Pharmaceutical Data Integrity and ALCOA+ Compliance Audit Checklist

Data integrity failures are a primary driver of FDA warning letters, import alerts, and consent decrees. This audit systematically assesses data integrity controls across paper-based and electronic systems against ALCOA+ principles and regulatory expectations.

Industry: Pharmaceutical & Life Sciences
Frequency: Annual / Pre-Regulatory Inspection
Estimated Time: 60-90 minutes
Role: QA Manager / IT Compliance Manager
Total Items: 33
Compliance: FDA Data Integrity and Compliance with CGMP Guidance (2018), MHRA Guidance on GMP Data Integrity (2018), WHO Guidance on Good Data and Record Management Practices (2016), EU GMP Annex 11 Computerised Systems, FDA 21 CFR Part 11 Electronic Records Electronic Signatures

ALCOA+ Principles Assessment

Verify data meets ALCOA+ requirements.

All data entries attributable to individual responsible for the action?
All records legible and permanently recorded in indelible ink or electronic format?
Data recorded at the time the activity was performed (no backdating)?
Original data preserved and not transcribed without retention of original?
Data accurately reflects the actual observations and is not manipulated?
Complete data set including all raw data, anomalies, and excluded data documented?

Electronic System Controls

Verify electronic system data integrity controls.

Audit trails enabled and active for all GMP electronic systems?
Audit trails regularly reviewed and part of batch record review?
All users have unique individual logins - no shared accounts?
Access control matrix with role-based permissions documented and enforced?
Former employee and contractor accounts deactivated promptly?
Laboratory instrument computers not accessible to users with local administrator rights?

Paper Record Controls

Verify paper record data integrity.

All corrections made correctly: single line strikethrough, initials, date, reason?
No use of correction fluid (Wite-Out), overwriting, or obliterating original entries?
No data recorded in pencil in batch records or laboratory notebooks?
Controlled forms used with version number and effective date?
No loose paper records or Post-it notes with data not attached to formal record?

Raw Data and Retention

Verify raw data availability and retention.

All raw data (chromatograms, spectroscopy data, instrument printouts) retained?
No evidence of data deletion or audit trail clearing in electronic systems?
Regular backup of electronic data with tested restoration?
Data retention schedule compliant with regulatory requirements (minimum per 21 CFR 211.68)?
Archived records retrievable within required timeframe?

Laboratory Data Integrity

Assess QC laboratory data integrity controls.

QC results reviewed by second person before reporting?
No evidence of testing into compliance (excessive repeat testing until in-spec)?
All OOS investigations properly documented including all test data?
All analysts qualified for tests they perform?
Sample chain of custody documented from receipt through disposal?

Management Oversight and Culture

Assess data integrity culture and management oversight.

All relevant personnel trained on data integrity expectations and consequences?
Data integrity policy in place with clear expectations and escalation path?
Mechanism for anonymous reporting of data integrity concerns?
Data integrity metrics reviewed at management review?
Periodic data integrity audit conducted by QA or independent party?
Data integrity included in self-inspection program?

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Why Use This Pharmaceutical Data Integrity and ALCOA+ Compliance Audit Checklist?

This pharmaceutical data integrity and alcoa+ compliance audit checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / it compliance manager professionals, this checklist covers 33 critical inspection points across 6 sections. Recommended frequency: annual / pre-regulatory inspection.

Ensures compliance with FDA Data Integrity and Compliance with CGMP Guidance (2018), MHRA Guidance on GMP Data Integrity (2018), WHO Guidance on Good Data and Record Management Practices (2016), EU GMP Annex 11 Computerised Systems, FDA 21 CFR Part 11 Electronic Records Electronic Signatures. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

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

This checklist covers 33 inspection items across 6 sections: ALCOA+ Principles Assessment, Electronic System Controls, Paper Record Controls, Raw Data and Retention, Laboratory Data Integrity, Management Oversight and Culture. It is designed for pharmaceutical & life sciences operations and compliance.

How often should this checklist be completed?

This checklist should be completed annual / pre-regulatory inspection. Each completion takes approximately 60-90 minutes.

Who should use this Pharmaceutical Data Integrity and ALCOA+ Compliance Audit 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.