encouraged to find approaches that are effective for them within their disciplines.

Before investing in a RM solution, Forrester suggests that Agile leaders engage in some strategic thinking to determine which RM platform will deliver the most value in concert with other tools and solutions. Decision-makers should:

  • Audit the tools already in use. Company and industry requirements drive investment, so understanding the existing ecosystem of tools already in place at your organization is essential in choosing the best RM solution for your particular needs. Take a close look at your Agile planning/project management, design, testing, and continuous integration tools to determine the best solution for your organization.
  • Identify where requirements fall apart. If you have issues uncovering requirements to begin with, consider a tool with more advanced collaboration, design, and modeling capabilities to help you define exactly what you want to build. If your challenge is understanding the impact of requirements, passing tests, or avoiding bugs in production, you need a tool with greater traceability and robust reporting capabilities that can integrate with automated testing tools.
  • Anticipate change. What changes are ahead for your industry? How will you be affected by new or evolving government regulations? Will your products be integrated with sensitive customer information? Now is the time to start laying the foundations for compliance with these future requirements.
  • Right-size the need for documentation. What’s the future of Agile at your organization? Are you looking to scale Agile companywide? Even if you don’t need a super-robust RM solution now, you’ll need to implement some governance early unless you want to be drowning in technical debt.

To learn more about how Jama Connect® stacks up against other requirements solutions, download our eBook, “Selecting the Right Product Development Platform.”