GMP Audit for Data Governance: Who Owns the Data

What Data Governance Audits Cover

Data governance is the system that defines who is responsible for data, how data is managed, and how it is protected. It is the foundation for data integrity.

A GMP audit for data governance assesses whether ownership is defined, whether policies are in place, and whether controls are effective. The scope includes ownership, policies, controls, and monitoring.

The Regulatory Context

MHRA Data Integrity Guidance

The MHRA guidance addresses data governance as part of data integrity.

FDA 21 CFR Part 11 and Data Integrity

The FDA requires controls for electronic records and data integrity.

EU GMP Annex 11

Annex 11 covers computerized systems and data integrity.

PIC/S and WHO

PIC/S Guide PE 009 and WHO GMP guidelines cover data governance.

What Audits Focus On

Ownership

Ownership should be defined. The audit should check that responsibilities are assigned.

Policies

Policies should be in place. The audit should check that policies cover the data lifecycle.

Controls

Controls should be effective. The audit should check that controls are implemented.

Monitoring

Monitoring should be performed. The audit should check that monitoring is documented.

Common Findings in Data Governance Audits

Ownership That Is Not Defined

Policies That Are Incomplete

Controls That Are Not Effective

Monitoring That Is Not Performed

Introducing GxP Cellators for Data Governance Audits

GxP Cellators provides GMP audits for data governance covering ownership, policies, controls, and monitoring.

We work across FDA, EMA, Health Canada, MHRA, WHO, and PIC/S frameworks. Our auditors bring regulatory inspection and industry quality experience, and we deliver clear, prioritized reports with practical remediation guidance.