CSV for Cloud-Based Systems: GxP Risks, Controls & Testing Cloud-Based CSV in Pharma: Managing GxP Risks, Controls & Testing As pharmaceutical companies shift from on-premise solutions to cloud-based platforms for LIMS, QMS, Document Management, and Manufacturing Execution Systems (MES), regulatory expectations around validation have intensified. Validating Software-as-a-Service (SaaS) and Infrastructure-as-a-Service (IaaS) systems within a GxP context requires a modern interpretation of Computer System Validation (CSV) principles, especially under 21 CFR Part 11 and EU Annex 11. This detailed guide offers a practical framework to validate cloud-hosted and SaaS platforms in pharma. It aligns with GAMP 5 guidelines and includes risk…