In Computerized System Validation (CSV), a GAP analysis is the process of identifying and evaluating the differences (or "gaps") between the current state of a computerized system and the regulatory or operational requirements that it must meet. This analysis helps determine what changes, improvements, or validations are needed to ensure the system complies with relevant regulations, such as GxP (Good Practice) guidelines, FDA 21 CFR Part 11, or EU Annex 11.
The key steps in a GAP analysis for CSV include:
1. Reviewing Requirements: Comparing the system's current documentation, configurations, and functionalities against regulatory standards and business requirements.
2. Identifying Gaps: Pinpointing areas where the system falls short of meeting the required validation or compliance standards.
3. Risk Assessment: Evaluating the potential risks associated with each identified gap and prioritizing them based on their impact on product quality, data integrity, and regulatory compliance.
4. Action Plan: Developing a plan to address and close the gaps, which may involve system upgrades, process improvements, or additional testing and validation activities.
5. Implementation: Executing the corrective actions and retesting the system to ensure the gaps are resolved.
GAP analysis is crucial for ensuring that computerized systems remain in compliance with changing regulations and continue to operate as intended.
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