Challenge: A pharmaceutical client needed to ensure their software complied with stringent FDA regulations for drug management and patient safety. Manual compliance testing was time-consuming and error-prone, risking potential compliance breaches.
Solution: Qassert conducted comprehensive compliance testing, validating all system functionalities against FDA guidelines. Automated scripts were developed to ensure continuous compliance testing for every release, saving significant manual effort.
Outcome: The system achieved 100% compliance, and all critical vulnerabilities were addressed before the audit. The client passed the FDA audit with zero non-conformities, securing a successful product launch and market approval.