Overview
For the past two decades, detailed documentation and software validation have been the norm across pharmaceutical, medical device, biopharma and biotech companies. The regulatory framework, while assuring compliance, unintentionally creates challenges with adopting new technology solutions that could enhance efficiency, product quality and patient outcomes. Recognizing the need for change, in September 2022, the FDA released a new guideline, Computer Software Assurance (CSA), aimed at transforming the validation process.
Our value proposition for CSA implementation
CSA implementation proof points supported with whitepapers and blogs
Modern risk-based approach that provides an evaluation of compliance maturity and readiness
Process models and templates that are CSA-compatible
Industry thought leadership engagement with real-time access to case studies and learning resources
Digital validation platform provides access to quick, deployable tools
End-to-end validation service with full CSV implementation, supported by experienced SMEs