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 6.1.6: 6.1.6 Planning for Validation

The regulated company plans its computerized system validation at the appropriate levels: corporate or site policies define the overall approach, a validation master plan may summarize the systems, their status, planning and scheduling for a period or program of work, and each GxP regulated system has its own computerized system validation plan that defines how the system will become, and stay, compliant and fit for the use intended. Planning applies to new systems, to work triggered by change, and to periodic review, is approved by management and the quality unit as appropriate, and is the first thing a regulator is likely to ask for.

Maintained by Gerard BlokdykControl text last updated

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FDA 21 CFR Part 11 · 1 control

  • Part11.CSV Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

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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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