Companies who have a number of computer systems and are just starting to validate them need to determine what really needs to be validated and the priorities for the validation. Everything cannot be done at the same time; a plan for validation and achieving Part 11 compliance is needed. This template describes the information that needs to be presented in a validation master plan and provides examples. 9 pages
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Companies who have a number of computer systems and are just starting to validate them need to determine what really needs to be validated and the priorities for the validation.
This template describes the information that needs to be presented in a validation master plan and provides examples. 9 pages
The Validation Master Plan is a high level plan that identifies all the computerized business systems at a site (or for an organizational unit) that require validation, sets priorities based on defined criteria, and states time frames for such validations.
