Regulations
8 min read
January 26, 2026
Data Integrity in eQMS and DMS - ALCOA+ Requirements
Dr Anna Kowalska
Quality & Compliance Director
Key Takeaways (TL;DR)
Executive Summary
ALCOA+ is the data integrity standard required by FDA and EMA
Audit trail must be immutable and automatically generated
Backup and disaster recovery are critical for business continuity
Data Integrity is one of the most critical aspects of electronic systems in life sciences. FDA and EMA pay special attention to ALCOA+ compliance during inspections. Every eQMS and DMS must ensure data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete, Consistent, Enduring, and Available.
Frequently Asked Questions (FAQ)
What does ALCOA+ stand for?
ALCOA+ is an acronym: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available.
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