Health Care - Validation Procedures

Design Qualification (DQ):  Assembly Machine Description

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)

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