Audit-Proofing SOP Language and Format
Audit-Proofing SOP Language and Format How to Write and Format SOPs That Stand Up to Regulatory Audits Introduction: Why Audit-Proof SOPs Are Essential Standard Operating Procedures (SOPs) form the backbone of a GxP-compliant Quality Management System (QMS). During FDA, EMA, or PMDA inspections, SOPs are among the first documents reviewed. Poorly structured, ambiguous, or inconsistent…