Computerized System Validation Master Plan – Free Word file download




Attention: This validation plan is applicable to software or computerized systems only. It is not applicable to physical equipment

It defines the phases of validation and, after validation, the principles to maintain systems in a validated state. Its goal is to set the principles to:

  • Bring evidences that involved processes are compliant with quality and regulatory requirements,
  • Ensure the safety and integrity of critical data.


The validation of each computerized system is described in a Validation Protocol (form XXX, see template), which implements the principles of this procedure. The results of the validation are described in a Validation Report (form XXX, see template).


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Manostaxx – Industrial Management Consulting

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