Do you dread the day the auditors come knocking?
You're not alone. Many companies live in fear of software development audits. Providing an audit trail is stressful — especially when you're not properly tracking the development lifecycle.
That's where software traceability can help.
Software traceability is important for companies operating in any industry — but it’s critical for those in regulated industries.
Survive Your Next Software Development Audit
To survive a software development audit, you'll need traceability.
After all, regulatory bodies ensure product quality and safety. And they often include traceability guidelines in government regulations and international standards. Some examples of these include FDA 21 CFR Part 820, IEC 62304, and ISO 13485.
Is Traceability on Your Software Development Audit Checklist?
For regulated industries — like medical devices — traceability isn’t just “nice to have." It's actually a regulatory requirement.
Despite this fact, many companies treat traceability as just another item on the auditor’s checklist.
These companies put off 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. They know they may have missed a few (or more). 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. But then they end up crossing their fingers again, 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 be costing significant amounts of time and money.
If these companies implemented integrated 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 Integrated Traceability?
Integrated 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 weather eye on the project’s status.
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To be effective, integrated traceability requires the implementation of a good traceability strategy, along with a software tool like Helix ALM (formerly TestTrack) to provide a live stream of information.
4 Benefits of Traceability in the Development Process
Integrated traceability begins when the project begins. When you use integrated traceability, you'll benefit across the development process.
Because integrated 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. You'll be able to understand requirements decomposition. That is, you'll be able to:
- Link marketing requirements to product requirements.
- Link product requirements to system specifications.
2. Trustworthy Risk Analysis
Integrated traceability helps you identify and analyze risk. You'll be able to identify the code tied to each design, technical, or software specification. And as a result, you'll know:
- Where the high-risk code is.
- Where each requirement is implemented in the code.
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.
Take the case of a Helix ALM customer. This customer arrived at his office to find out he was having a surprise audit. But he had confidence in the company’s implementation of integrated traceability. So, he was able to deliver information to the auditor faster. That made it the fastest (and least stressful audit) he ever had.
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 topSolve 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 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.