GAMP 5 - Good Automated Manufacturing Practice
Operation appendices O1 to O13 (handover, support services, monitoring, incidents and problems, CAPA, change and configuration, periodic review, backup, continuity, security, administration, archiving) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice O3: Appendix O3 System Monitoring

The need for and extent of system monitoring follow from the business risk and the risk to patients, product quality and the integrity of data, judged against what kind of system it is and how exposed it is externally; monitoring may cover a system, a group of systems or an infrastructure environment and reports on failures, availability, performance, drift from the configuration baseline and security problems, feeding incident and problem management and improving controls. The system owner ensures risk-based monitoring is in place with administrators and IT and participates in handling detected incidents, and the process and data owners agree the scope and participate. Considerations include system and data availability, performance and resources, network routing, loading and outages, configuration compared with templates, batch job failures including backups, communication faults on interfaces and instruments, faults in software, operating system and hardware, printer queues, alarms and events, security vulnerabilities and intrusion detection. Automated tools are used wherever possible to detect, alert and, where available, self-rectify by adjusting resources or resetting configuration to the template, and manual monitoring tasks are defined and scheduled in service management tools or administration plans with tasks, roles, frequency and reporting stated.

Maintained by Gerard BlokdykControl text last updated

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ISO 27002:2022 · 1 control

  • 8.16 Monitoring activities

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Other controls in Operation appendices O1 to O13 (handover, support services, monitoring, incidents and problems, CAPA, change and configuration, periodic review, backup, continuity, security, administration, archiving) – GAMP 5 - Good Automated Manufacturing Practice

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