August 2009 - Aegis Solutions recently completed a third-party software validation for quality assurance testing of a pharmaceutical product.  The product, ingested by patients to enhance certain medical diagnostic procedures, was being certified by the United States Food and Drug Administration.  Part of the certification is focused on the production process for the product including all quality assurance systems.  The client required that the  validation be performed by a party not involved in writing the software, thus providing an independent assessment of the software functionality and integrity.

Aegis Solutions was selected by the client, who is one of the largest medical and healthcare product providers in the world, because of our expertise with National Instruments LabVIEW® software and development environment and because we had previously developed other software packages for the client. 

Our staff developed a validation test plan based on the FDA "General Principles of Software Validation" and 21 CFR Part 11 Industry Guidance.  The Validation Plan was reviewed and approved by the client, testing was performed on a module-by-module basis and a system level basis, and reports were generated documenting the test results and all discrepancies between the client's software requirements and design documents and the actual software operation and functionality.

This was an intensive validation process due to the nature of the software's intended use.  Our staff stepped up to the challenge and conducted a validation that enabled the client to complete their FDA approval process.