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 6.1.8: 6.1.8 Data Governance

Data governance is the arrangement of policies, ownership, roles, processes and technical controls that ensures regulated data is created, processed, reviewed, used, retained and disposed of with its integrity protected through its life cycle across all the systems that hold it. The regulated company defines data owners and data stewards, maps data flows and identifies primary records, applies the ALCOA+ attributes, sets classification and handling rules, and integrates data governance with risk management, training and culture so that behavioral, procedural and technical controls work together; the ISPE GAMP records and data integrity guidance gives the detail.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • PICSGMP-4 Chapter 4: Documentation - System, Record-Keeping, Data Integrity

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.