GAMP 5 - Good Automated Manufacturing Practice
Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 2.1.1: 2.1.1 Product and Process Understanding

Understanding of the product and the process underpins science-based and risk-based decisions about computerized systems: the specification, verification and operational controls of a system are scaled to what the supported business process needs, its critical quality attributes and critical process parameters, and the regulated data it carries. The guide expects the organization to understand the process the system supports before it defines requirements, so that effort goes to the aspects that bear on patients, product quality and the integrity of data, and it treats maps of the business process and diagrams of data flow as the way that understanding is captured and kept current.

Maintained by Gerard BlokdykControl text last updated

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Other controls in Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice

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