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 6.1.7: 6.1.7 Continual Improvement Activities

The regulated company seeks continual improvement of its computerized system processes by developing understanding of how the life cycle framework is working in practice and by using metrics. Understanding comes from reviewing the outcomes of projects, periodic reviews, incidents, changes, audits and inspections and from lessons learned; metrics, such as defect escape rates, change volumes, incident trends, review outcomes and cycle times, are defined, collected and used to identify where processes are over- or under-engineered, and the results feed updates to policies, procedures, templates, tools and training.

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

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