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Our Engineering & Validation Philosophy

  • Resources utilization is optimised by:
    - Involving validation requirements in the earliest stages of the project to ensure regulatory compliance and optimize operational output.
    - Integrating commissioning and validation to eliminate redundancy.
    - Providing a cGMP audit and risk analysis of the critical processes at the beginning rather then the end of the validation service.
  • The Validation Master Plan (VMP) is the cornerstone of the validation effort.
  • Validation is a unique opportunity for the customer to familiarize its personal with thte process and its critical operating parameters.
  • The owner has to ultimate responsibility for validation. This calls for a close collaboration with Approval Engineering and the customer throughout the validation efforts.

Copyright Approval Engineering AB / 08 mar 2006