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ASTM E2500

ASTM E2500

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What is ASTM E2500?

ASTM E2500 is a standard guide for verification of the performance of automated or computerized systems used in pharmaceutical and biopharmaceutical manufacturing. It focuses on a science- and risk-based approach to verification, emphasizing the critical aspects of the system that directly impact product quality and patient safety. It promotes leveraging supplier testing and documentation to reduce redundancy and encourages a lifecycle approach to system management.

What other technologies are related to ASTM E2500?

ASTM E2500 Complementary Technologies

GAMP 5 (Good Automated Manufacturing Practice) provides guidance for the validation of automated systems in pharmaceutical manufacturing, which aligns with the principles of ASTM E2500's science and risk-based approach to verification.
mentioned alongside ASTM E2500 in 4% (84) of relevant job posts
Kneat is a software platform used for managing validation processes in regulated industries. It can be used to implement the ASTM E2500 verification process, so it serves as a complementary tool.
mentioned alongside ASTM E2500 in 5% (53) of relevant job posts

Which organizations are mentioning ASTM E2500?

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