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The computer validation plan includes a computer validation plan (approach), specific activities required to implement 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
Computerized System Validation Planning Every validation effort (original validation and revalidation required for major changes) must have a computerized system validation plan that describes the procedures to be taken to validate the computerized system.
The computer validation plan must address the basic elements of the computer validation quality policy and describe the procedures that will be followed to ensure compliance with each basic element for the computerized system. If a particular element is marked as “not applicable”, the plan must include a reason why the element is not applicable.
The computerized system validation plan must be approved by the system owner. The system owner may designate someone else to sign the plan (ie, system responsible); However, this must be clearly stated. If quality assurance (QA) approval of the validation documentation is required (eg, for GMP compliance systems) or desired (eg, 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
The 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 may be tracked individually (eg, in a computer validation activities schedule), or may be included as part of the overall project plan for the computerized system.
Computer validation activities and responsibilities do not require system owner approval. The project team typically identifies, approves, and performs specific computerized system validation activities.
C. Computer Validation Report
The computer validation report must contain:
=>> Computer validation plan
=>> Results of complete computerized system validation activities (eg completed computerized validation activities table)
=>> A list of deliverables resulting from the activities (eg, SOPs, requirements, specifications, test scripts and results), and the location of the deliverables. This list serves as a cumulative “master index” to 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 computer validation reports (eg, GMPs).
