Computerized System Validation Planning and Execution

Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Computer Validation Report as documented assurance that all activities required to validate the computerized system have been successfully completed.

A. Computer Validation Plan
Each validation effort (original validation and re-validation required by extensive changes) must have a Computerized System Validation Plan that describes the approach taken to validate the computerized system.

The Computer Validation Plan must address the Basic Elements in the Computer Validation Quality Policy and describe the approach that will be taken for the computerized system to comply with each Basic Element. If a particular Basic Element is identified as “not applicable,” the plan must include a reason for why the Basic Element does not apply.

The Computerized System Validation Plan must be approved by the System Owner. The System Owner can designate someone else to sign the plan (e.g., System Responsible); however, this must be clearly noted. If Quality Assurance (QA) approval of the validation documentation is required (e.g., for GMP compliance systems) or desired (e.g., for GCP, GLP systems) before the computerized system is used in production, then the appropriate QA group must approve the Computer Validation Plan.

B. Computer Validation Activities
Specific activities and associated responsibilities required to complete the Computer Validation Master Plan must be documented; however, they do not need to be included in the plan. Computer validation activities can be tracked separately (e.g., in a Computer Validation Activities Table), or included as part of the overall project plan for the computerized system.

Computer validation activities and responsibilities do not require the approval of the System Owner. The project team normally identifies, approves, and performs specific computerized system validation activities.

C. Computer Validation Report
– The Computer Validation Report must contain:
– The Computer Validation Plan
– The results from completed computerized system validation activities (e.g. completed Computer Validation Activities Table)
– A list of deliverables generated from the activities (e.g., SOPs, requirements, specifications, test scripts and results), and the location of the deliverables. This list serves as the cumulative “master index” for the system’s original Validation Documentation and must be updated for each subsequent re-validation or change.
– A statement or report summarizing the overall results of the validation indicating the suitability of the system for use.

The Computer Validation Report must be approved by the System Owner before the system is released for use. The System Owner assures that all validation activities have been completed. Regulations may also require Quality Assurance approval of the Computer Validation Report (e.g., GMPs).

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