Computer System Validation Process (CSV)
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It also ensures data integrity, traceability and compliance with regulatory agencies such as the U.S. Food and Drug Administration (FDA-CFR21 Part 11) and the European Union’s Good Manufacturing Practice (GMP – Annexure 11).
In the pharmaceutical industry, any computers (software and hardware) involved in the following processes should be validated; R & D, laboratory lab notebook manual, batch record manufacturing process, analytical testing, stability process and material storage & packaging. Therefore, CSV is a stringent requirement as per national and international guidelines for the pharma industry at large.
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