Tag Archive for: Live Traceability

Risk Management

Medical Device Risk Management

Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a reactive way, is not sufficient to create a safe product. Implementing an effectively proactive process and achieving live traceability throughout development, while adhering to the standard will result in a higher quality and safer product fit for market use.

In this blog, I will share how proactive risk management along with Live Traceability™ are two key areas that every medical device developer should focus on when it comes to risk management.

Reactive vs. Proactive

A lot of medical device developers do not prioritize risk evaluation throughout the different design stages, but instead, consider risk a checkbox activity at the end of development. With important prototype deadlines, limited funding, and resource constraints, it’s very easy to make excuses for not running risk evaluations of initial user needs but waiting until entire subsystems have been designed. This may seem like a minor hiccup, but the lack of ongoing risk assessment from an early stage can be very risky for FDA approval, future patients as well as your business’s bottom line and reputation. The later that risk is addressed, the more expensive changes are to incorporate. Delays become the norm as well as budget overruns.

Jama Connect Enables Live Traceability™ Across Your Development Process: Learn more!

Live Traceability™

The number one cause of inspectional observations, product recalls & delays, increased CAPAs, and cost overruns is the lack of live traceability throughout different development stages. With complex medical devices, there can be thousands of user needs, product requirements, risks, mitigating requirements, tests being executed, and defects logged. At Jama Software, we’ve noticed that a lot of medical device developers are using different technologies and applications to store this information including Excel, Jira, Word, and others. The below image depicts that and shows the siloed world a lot of engineering teams are living in:

 

 

Unless you have a real-time system that can interface with spreadsheets, tools like Jira and other applications, it’s impossible to get a holistic view of development. This can cause several issues, some of the most critical being:

  • Late identification of defects/coverage gaps due to lack of visibility throughout the development process​
  • Lack of requirement coordination and change management between hardware/software​
  • Lack of ongoing risk assessment and change management​
  • Cumbersome and risky effort to produce trace reports and other DHF artifacts

RELATED POST: Avoid the Most Common Challenges of the Design History File

Without Live Traceability, risk teams can’t be effective in mitigating potential failures or hazards. Outdated and manually updated trace reports and spreadsheets can’t be relied upon. What if there was a way to get a real-time view of traceability throughout development?

At Jama Software, we’ve created the capability for our product development platform to integrate seamlessly with tools like Excel, Jira, and others straight out of the box, and we are proud to be the only vendor on the market that can help engineering teams realize Live Traceability. Risk should be a priority, not a checkbox item!

Get in touch with us to see how we can help you.


Requirements Traceability

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.   

RELATED READING: Requirements Traceability – How to Go Live

What is Necessary to Move Forward 

Organizations invest in software tools but have forgotten to invest in their data.  A consistent data model is the best way to maximize the benefits of software tooling, but can only be achieved by spending time on analysis. 

Jama Software has developed a Data Model Diagnostic™ (DMD) to help tackle this challenge, taking data from your legacy tool (IBM® DOORS®), understanding its shape and size, and transitioning the data into a model-based framework (Jama Connect™). The DMD automates the analysis of the existing documents to determine the most common object definitions upon which to base a consistent data model going forward. Once a data model has been determined, the next step is to implement a model-based, requirements management solution that ensures compliance is maintained. As opposed to a legacy, document-centric requirements management tool, a model-based one ensures consistent application of all objects AND defines and maintains the relationship rules among the objects. This forms a model representation of the requirements in a consistent manner across projects and is a necessary requirement for MBSE and SysML modeling.   

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

READ MORE ON REQUIREMENTS TRACEABILITY


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. 

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

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

Step One | Baseline Current Traceability Performance 

The first step towards moving the organization to manage the product engineering process through data is to baseline current process performance.  The best place to focus the baseline effort is on traceability since it spans the entire product development process, is a data management concept that is understood, enables systems engineering benefits, and is required by industry standards. To ease the baselining effort, we’ve developed a Traceability Diagnostic that you can use to assess your current situation. The Diagnostic inventories traceable data, the systems in which they reside, and your current Traceability Score™. This is a few-hour effort and forms the basis of the business case in step two.

In this no-cost, guided process, we’ll help you:

  • Understand the monetary risk of your current Traceability Debt™
  • Uncover the quantifiable ROI of moving to Live Traceability
  • Develop a clear plan of action, cost, and timing to achieve Live Traceability

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. 

RECOMMENDED READING: Requirements Traceability: How to Go Live

No common platform exists 

The typical approach to solve this generic process problem with software is to force every user onto a single platform and follow one common process. This works for standard business processes in HR, Sales, and Finance, but engineering disciplines across systems, software, hardware, electrical, risk, test, verification, and validation each follow different methodologies and use multiple tools including spreadsheets, desktop, and homegrown applications. Each engineering discipline has optimized their own development environment and strongly resist any attempts to change. Engineering leadership defers to each engineering discipline to define how to best do their work and is loath to dictate processes and tools that will negatively impact the performance and morale of each engineering team.  

In addition to the organizational barriers to standardization, no single platform is even close to currently existing which replaces these dozens of tools. A single platform would need to cover all of the following software categories AND address all functionality in spreadsheets (Excel), scripts, desktop, and homegrown tools: Requirements Management, CAD, MBSE, DFMEA/FMEA, software task management, software code management, automated software testing, hardware bench test tools, ALM, PLM, and more. Current efforts by legacy vendors to create a common SaaS platform to span all these software categories and reach parity with best-of-breed tools is moving very slowly.   

RECOMMENDED READING: Benefits of End-to-End Traceability

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. 

RECOMMENDED READING: Requirements Management Guide: Requirements Traceability

Step Three | Management by Exception 

Once Live Traceability is achieved, engineering organizations can — for the first time — manage the end-to-end product development process in real time, identify exceptions to the process early, and take action to significantly reduce defects, rework, delays, and cost overruns.  

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requirements traceability live traceability

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.

RELATED POST: Requirements Management Guide: Requirements Traceability

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

Biggest Challenges

Q: Any major disruptions to product and systems development for engineering teams industry you’re anticipating in 2022?

Josh Turpen: I don’t think it’s a new disruption, but talent acquisition and management will continue to be a major theme for any head of engineering. Those not embracing a distributed workforce are in for serious pain. 

Q: What sorts of process adjustments do you think development teams will need to make to be successful in 2022?

Josh Turpen:  Asynchronous collaboration is critical in a distributed team. If your process and tools cannot keep contextual information and give users what they need when they need it, your team is wasting valuable time and increasing the likelihood of a bad outcome. 

requirements-management-hub

Predictions

Q: What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not?

Josh Turpen: Companies that embrace a best-of-breed approach to tools, collaboration, and the process will dominate those that don’t.  

Q: Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2022 approaches?

Josh Turpen: Our focus on Live Traceability™ will enable teams to leverage the best tools while maintaining context and enabling collaboration. We get up every morning focused on enabling our customers’ innovation and product success.  

Thanks for tuning into our 2022 Predictions Series! To see some of the incredible products, software, and systems our customers are building with Jama Connect, visit our CUSTOMER STORIES PAGE. 

 


requirements traceability

In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements traceability. 

As the product and software development process grows in complexity, with more and more teams adding information, it is becoming increasingly difficult to track requirements throughout the development lifecycle and for stakeholders to get a clear view. Every decision can have an impact on the requirement or the product itself.

How do you prevent your organization from wasting time and resources, repeating research and searching for information, and how do you ensure that final deliverables tie in directly to the initial business needs?

That’s where requirements traceability becomes very important.

In this webinar, we walk through the challenges of requirements traceability and how you can utilize Jama Connect to overcome them. Watch the webinar to see how to provide backward and forward visibility for requirements, but also other information about the product you are building. You will also see how easy it is to do an impact analysis, to generate reports, and get an overview of how your requirements tie together.

Read the abbreviated transcript below or watch the recording to learn more about:

  • Best practices for requirements traceability in a modern solution
  • The easy and intuitive way you link your information in Jama Connect
  • How Jama Connect can be leveraged to help with impact analysis
  • Understanding suspects and traceability views

Martijn Jansson: When we talk about capturing data, we all know data in our organizations in different forms exist, so we have documents, and we have Excel sheets, and those Excel sheets contain rows and all those rows have the data around a certain requirement on a certain topic. Now, that’s all fine, but what we actually are after, what we really want from the system is information. Information gets created by building relationships and structure around those data assets in the system. When you do that, you basically empower your users and the ecosystem around you to find that information and to go along the relationship you build to get context on the data they are looking at.  

 Now, you can go a step higher with that, and that would be the top of the triangle is the knowledge part. The knowledge part means that you actually have to consider capturing the decision on the change you do on the information. We’ll touch you a little bit on that today, but that’s also in part a possibility in the Jama Connect.  

 The benefits of getting that information related, as I stated, you can trace those relations back to get to the source of where your data started, what was the first part that you actually started off from, what was the decision point, where did you start with capturing that requirement? Also, at a higher level, you can have an overview of what will happen when you change that specific part of information or piece of information. What will the ripple down effect be when I start changing that specific part?  

 And then on the learning part on the actual knowledge part, you want to capture the why of a change, so why did we change it? If you go back in time and you look at those changes, you can actually find back why you made the change and why you decided to, for instance, have a status changed or a requirement changed.  

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.

 


Audit Trail

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! 

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.

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

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