In Computerized System Validation (CSV), revalidation refers to the process of re-assessing and re-qualifying a system after significant changes or events that may impact its validated state. It ensures that the system continues to operate as intended and in compliance with regulatory requirements. Revalidation is often required in the following scenarios:
System Changes: If there are any updates to the software, hardware, or configurations, revalidation is necessary to ensure these changes do not affect the system’s performance, data integrity, or compliance.
Process Changes: When there are significant changes in the business processes or workflows that interact with the computerized system, revalidation ensures these modifications are accurately reflected in the system’s performance.
Regulatory or Compliance Updates: If new regulatory requirements or guidelines are introduced, revalidation is performed to ensure the system meets the updated standards.
Maintenance or Repairs: If critical repairs, maintenance, or migrations are made, revalidation checks that the system remains validated after these interventions.
Time-Based: Some systems may require periodic revalidation based on the organization’s internal policies or risk assessments to ensure the continued validated state over time.
Revalidation typically follows a similar process to the initial validation and includes updating documents such as user requirement specifications (URS), functional specifications (FS), validation protocols (IQ/OQ/PQ), and change control records.
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