GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.2.11: 6.2.11 Maintaining System Compliance During Operation

Keeping the system compliant while it is in use is the regulated company's responsibility. It meets it by putting in place suitable operational and system management procedures for handover, support services, monitoring, incidents and problems, CAPA, change and configuration management, periodic review, continuity, security, system administration and records management, with the degree of formality matched to the system, as section 4.3 and the operational appendices explain.

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