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Validation Processes

Assembly and Test Process Validations are an integral, process-driven requirement applied against all Calvary-supplied equipment and are most specifically applied against the machines and systems which produce safety and health related products.  Validations may be as simple as Dry-cycling the machine, CpK, Gage R&R and Overall Equipment Efficiency studies, which are an integral procedure that is mandated via Calvary’s Standard Debug Check List or the procedures may be as involved as the F.D.A. or GAMP4 validation procedures.

Go Directly to Page:  Calvary Standard Validation Procedures/F.D.A. Production Release Validation Procedures/G.A.M.P. 4 Validation Procedures

Calvary Standard Validation Procedures

  • 24-40 Hour Machine Dry Cycling
  • Cycle Rate Performance: Station and System                         
  • CpK, Gage R&R and Overall Equipment Efficiency Studies
  • Lot Traceability and Data Collection Integrity Validations
  • Mastering and Calibration Routine Validation

F.D.A. Production Release 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

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.   

   

Click Here:  Healthcare-G.A.M.P 4 

 

            

 



 

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