Heath Care - G.A.M.P. 4 Validation Procedures

User Requirement Specification (URS):  Defines expectations of proposed System Equipment.  Typically Customer-provided

Functional Specification:  Describes detailed Equipment Functions.  Typically Supplier-provided

Design Specification:  Documents how the System is to be Built.  Typically includes: Mechanical & Electrical Drawings, Schematics, Timing Charts, Flow Charts, B.O.M.’s,

Installation Qualification (IQ):  Validate Integrated Systems against Design Requirement Compliance

Operational Qualification (OQ):  Validate Machine’s main Critical Functions & Calibration Documents.  Verify Machine Efficiencies (F.A.T.’s and S.A.T’s)

Performance Qualification (PQ):  Establishes evidence that the Equipment manufactures Products that meet Final Device Specification in a Production Environment

Risk Assessment:  Ascertains and Priorities potential System and Machine Failures and Recovery Modes

PFEMA:  Process Failure Effects Modal Analysis

21 CFR11 Validation:  Controlled Criteria Parameter Management via Login Password Authority to “Change History” data files per 21 CFR11.