fda requirements for software validation

Common Audit Findings During Vendor Qualification

Common Audit Findings During Vendor Qualification Common Audit Findings During Vendor Qualification Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first critical step in vendor qualification is developing a comprehensive User Requirements Specification (URS). A URS outlines…

Establishing Acceptance Criteria for Swab and Rinse Testing

Establishing Acceptance Criteria for Swab and Rinse Testing Establishing Acceptance Criteria for Swab and Rinse Testing In the pharmaceutical and biologics manufacturing industries, ensuring the efficacy of cleaning processes is paramount to maintain product integrity and compliance with regulatory expectations.…