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RISK ASSESSMENTREFERENCE OUTLINE
Data Integrity (ALCOA+) Assessment
System-and-record data integrity assessment against the ALCOA+ attributes, with audit-trail and access-control review and a risk-ranked remediation register. Maps to Part 11, MHRA DI (2018), and WHO TRS 996 Annex 5.
REGULATIONS MAPPED
21 CFR Part 11MHRA GxP Data Integrity (2018)WHO TRS 996 Annex 5
DOCUMENT TYPE
Risk AssessmentLAST UPDATED
January 2025PURPOSE
A data integrity assessment that evaluates GxP records and systems against the ALCOA+ attributes and surfaces the gaps most likely to become inspection findings.
What's Inside
✓System and record inventory
✓ALCOA+ attribute evaluation
✓Audit trail and access-control review
✓Paper/hybrid and true-copy risks
✓Gap register and remediation priorities
How to Use It
1Inventory the GxP records and the systems that hold them
2Assess each against ALCOA+ attributes
3Review audit-trail configuration and access control
4Flag hybrid and true-copy weak points
5Rank gaps and assign remediation
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Scope and System / Record Inventory
2ALCOA+ Attribute Evaluation
3Audit Trail and Metadata Review
4Access Control and Segregation of Duties
5Paper, Hybrid, and True-Copy Risks
6Gap Register
7Risk-Ranked Remediation Plan
REGULATORY CONTEXT
21 CFR Part 11, the MHRA GxP Data Integrity guidance (2018), and WHO TRS 996 Annex 5 define the ALCOA+ expectations assessed here. The output is a prioritised, defensible remediation register.
MAPPED STANDARDS
21 CFR Part 11MHRA GxP Data Integrity (2018)WHO TRS 996 Annex 5
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