•INV, DEV, VAR, OOS, OOT, CC, CAPA
•Manufacturing Validation Protocols / Executed Val’s / Reports
•Packaging Validations Protocols / Executed Val’s / Reports
•Analytical Method Validation/Verification Protocols / Executed Val’s or Ver’s / Reports
•Stability Protocols / Reports
•IQ/OQ/PQ Protocols
•IQ/OQ/PQ Protocols / Executed IQ/OQ/PQ
•Executed PM/Cal
•SOP’s
•Validation and Commercial MBR’s
•Validation and Commercial PWO’s
•Data integrity
•Methods
•Specifications
•Results
•Hosting Regulatory and Client Audits
•Complaint Handling Unit
•Material Review Board
•Annual product reviews
