Glossary

Data Governance

The sum of the organisational and technical arrangements that assure data integrity, whatever the format or technology.

Source · PIC/S PI 041-1 (2021), §§5.1–5.2 and §13 Glossary

Details

Data governance places ownership, accountability, culture, procedures, and technical controls across the whole data lifecycle within the pharmaceutical quality system. Inspections cite systems that lack senior management accountability, data criticality and risk assessment, a culture in which errors are reported, control over contract giver access to data, and periodic review of effectiveness. Check the governance policy, the accountability structure, data flow and risk assessments, training and self-inspection, and management review and improvement plans.

Related sections

Related terms

Real inspection findings

See 134 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

PIC/S PI 041-1 (2021), §§5.1–5.2 and §13 Glossary

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