General

Data Integrity(DI)

The completeness, consistency, and accuracy of data throughout its lifecycle, following ALCOA+ principles.

Usage Examples

The audit identified data integrity concerns with HPLC records.
ALCOA+ principles were incorporated into training.
Audit trail review confirmed data integrity.

What is DI?

Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire lifecycle. In pharmaceutical manufacturing and clinical research, data integrity is a critical GxP requirement.

ALCOA+ principles define data integrity requirements: Attributable (who performed action), Legible (readable), Contemporaneous (recorded at time of activity), Original (first capture), Accurate (no errors), plus Complete, Consistent, Enduring, and Available.

Data integrity failures have led to significant FDA warning letters and consent decrees. Electronic systems require appropriate controls per 21 CFR Part 11 and EU Annex 11.

Regulatory Context

This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 11, EU ANNEX 11, FDA DATA INTEGRITY GUIDANCE.

FDAICHHealth Canada

When This Matters

The audit identified data integrity concerns with HPLC records.
ALCOA+ principles were incorporated into training.
Audit trail review confirmed data integrity.

Common Mistakes

Relying on generic terminology without mapping to the active jurisdiction context.
Skipping cross-links between terms, tools, and active regulatory references.
Failing to maintain a single source of truth for regulatory definitions internally.

Related Regulations

21 CFR 11EU ANNEX 11FDA DATA INTEGRITY GUIDANCE

Frequently Asked Questions

ALCOA+ expands on ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) by adding Complete, Consistent, Enduring, and Available as additional data integrity requirements.

Part 11 establishes requirements for electronic records and signatures, including audit trails, access controls, and system validation, which support data integrity for electronic systems.