GAMP 5 - Good Automated Manufacturing Practice
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 4.3.4: Operation: Change and Configuration Management

What does 4.3.4 require?

Operational changes to configuration items, including business processes, application software, configuration, data, infrastructure and services, are defined, authorized, assessed for impact and risk, carried out, tested in proportion to risk including regression, and approved before release, with impacted documentation, procedures, training, risk assessments and service agreements updated so the configuration baseline is maintained. Configuration management identifies the configuration items, controls changes to them, accounts for their status and evaluates that the records reflect the as-built state, supports restoration after a disaster, and covers standard, emergency, temporary and provider-driven changes, as detailed in Appendix O6.

Maintained by Gerard BlokdykControl text last updated

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  • Clause 10 Change and configuration management

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Other controls in Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice

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