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Heath Care - G.A.M.P. 5 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.



Health Care

Office and Consumer

Office and
Consumer Products



Sensors and Semiconductors

Sensors and

Solar Power
Fasteners and Robotic Systems

Fasteners and
Robotics Systems


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 Calvary Automation Systems · 855 Publishers Parkway. · Webster, NY 14580 · Tel:585-347-6127 · Fax:585-347-6125 ·