GAMP5, 2nd edition, is an update of the globally recognised guide for validating computerised systems in the pharmaceutical industry, published by the International Society for Pharmaceutical Engineering (ISPE). It contains extended guidelines and best practices for validating computerised systems to meet regulatory requirements.
The International Society for Pharmaceutical Engineering (ISPE) has released an updated version of the globally recognized guide for validating computerized systems in the pharmaceutical industry, known as GAMP5. The second edition contains better and extended guidelines and best practices to meet current regulatory requirements. It is also called “GAMP5 second edition” and includes updated guidelines reflecting the latest regulatory requirements and developments in the pharmaceutical industry. The new version includes specific sections addressing cybersecurity and data integrity and emphasises modern technologies such as artificial intelligence and machine learning. These updates make the GAMP5 second edition an indispensable tool for companies to effectively and compliantly validate their computerized systems.
