Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist

Data integrity failures are a leading cause of FDA warning letters and import alerts. This audit checklist covers all elements of ALCOA+ data integrity compliance per FDA, MHRA, and WHO data integrity guidance.

Industry: Pharmaceutical & Life Sciences
Frequency: Quarterly
Estimated Time: 45-60 minutes
Role: QA Manager / IT Compliance Manager
Total Items: 32
Compliance: FDA Guidance for Industry - Data Integrity and Compliance with Drug CGMP (December 2018), MHRA GMP Data Integrity Definitions and Guidance (March 2018), WHO Technical Report Series No. 1010 Annex 4 Data Integrity Guidelines, EU GMP Annex 11 Computerised Systems

ALCOA+ Core Principles

Verify data meets ALCOA+ standards.

All data entries attributable to the person who created them (individual login, handwritten initials)?
All records legible, durable, and permanent (no pencil, no white-out)?
Records created at time of activity - no retroactive entries?
Original records preserved - no transcription errors or unofficial copies replacing originals?
Data reflects actual observations without manipulation?
Records complete and consistent - no gaps or deletions without explanation?

Audit Trails

Verify audit trail completeness and review.

Audit trails enabled in all GxP computerized systems?
Audit trails reviewed as part of batch record review?
No unauthorized data changes, deletions, or system clock modifications found?
Audit trail data backed up and protected from modification?
Paper record corrections made with single line through, initials, and date only?

Access Controls and User Management

Verify system access controls are appropriate.

Each user has unique login credentials - no shared accounts?
Access privileges match job roles - no excess privilege?
Access for departed or transferred employees deactivated promptly?
Administrative access restricted to IT/system owners - not QC analysts?
Password policy enforcing complexity, expiry, and no sharing?

Hybrid Systems (Paper and Electronic)

Review hybrid data system controls.

Complete data set defined: what constitutes the raw data, where it resides?
Printouts from electronic systems controlled and linked to electronic raw data?
No evidence of selectively reporting results (testing into compliance)?
All analytical runs (including voided) retained and accessible?
Standalone computers (unnetworked instruments) reviewed for unauthorized files?

Data Integrity Culture and Training

Assess data integrity culture and awareness.

All GxP personnel trained on data integrity expectations?
Data integrity policy or SOP established and communicated?
Culture supports reporting errors without fear of disproportionate blame?
Data integrity included in self-inspection and internal audit program?
No repeat data integrity observations from previous audits indicating cultural issues?

Documentation

Verify data integrity documentation.

Data integrity risk assessment completed for critical GxP systems?
Data integrity remediation plan in place for any gaps identified?
Periodic review of data integrity controls scheduled and completed?
Previous data integrity audit findings closed with verified effectiveness?
Any regulatory commitments related to data integrity met on schedule?
Complete data integrity audit report prepared?

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Why Use This Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist?

This pharmaceutical data integrity and alcoa plus compliance checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / it compliance manager professionals, this checklist covers 32 critical inspection points across 6 sections. Recommended frequency: quarterly.

Ensures compliance with FDA Guidance for Industry - Data Integrity and Compliance with Drug CGMP (December 2018), MHRA GMP Data Integrity Definitions and Guidance (March 2018), WHO Technical Report Series No. 1010 Annex 4 Data Integrity Guidelines, EU GMP Annex 11 Computerised Systems. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist cover?

This checklist covers 32 inspection items across 6 sections: ALCOA+ Core Principles, Audit Trails, Access Controls and User Management, Hybrid Systems (Paper and Electronic), Data Integrity Culture and Training, Documentation. It is designed for pharmaceutical & life sciences operations and compliance.

How often should this checklist be completed?

This checklist should be completed quarterly. Each completion takes approximately 45-60 minutes.

Who should use this Pharmaceutical Data Integrity and ALCOA Plus Compliance Checklist?

This checklist is designed for QA Manager / IT Compliance Manager professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.