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Requirements Traceability – Does My Data Model Matter?

Nearly all engineering organizations have one or more initiatives underway to improve their product development process. Live Traceability™, Model-Based Systems Engineering (MBSE), and digital engineering are the most common areas of focus. As engineers look over the fence and make fun of marketing types for being distracted by shiny objects, marketeers look back and see a similar behavior – just with geekier objects like SysML, digital twins, and simulation. The recurring pattern we see is that at some point during the early stages of the initiative, the realization hits that the data model for requirements across teams and projects is highly inconsistent and lacks consistent relationship rules among data objects. It becomes clear at this point that further progress on the initiatives cannot be made without first fixing the inconsistent and lacking data model.

Some teams will resist an effort to establish a consistent core data model. These teams will ask to keep the flexibility to refine their own engineering data shape and that is OK. The keyword is “refine” and not “define.” Having a consistent core data model, that some teams are allowed to refine for themselves, allows for innovation around the engineering process while still enabling process-wide, integration automation, Live Traceability, model-based systems engineering (MBSE), and digital engineering.

Current Requirements Data Model

For most companies, the data model mess came into existence through a project- and document-centric mindset with legacy requirements management tools. Each project team was allowed to modify their own data structures and each set of requirements lived alone as a document in a repository. This provided project teams with flexibility but over time and over dozens, hundreds, or thousands of projects has led to a challenging situation. We often find that teams have defined the same information in numerous different ways and that even within the same teams there is significant variance across documents. In short, the best way to describe the situation is as a repository of thousands of self-contained documents and no data model exists nor even a common definition of objects upon which to achieve Live Traceability, reuse across projects, MBSE, or digital engineering.

To Get Started With Your Free Data Model Diagnostic™ Consultation: CLICK HERE

Systems Engineers Career Path

Most Systems Engineers we speak with have a common perspective on their role within their organization. Systems engineering as a concept is understood and supported by leadership. And, if systems engineering best practices are followed across all engineering disciplines, leadership also acknowledges the benefits the organization can realize. However, leadership will not force change on engineering disciplines (software, hardware, electrical, risk, verification, and validation) to remove barriers to systems engineering best practice adoption. This leaves most Systems Engineers in the challenging position of possessing responsibility for achieving systems engineering benefits without the authority to ensure engineers adopt best practices.

The good news is that there is a way out of this situation. The first step to elevating your career is to realize that managing the product engineering process through data is the key and that the Systems Engineering role is the natural role to lead this. For most organizations, the product engineering process is the only process in the company that is not managed through data. No one can go to a system and see the status of all product requirements and where development, integration, risk, and testing stand at any point in time. There is no way to manage by exception. There are no alerts that requirements are not covered, test cases are missed or that hardware made a change that now impacts software. Most organizations have come to accept this state of affairs and try to manage the process through endless meetings, emails, and Slack messages.

Until the product engineering process is manageable through data, Systems Engineers will be stuck in their current trap — endlessly trying to address issues after the fact, holding unwanted meetings, and the uphill battle of trying to persuade changes in behavior. Below is a 3-step approach that Systems Engineers we work with have used to solve this organizational challenge and have thereby elevated their careers. As with any process change, it is best to do it in stages. You can start with the following steps.

Baseline current process performance
Build the business case for change to gain support
Deliver quick wins

To Get Started With Your Free Traceability Diagnostic, CLICK HERE

Step Two | Build Business Case for Live Traceability™

Once you have established a baseline, it is now possible to build a business case for change that will resonate with leadership. Based on your baseline, the Traceability Diagnostic determines the probability of negative product outcomes (defects, delays, rework, cost overruns, etc.) and the magnitude of these events. This quantifies the risk of maintaining the status quo and doing nothing. In addition to the risk reduction potential of Live Traceability, the Diagnostic also calculates the engineering productivity gains from eliminating the need for time-consuming, manual, after-the-fact traceability efforts.

Step Three | Start with Quick Wins

Once you have secured support to move forward, it is common to be able to deliver some quick wins to the organization shortly after project kick-off. The typical place to start is the painful and time-consuming after-the-fact traceability efforts. For example, continuous syncing between requirements and software development task management in Jira or Azure DevOps can be set up quickly to automate traceability from requirements to user stories, eliminating a large source of risk and manual, after-the-fact traceability effort. Once quick wins are shown, organizational momentum increases even further and puts you on the success path to begin managing the product engineering process through data.

Clients of ours that have taken this approach have received significant recognition, been promoted into roles with greater leadership, and have increased their external visibility through speaking engagements. Live Traceability is a unique opportunity to elevate one’s career. Don’t miss the chance.

Live Requirements Traceability

Achieving Live Traceability™ of product requirements, as necessitated by industry standards, across siloed engineering teams and tools, is the #1 unsolved problem for most product development organizations. One of the main barriers is that each engineering discipline (systems, software, hardware, electrical, risk, verification and validation) has optimized its own process and tools. When looking at the end-to-end product development process siloed teams, tools, and data make it very challenging to trace development activity from initial requirement definition through development and testing.

As a result, requirements traceability becomes a time-consuming, error-prone, frustrating, and manual, after-the-fact process. The inability for the product development organization to continually trace ongoing development efforts and changes back to user and system requirements results in missed requirements, defects, rework, delays, audit letters, and cost overruns.

How to achieve Live Traceability™ without forcing change on engineering teams

So how does an organization achieve Live Traceability across a best-of-breed tool environment supporting disparate methodologies, terminologies, fields, and statuses? The answer is a 3-step approach:

Step One | Live Traceability Model

Define a Live Traceability model across the end-to-end product development process with relationship rules for the traceable data elements across best-of-breed tools. An automotive functional safety example is shown below. Here you can see the operational instantiation of functional safety standards requirements in a relationship model within Jama Connect®. All necessary traceable information is included with continuous syncs to best-of-breed tools within engineering teams to deliver Live Traceability.

Step Two | Adaptive Data Field Mapping

To achieve Live Traceability, integrations with best-of-breed tools (such as those shown in the example) are required. The typical integration approach standardizes field names and statuses to ensure consistency across the connected tool, but this does not achieve the dual objective of Live Traceability with no changes required in how each engineering team works. Alternately, the proven approach is to apply adaptive data field mapping to ensure no change to engineering teams’ fields and statuses which simultaneously ensures a consistent, process wide, Live Traceability model. This is achieved through robust mapping and normalization logic functionality to easily address the various approaches taken by each engineering team.

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Requirements Traceability – How to Go Live

Requirements traceability is required by many industry standards to ensure product quality and safety. The industry standards are based on decades of progress made in systems and quality engineering research with requirements traceability at the core. Benefits from requirements traceability are achieved if and only if traceability is used as a tool during the product development process. These benefits include greatly reduced or eliminated delays, defects, cost overruns, and rework. Here is an overview of the best practice approach to achieve Live Traceability™.

Live Traceability vs. After-the-fact Traceability

Let’s start with some definitions to make sure we are all on the same page. Requirement traceability is defined as tracking the development progress of product requirements from definition and design through development, testing, verification, and validation. There are two forms of requirement traceability: after-the-fact traceability and Live Traceability.

After-the-fact traceability occurs after the product has been developed and is typically a highly manual effort to try and re-create artifacts to demonstrate traceability that should have occurred during the development process but did not. This effort is undertaken solely for complying with industry standards and satisfying auditor requests for demonstration of process maturity.
Live Traceability occurs in real time as the product development process progresses to improve overall productivity (by ensuring engineers across disciplines are always working off the most recent and correct versions) and to reduce the risk of negative product outcomes (delays, defects, rework, cost overruns, recalls, etc.) through early detection of issues. The benefits of early detection of issues are significant. Research by INCOSE found that issues not found until verification and validation are 40 to 110 times more costly than if found during design. For this reason, most companies want Live Traceability but are stuck with legacy tools and spreadsheets that do not support it. Since each engineering discipline is allowed to choose its own tooling, the result is a large number of tools with no relationship rules or mechanisms to create Live Traceability across them.

So how do you achieve Live Traceability?

Step 1: Define a Traceability Model

Live Traceability requires a model of the key process elements and their relationship rules to monitor during the development process. The systems engineering V Model is a useful framework to start with for data object and relationship definition. Jama Connect® uniquely provides a point and click, configurable, relationship rule capability to enable Live Traceability. Below you see a sample relationship rule diagram from Jama Connect. Relationship rules vary by industry and company-specific requirements. Best practice templates are provided to comply with industry standards and configured to meet client-specific needs. The definition of a traceability model forms the foundation for model-based systems engineering since it defines model elements and their relationship to each other in a consistent manner across the entire system architecture.

Step 2: Setup Continuous Sync for Siloed Tools/Spreadsheets

Once the relationship rules are defined, the next step is to set up continuous sync with best-of-breed tools and spreadsheets used by the various engineering disciplines. The traceability diagram below shows a typical example of best-of-breed tools and where they sync in the Jama Connect relationship model to deliver Live Traceability.

Most companies prioritize the areas of the traceability model that are most prone to lead to costly issues in the absence of a continuous sync. Most commonly, these areas are:

Software task management – directly linking the decomposition of requirements into user stories enables Live Traceability through the software development process through testing and defect management. The most common best-of-breed tools used are Jira and Azure Dev Ops.
Test automation – test cases are managed in Jama Connect to align to requirements and ensure traceability across all engineering disciplines with the test automation results sync’d to the traceability model at the verification step. The most common test automation tools are TestRail and qTest.
Risk analysis (DFMEA/FMEA) – is most often conducted in multiple Microsoft Excel spreadsheets and the assumption has been that Live Traceability was not possible with Excel. Jama Connect is the first requirements management solution to enable Live Traceability with Excel functions and spreadsheets. Risk teams can now work in their preferred spreadsheets AND for the first time achieve live traceability to stay in sync with changes made by any engineering team. Ansys Medini is also a supported integration.
Model-based systems engineering (MBSE) – the first step in MBSE is to define a relationship model between all product requirements. Once a relationship model is defined, then specifications can be determined through modeling. Jama Connect uniquely provides model-based requirements to sync logically with a SysML modeling tool like Cameo No Magic. Other requirements management tools do not ensure a model-based approach, which most often leads to inconsistent and conflicting fields across teams and projects and provides no coherent relationship model.

Step 3: Monitor for Exceptions

Live Traceability provides the ability, for the first time, to manage by exception the end-to-end product development process across all engineering disciplines. The traceability model defines expected process behavior that can be compared to actual activity to generate exceptions. These exceptions are the early warning indicators of issues that most often lead to delays, cost overruns, rework, defects, and recalls. Below is a sample exception management dashboard in Jama Connect.

Benefits of Live Traceability

The main benefits of Live Traceability across best-of-breed tools are as follows:

Reduce the risk of delays, cost overruns, rework, defects, and recalls with early detection of issues through exception management and save 40 to 110 times the cost of issues identified late in the process.
Comply with industry standards with no after-the-fact manual effort.
No disruption to engineering teams that continue working in their chosen best-of-breed tools with no need to change tools, fields, values or processes.
Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments.

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2022 Engineering Predictions: Overcoming Three Key Industry Challenges

In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will offer unique challenges, opportunities, and more than likely, many surprises.

As we enter a new year of further changes, Jama Software asked select thought leaders – both internal and external – across various industries for the trends and events they foresee unfolding over the next year and beyond.

In the first part of our five-part series, we ask Josh Turpen, Chief Product Officer at Jama Software, to weigh in on product and systems development trends he’s anticipating for engineering teams in 2022.

Read our other 2022 Industry Predictions here: Part Two – Medical Device Predictions, Part Three – Automotive Predictions, Part Four – Aerospace & Defense Predictions, and Part Five – Insurance Development Market Predictions.

Engineering Predictions

Design Trends

Q: What product, systems, and software development trends are you expecting to take shape in 2022?

Josh Turpen: Complexity will continue to increase and supply chain challenges will be a multiplier. The “chip shortage” is a great example. There aren’t too few chips, there are too few of the chips that OEMs are used to. Adaptable OEMs, with advanced product management and traceability, have been able to overcome this challenge.

Q: In terms of product and systems development, what do you think will remain the same over the next decade? What will change?

Josh Turpen: Software will continue to outpace hardware development, but hardware will close the gap. Connected tooling, simulation, and a transition to collaborative, JIT processes will enable hardware engineers to ditch the “one big meeting” for a more natural, asynchronous communication flow.

Q: How do you foresee regulations shifting in product and systems development for engineering teams over the next decade?

Josh Turpen: I still think my previous prediction (2021 Predictions) is accurate. Regulations are coming for software in a big way. This is the tip of the iceberg.

RELATED: G2 Names Jama Connect® the Leader in Requirements Management Software

And of course, you do not do that in your own ecosystem. You have many, many connections around you that have input on those decisions and have input on those connections, so engineering partners, customers, other departments within the company can be invited to take part in that process. We’ll take a look at that a little bit later on.

So, in the Jama Connect solution, we will take a look at the first part for data to information, so how do we actually relate information together and what is involved in building those relationships. And when I have them, what leverage, what value can and benefits can I get out of those relationships and what kind of overview do they give me? Now then, on the question part, we’ll take a little look as well on all the different areas where Jama Connect allows you to collaborate and to capture decisions and information on the changes you make during the process of building up your requirement.

Why would we do all these exercises in the system? What is the underlying question? There’s a number of questions we get on a daily basis from our customers when it comes to traceability, so questions like, did we miss anything? Are we building a product that is still complying to what we originally set out to do? What was the original requirement? Where do we start off from? Do we have everything covered when it comes to the validation or the actual testing of parts? The embracing change is something that a lot of customers are on different levels when it comes to how they approach change, but when you look at change, and actually before you do the change, you can see what will happen if you do change that item and what will happen if you start editing the information you have at the top level or at a medium level, it gives you a lot more insight into what will happen and what will the impact be for the organization. So, change becomes a bit more, let’s say, easier to look at and to decide what you want to do.

Then lastly, the validation part is one I highlighted. When I have all these items and places, information and plans, how can I go back and say, “Okay, I have everything validated. I have everything verified. I’m compliant to standards internally or external standards or processes that we set out to comply to.”

Watch the full webinar to learn more about best practices for requirements traceability.

Product complexity is growing at an exponential rate. As it does, requirements move between more and more departments and stakeholders throughout the course of the development process. Requirements traceability helps product teams overcome one of the biggest challenges they face with requirements management.

The number of decision points is higher than it’s ever been. Each decision needs to be made understanding the impact on the requirement itself and on the product overall. It is essential to maintain visibility into the activity taking place and to be able to tie it all together.

That’s where requirements traceability comes in. What follows is a look at the definition of requirements traceability, as well as its purpose, importance, and benefits. You’ll also find common challenges of requirements traceability, along with a few ideas to help you start overcoming those obstacles today.

What is requirements traceability?

Requirements traceability is the tracking of requirements throughout the product development lifecycle. It is a documented thread that provides forward and backward visibility into all activity surrounding each requirement (including design, development, testing, and support). Requirements traceability helps minimize the risk of negative outcomes and maximize productivity. Its benefits include greater team efficiency, easier regulatory compliance, and higher-quality products.

The purpose and importance of requirements traceability

Requirements traceability enables product teams to associate a specific requirement with all the related project artifacts, as well as other requirements, both forward and backward, so that anyone can see how the activity relates to the requirement—and vice versa—at any point during development. This functionality, also called live traceability, fosters team collaboration and enables early detection of possible production risks.

Think of it this way: How important is it to have your products developed correctly in terms of definition, quality, and timing? Mission critical, right? That’s why requirements traceability is so critical.

Let’s take a look at some of the benefits of requirements traceability throughout the product development lifecycle. For example, live traceability:

Simplifies project estimates
Enhances process visibility
Increases development efficiency
Improves impact analysis of change
Demonstrates verification and validation
Strengthens product quality
Proves compliance or functional safety

A single line of sight on a requirement, or a digital thread, is supremely important for application lifecycle management (ALM) and product lifecycle management (PLM). Both endure tight timelines and increasing numbers of requirements — including those from regulations, where compliance is non-negotiable.

Knowing the relationship between requirements, risk, tests, and so forth, is the difference between developing a compliant product on time and getting stuck in rework, delaying launches, and dealing with unhappy stakeholders. With requirements traceability, you don’t have to compromise on speed or quality.

The bottom line is that end-to-end traceability confirms you’re building the right thing and helps you prove compliance or functional safety. Without requirements traceability your development efficiency and product quality are in jeopardy.

Forward and backward traceability: The mechanics of creating a digital thread

To connect all the phases of the product development lifecycle, from customer needs through support, four distinct kinds of links must be used to thread the process end-to-end. This includes high-level requirements as well as derived requirements—those not specifically defined but necessary for meeting defined requirements or having the system work as expected. Derived requirements must also be adequately traced to reap the full benefits of live traceability.

What is forward traceability?

There are two kinds of forward traceability: forward to requirements and forward from requirements. They both trace from an upstream component to downstream artifacts. The difference is in where they begin.

Forward to requirements traces from customer need to requirements. This is important because customer needs can evolve over time. If they do, requirements may need to change as a result. Following this type of forward traceability enables teams to be informed of changes in priorities at any time throughout development.

Forward from requirements traces relationships between requirements and corresponding downstream artifacts, including test cases. This type of trace ensures that each requirement is not only satisfied but verified and validated.

What is backward traceability?

Like forward traceability, there are two kinds of backward traceability. This pair traces from an endpoint, or downstream work product, to upstream elements. The two types of backward traceability have differing starting points.

Backward from requirements gives insight on how a requirement came to be by linking the requirement to the customer use case it addresses. This enables teams to improve decision making by understanding the origin of a requirement.

Backward to requirements begins at performed work and traces to its requirement. It gives visibility into why specific items were created and how different pieces of a system fit together. Tracing in this way also allows testers to find gaps or missing requirements.

What is bidirectional traceability?

Bidirectional requirements traceability is the ability to perform both forward and backward traceability. Bidirectional traceability is the optimal type of traceability because it gives teams full visibility from requirements specifications through building, testing, changes, defects, and back again. Traceability of this caliber can only be achieved through automated requirements management tools, such as Jama Connect®.

Common challenges of requirements traceability

If all this sounds like traceability is too difficult, fear not. While there are some challenges to requirements traceability, there are also many templates and tools you can use to streamline the process (more on that below). For now, let’s tackle some of the challenges so you can see how they can be overcome.

Differing organizational viewpoints.

Not everyone has the same understanding of why and how traceability should be performed. Stakeholders in sponsor or management positions may only view requirements traceability from a standard or regulatory perspective. They see it as a “must-have” but may not understand the additional benefits of requirements traceability (as discussed above) in the way a project or systems engineer might.

One way to tackle this obstacle is to educate stakeholders on what can be achieved if end-to-end traceability is achieved. Share this article with everyone involved in your development process so they can have a basic understanding of why requirements traceability is an essential part of requirements management, beyond simply knowing they need it to cover their bases.

Organization-wide adoption.

There are a variety of reasons a company might be slow to adopt traceability. Training is one such example. As considered regarding stakeholders, not all teams or individuals working on a project know why traceability is so crucial, or they simply may not know how to execute proper traceability correctly. Additionally, some people may be worried that traceability data from their decision points could come back to bite them.

If this is a challenge for your organization, again, education is imperative. But even beyond that, you need to create a culture in which traceability is seen as an inherent part of the development process. Start by creating clear policies regarding how the organization manages traceability. Then develop a positive training program for all new and existing employees to complete. If you choose a requirements management tool, make sure it has a strong track record of being intuitive and easy to use software that adapts to your process—not the other way around.

Want the inside scoop? See what users are saying about Jama Connect

Cost of implementation.

Getting an entire development organization on the same page regarding requirements traceability, then ensuring proper execution, can be a costly endeavor. The time spent developing policies, conducting training, and creating/maintaining traceability data add up and can even make folks feel less productive. Additionally, you may choose to adopt a traceability tool to streamline your process, which means upfront costs will be higher than previous projects.

Overcoming this obstacle requires a mindset change. We urge you to consider the cost of doing nothing. Unproductive work time, lengthy time-to-market, rework, and defects are all extremely expensive symptoms of inadequate requirements traceability. Each of these carries a hefty price tag. For a look at exactly how much these complications could be costing your organization, check out the calculators on pages 9-11 in our Buyer’s Guide. While there are costs to implementing requirements traceability and management tools, the amount saved throughout the development process far outweighs the short-term investment.

Managing change.

When building complex products, change is inevitable. It is essential that team members know about the changes and scope their impact across the product development lifecycle. That means looking closely at any related system requirements, downstream requirements, and verification tests that may be affected.

Performing this activity can be cumbersome and time consuming with manual requirements traceability tools. And the associated risks are similar to doing nothing, simply because you cannot be sure you’ve accounted for everything when dealing with static documents and human error.

If you’ve experienced this setback in your organization, it may be time to explore automated requirements management tools that enable live traceability with living requirements.

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!

Improper management tools.

Some development teams are still tracing requirement relationships using Word or Excel documents and collaborating via email. A Requirements Traceability Matrix is one example of a document that manually traces elements of requirements management including, business requirements, objectives, design elements, and test cases via a spreadsheet. Teams input the list of requirements and fill in the related data. The spreadsheet is static but is updated manually by the team throughout the development lifecycle.

There can be advantages to using a Requirements Traceability Matrix if you are developing a product that doesn’t have many requirements. And it is better than not tracing at all. You can even use a template to create a Requirements Traceability Matrix. However, if your product is complex, with many requirements, you’ll likely experience many of the challenges discussed above.

In the case of complex products, a Requirements Traceability Matrix does not have the functionality you’ll need to keep up with the pace of change and create a quality product in the timeframe required by stakeholders. Flexible requirements management tools like Jama Connect can even capture trace relationships across teams and toolsets, further enhancing the benefits of traceability.

Insufficient compliance framework.

Regulated industries need requirements management to demonstrate compliance with industry standards. There are specific ways reviewers and regulators must receive regulatory submissions. To pass an audit you must present proof of comprehensive traceability.

If comprehensive traceability wasn’t performed throughout your development process, a lot of time will be committed to gathering the necessary information after the fact. Even if traceability was meticulously maintained in Word or Excel, there will still be time spent compiling it into an acceptable format for regulatory submission. In the meantime, competitors that make traceability inherent to their process will be first to market.

Sound familiar? Luckily, there are tools that perform end-to-end traceability and come with frameworks aligned with industry standards. Requirements management tools like Jama Connect simplify the audit process with export templates, thus speeding up the compliance presentation process.

Templates and tools to streamline the requirements traceability process

There are numerous tools available to assist with the requirements traceability process. It’s important to assess your needs to know what is best for you.

Are you creating a straightforward product that doesn’t have functional safety or regulatory requirements? If so, a Requirements Traceability Matrix may suffice. Download this Requirements Traceability Matrix template to get started today.

Are you creating a multifaceted product with both software and hardware components? Will you be required to prove functional safety or regulatory compliance? In these cases, you’ll need a requirements management tool with bidirectional traceability and compliance templates you can easily export.

Here’s some additional recommended content on traceability you might find helpful:

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

Audit trails are integral to regulatory compliance in industries ranging from medical device manufacturing to automotive production. But what’s the best way to build an audit trail that stands up to scrutiny?

Building a solid audit trail all starts with live traceability.

Why Live Traceability™ is Necessary

Live 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.

In 2019, there were 50 medical devices recalled by the FDA — the most since 2014. Among other purposes, an audit trail helps strengthen product development controls and in turn curb the risk of recalls.

The top three reasons for recalls throughout the 2010s were device design flaws, software issues, and defective production processes. Audit trails document how such problems emerged. But too often, audit trails are assembled after the fact, without live traceability. Information may be pulled from numerous discrete documents, such as spreadsheets with hundreds of outdated entries. In contrast, live traceability happens along the way, adding supporting context for data relationships and contributing to better decision-making and future planning.

Live traceability makes it possible to both manage and respond to change in a systematic, auditable, and confidence-enhancing way. In our new infographic, we examine the ways that live traceability allows teams to build an audit trail.

Modern Product Development Requires Live Traceability™

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.

Modern traceability software (like Jama Connect) 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 products become more complex and software-driven.

Download the full infographic to learn more about building an audit trail through live traceability.

SEE FULL INFOGRAPHIC

Tag Archive for: Live Traceability

Requirements Traceability – Does My Data Model Matter?

RELATED READING: Requirements Traceability – How to Go Live

To Get Started With Your Free Data Model Diagnostic™ Consultation: CLICK HERE

READ MORE ON REQUIREMENTS TRACEABILITY

Systems Engineers Career Path

RELATED POST: How to Overcome Organizational Barriers to Live Requirements Traceability

To Get Started With Your Free Traceability Diagnostic, CLICK HERE

Live Requirements Traceability

RECOMMENDED READING: Requirements Traceability: How to Go Live

RECOMMENDED READING: Benefits of End-to-End Traceability

How to achieve Live Traceability™ without forcing change on engineering teams

RECOMMENDED READING: Requirements Management Guide: Requirements Traceability

LEARN MORE

Requirements Traceability – How to Go Live

Live Traceability vs. After-the-fact Traceability

RELATED POST: Requirements Management Guide: Requirements Traceability

So how do you achieve Live Traceability?

Step 1: Define a Traceability Model

Step 2: Setup Continuous Sync for Siloed Tools/Spreadsheets

Step 3: Monitor for Exceptions

Benefits of Live Traceability

LEARN MORE

Engineering Predictions

Design Trends

RELATED POST: How EN 50128 Establishes Functional Safety Standards for Railway Software

Biggest Challenges

Predictions

RELATED: G2 Names Jama Connect® the Leader in Requirements Management Software

What is requirements traceability?

The purpose and importance of requirements traceability

Forward and backward traceability: The mechanics of creating a digital thread

RELATED POST: Building an Audit Trail Through Live Traceability

What is forward traceability?

What is backward traceability?

RELATED POST: Checklist: Selecting a Requirements Management Tool

What is bidirectional traceability?

Common challenges of requirements traceability

Differing organizational viewpoints.

Organization-wide adoption.

Want the inside scoop? See what users are saying about Jama Connect

Cost of implementation.

Managing change.

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

Improper management tools.

Insufficient compliance framework.

RELATED POST: Requirements Management Tools and Software

Templates and tools to streamline the requirements traceability process

Here’s some additional recommended content on traceability you might find helpful:

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

Why Live Traceability™ is Necessary

RELATED POST: What is Requirements Traceability and Why Does it Matter for Product Teams?

Modern Product Development Requires Live Traceability™

Download the full infographic to learn more about building an audit trail through live traceability.