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Template Title Purpose Comments
Validation Master Plan
To provide a template for creating a validation master plan.
The VMP 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.
Validation Master Plan Item Information Form To collect information about items that might require validation so that the need for validation can be assessed and a priority assigned in the Validation Master Plan. Information is recorded about the item and its uses. The need for Part 11 compliance and validation is evaluated and the judgments recorded.
Validation Plan To provide a template for creating a plan for the validation of a specific system or piece of equipment. None.
Computer System Specification To document the existing hardware and software configuration of a system. The configuration is used as the basis for the IQ, for detailed documentation of the system as validated, and as the blueprint for rebuilding the system in case of a need to replicate or restore the system as validated. Detailed examples are provided for server and application configurations.
Computer System Technical Requirements To provide a template that makes the preparation of technical requirements simple and quick. Technical requirements are used to define what hardware and software is needed by a new application The template includes examples of requirements for server and desktop hardware and software, infrastructure services, and other software needed by the application. Simply fill in the values that are appropriate to your system and add additional requirements

IQ (Installation Qualification)

To provide a template for creating an Installation Qualification protocol for the validation of a specific system or piece of equipment. None.
OQ (Operational Qualification) To provide a template for creating a Operational Qualification protocol for the validation of a specific system or piece of equipment. None.
PQ (Performance Qualification) To provide a template for creating a Performance Qualification protocol for the validation of a specific system or piece of equipment. None.
Validation Reports To provide a template for creating a validation report for a specific system or piece of equipment. None.