Traceability has tremendous value for companies operating in any industry, but it’s critical for those in regulated industries. Traceability guidelines are included in a number of regulations, and are expected in an audit.
That means some of you accomplish this manually, which makes for an arduous compliance audit. But there is a much easier way to have accurate, immediate traceability whenever you need it.
Click here to watch our on-demand webinar, How to Improve Your Regulatory Traceability
What is a Compliance Audit?
A compliance audit is an external, formal review of an organization’s operations and procedures. The goal is to check that a company and its products meet the rules, standards, laws, and regulations applicable to that business. Failing an audit can result in fines, or even discontinuation of a service or product until standards are met.
Back to topCompliance and Traceability
Regulatory bodies recognize the impact traceability has on product quality and safety, which is why traceability guidelines are included in several government regulations and international standards, such as:
- FDA 21 CFR Part 820 (specifically, Section 3)
- IEC 62304
- ISO 13485
- General Principles of Software Validation (GPSV)
So for regulated industries — like medical devices — traceability isn’t just “nice to have." It's actually a regulatory requirement.
Back to topChallenges of Manual Traceability
Despite the fact that traceability is required, it’s sometimes treated as just another item on the auditor’s checklist.
In these cases, companies delay traceability tasks until the end of the process. And then they go through the tedious, manual process of connecting all of the product artifacts and assembling a traceability matrix. If documents have not been kept up to date, they may miss a few (or more). [PR1] So come audit time, they cross their fingers and hope for the best.
If they're “lucky,” the auditor picks the artifacts that are traced, hoping no undiscovered hazards are hiding in the final product. If they're not lucky, they get slapped with warning letters, delays, and the potential of some very steep fines.
Building the trace matrix at the end of the development process defeats the whole goal of traceability — ensuring product quality and safety by effectively managing change. What’s more, putting it off could severely compromise patient outcomes and product safety.
If these companies implemented real-time traceability, however, they could improve product quality, cut costs, and spend far less time and effort assembling the reports auditors require.
Back to topWhat Is Real-Time Traceability?
Real-time traceability, also understood as integrated or automated traceability, is the ability to attain to-the-minute status information on every aspect of the product development lifecycle.
Traceability links all artifacts contributing to the development of your product. It makes it easy to analyze data, generate traceability reports, and keep a close eye on the project’s status.
To be effective, traceability requires the implementation of a good traceability strategy, along with a software tool like Helix ALM to provide a live stream of information.
4 Benefits of Traceability in the Development Process
Because real-time traceability begins when the project begins, it offers a host of benefits throughout the development process — from design reviews to risk analysis, gap analysis to verification and validation.
1. Easier Design Reviews
Integrated traceability makes design reviews easy. To properly review a design requires that you understand and can quickly access its requirements. Real-time traceability ensures that upstream and downstream requirements are only a click away.
2. Trustworthy Risk Analysis
Integrated traceability helps you identify and analyze risk. You'll be able to identify the risks tied to each design, technical, or software specification. And as a result, you'll know:
- Where the high-risks exist.
- Where you might have mitigation gaps.
3. Timely Gap Analysis
Integrated traceability helps you identify gaps in:
- Documentation
- Testing
- Risk analysis
Seeing these gaps helps you fill them — before an auditor comes knocking at the door. It also gives you an easy way to provide evidence for any audits that pop up unexpectedly.
4. Verification and Validation
Integrated traceability helps you meet requirements. You'll be able to verify and validate that requirements were implemented correctly. And you'll be able to make sure the product functions the way the user needs it to.
Back to top
Solve Software Problems — Before They Start
Most software problems can be traced to errors made during the design and development process (General Principles of Software Validation).
By implementing traceability across development, you'll be able to spot problems early. And when you do that, you'll be able to solve these problems with minimal cost and effort.
Plus, maintaining traceability throughout the process makes it easier to assemble a trace matrix.
Pass Your Next Audit
Learn how to bring quality products to market faster — and create the audit trail you need.