Documentation Preparation

cGMP Compliant / Live & Auditable

→ SOP Preparation & Revision

→ Validation Documentation (URS, DQ, IQ, OQ, PQ)

→ Data Integrity Documentation (DI Plans, Gap Assessments, Remediation Plans)

→ Change Control Documentation

→ Deviation, Investigation & CAPA Reports

→ Risk Assessments (FMEA - Failure Mode Effects Analysis)

→ Qualification & Commissioning Protocols

→ Periodic Reviews