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 4.3.2: 4.3.2 Operation: Service Management and Performance Monitoring

Internal and external support services alike are defined and managed through formal agreements such as service level agreements that define the services, service levels and the responsibilities of the provider and the regulated company, with provider capability assessed and monitored. System performance and health are monitored to a degree based on risk, using automated tools where possible, so that failures, availability, performance, configuration baseline drift and security issues are detected and fed into incident and problem management, as detailed in Appendices O2 and O3.

Maintained by Gerard BlokdykControl text last updated

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  • Clause 3 Suppliers and service providers

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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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