About this resource
Assess your data integrity status before your next audit
Data integrity failures are one of the most common reasons for FDA warning letters, EU GMP non-compliance findings, and clinical trial data rejections. The ALCOA+ framework — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available — is the standard against which all regulated laboratory data is assessed.
This checklist gives your QA team a structured, printable tool to assess your current compliance status across every principle, identify gaps before an inspector does, and assign ownership of remediation actions.
What's included
4 checklist items per principle — 36 items total
Violation notes for the most commonly cited principles
Gap owner and target date tracking table
Scoring guide — know where to focus first
Printable A4 format — use in meetings or audits
Aligned with FDA 21 CFR Part 11, EU Annex 11 & MHRA guidance
Principles covered
Who this is for
Whether you're preparing for an FDA inspection, implementing a new data management system, or responding to an audit finding, this checklist gives you a clear, structured starting point for assessing and improving your ALCOA+ compliance posture.
Related resources
Looking to go deeper on ALCOA+ and data integrity compliance?
- → ALCOA & ALCOA+ Principles: The Complete Guide — Everything you need to know about each principle, with real-world examples
- → 21 CFR Part 11 Compliance Checklist — FDA electronic records and signatures compliance
- → AuditSafe — 21 CFR Part 11 & ALCOA+ compliance software — Automate compliance across any existing lab system