Survive Your Next Audit with Real-Time Traceability
Traceability has tremendous value for companies operating in any industry, but it’s critical for those in regulated industries. Regulatory bodies recognize its impact 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, traceability isn’t just “nice to have”—it’s actually a regulatory requirement. Despite this fact, many companies treat it as just another item on the auditor’s checklist. Sound familiar? If so, you probably put off traceability tasks until the end of the process, and then go through the tedious, manual process of connecting all of the product artifacts and assembling a traceability matrix. You know you may have missed a few (or more), so come audit time, you cross your fingers and hope for the best. If you’re “lucky,” the auditor picks the artifacts that are traced—but then you end up crossing your fingers again, hoping no undiscovered hazards are hiding in your final product. If you’re not lucky, you’re in for warning letters, delays, and the potential of some very steep fines. Building your 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 be costing you significant amounts of time and money. When you implement real-time traceability, however, you can improve product quality, cut costs, and spend far less time and effort assembling the reports the auditor requires.
What Is Real-Time Traceability?
Real-time traceability is the ability to attain to-the-minute status information on every aspect of your 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 weather eye on the project’s status. To be effective, real-time traceability requires the implementation of a good traceability strategy, along with a software tool like TestTrack to provide a live stream of information.
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.
Real-time traceability aids in design reviews by making it easy to understand requirements decomposition through linking. For example, marketing requirements link to product requirements, which link to system specifications.
By the same measure, real-time traceability can also aid in identifying risk-based and safety-based requirements by including risk and hazard analysis within your traceability implementation. You can also identify the software code that ties to each design, technical, or software specification, making it much easier to identify high-risk code and where each requirement is implemented in the code.
Traceability also helps you identify gaps in your documentation, testing, and risk analysis. Seeing these gaps enables you to ensure they’re filled by the time an auditor comes knocking at your door. By having this information at your fingertips, you now have an easy way to provide evidence for any audits that pop up unexpectedly. This was particularly helpful for a Seapine client who arrived at his office to find he was having a surprise audit that day. Because of the confidence he had in the company’s implementation of real-time traceability, he was able to deliver information to the auditor faster, which in turn reduced the time it took for the audit. He said it was the fastest that he ever had an auditor in and out of the building.
Verification and Validation
Finally, real-time traceability helps to ensure that requirements are implemented correctly both from a verification and validation point of view. You can quickly make sure the requirement has been implemented correctly and the product functions for the user as intended.
Solve Problems Early
As the GPSV states, the vast majority of software problems can be traced to errors made during the design and development process. Real-time traceability gives you the power to spot problems early, so you can correct them while the cost and effort to do so is low. And as for the tedious process of assembling the trace matrix? Because you’re maintaining traceability throughout the process, you can generate a matrix on demand, at any point. In TestTrack, it takes just a couple of clicks—and you don’t miss a thing.
To take a deeper dive into real-time traceability, watch How to Survive an Audit with Real-Time Traceability.