Validated System Status

“Nurocor, Inc. is pleased to announce that Nurocor MDR has achieved validated system status.” Huh? Right about now, you might be asking yourself “What is a validated system and why should I care?”  However, those of you working in the pharmaceutical industry already know the answer to this question – you are well aware that the US Federal government mandates under its Code of Federal Regulations (CFR) Title 21 (Food and Drugs) that systems used to manage electronic records must be validated “…to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.” This mandate, often referred to as CFR 21 Part 11, places a high standard of quality on software vendors providing products to the pharmaceutical industry. As Nurocor MDR is used by leading pharmaceutical enterprises to manage the clinical study standards used to define trials and deliver trial results to the FDA, it sits squarely within the scope of the CFR 21 Part 11 mandate.

Achieving validated system status for a configuration-driven product such as Nurocor MDR requires exhaustive testing at three levels:

• Requirements: we prove that the product can successfully execute the capabilities described by its specifications.
• Functional: we prove that the product is technically correct in its operation (i.e., traditional software release qualification testing).
• (Default) Configuration: we ensure the product’s configuration as shipped accurately specifies content and process workflows representing best practices for clinical study standards management.

For each level, we have to define test scripts for all specified capabilities, map them to their associated requirements, and record their execution results. Prior to product release, we must prepare a validation package containing all mapped test results for review and signoff by executive management. We then preserve this package and make it available to customer audit teams as they complete their own validation activities (yep, it’s turtles all the way down…). Sounds like a lot of work? It is, which is why validated system status is so valuable to both Nurocor and to our customers, ensuring that clinical study practitioners get the accurate and complete results they need as they work to deliver new medical treatments to the public.