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What is GAMP 5 in Computer System Validation

Computer System Validation (CSV) is a critical process in the pharmaceutical and healthcare industries to ensure that computer systems are operating in a reliable and compliant manner. GAMP 5, short for Good Automated Manufacturing Practice, is a guideline developed by the International Society for Pharmaceutical Engineering (ISPE) that provides a framework for the validation of automated systems. Understanding GAMP 5 is essential for companies looking to comply with regulatory requirements and maintain a high level of data integrity. This ultimate guide will delve into the key principles of GAMP 5 and provide insights on how to successfully implement CSV in your organization.

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06:12 PM - Jun 20, 2025 (UTC)

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