Periodic Validation Assessment

 Periodic validation assessment is a process that involves reviewing and evaluating the effectiveness of a validated process, system, or product over time. The goal of periodic validation assessment is to ensure that the validated state of the process, system, or product is maintained throughout its lifecycle and that it continues to meet regulatory requirements.

Periodic validation assessments typically involve the following steps:

1.    Review of the Validation Master Plan (VMP): The VMP is reviewed to ensure that it is still relevant and accurately reflects the current state of the process, system, or product. Any changes to the process, system, or product since the last validation assessment are noted.

2.    Review of the Validation Protocol: The validation protocol is reviewed to ensure that it is still appropriate and that the acceptance criteria and testing requirements are still relevant. Any changes to the acceptance criteria or testing requirements are noted.

3.    Review of the Validation Report: The validation report is reviewed to ensure that it accurately reflects the results of the validation activities. Any discrepancies or deviations from the acceptance criteria are noted.

4.    Review of Change Control: The change control process is reviewed to ensure that any changes to the process, system, or product have been evaluated and tested to ensure that they do not negatively impact the validated state.

5.    Performance Monitoring: The performance of the process, system, or product is monitored to ensure that it continues to meet the predetermined acceptance criteria. Any trends or deviations from the acceptance criteria are investigated and addressed.

Based on the results of the periodic validation assessment, any necessary corrective actions or revalidation activities are identified and implemented to ensure that the process, system, or product continues to be in a validated state.

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