Schedule M · 21 CFR 211

OSD · Microbiology documents

EM, water, sterility, MLT, media, disinfectant validation

All departmentsMicrobiologyQCQAProductionEngineeringWarehouseRegulatoryEHS
All typesSOPValidationQualificationCalibrationSite Master FileTrainingFormat / LogCAPARoot Cause Analysis (RCA)Deviation / InvestigationRisk AssessmentChange ControlRegulatory DocumentAudit Checklist / ReportGap AssessmentAPQR / PQRData Integrity