Validation Master Plan = VMP / VP

Validation / Qualification / Testing (FAT / SAT)

• - DQ (Design Qualification – URS, RA, FS, DS)
• - IQ (Installation Qualification)
• - OQ (Operational Qualification)
• - PQ (Performance Qualification)

Documentation

• - Protocol / Report
• - Summary Report

SOP’s

GMP support

• - Review
• - Change Control
• - Deviation

Calibration