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Why it matters: data integrity failures lead to repeat observations, recalls, and trust erosion.

What it is: the alignment of ALCOA+ principles—attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available—with your electronic quality records.
Problem solved: prevents lost, altered, or inaccessible evidence that investigators blame on sloppy controls.
Where it plays out: audit trails, batch records, training logs, deviations, CAPA, change control, and document capture.

Data integrity is the practical test regulators use to confirm your quality records are genuinely trustworthy.

Regulatory Requirements

Regulators demand data integrity under multiple frameworks:

FDA 21 CFR Part 11 states electronic records must be trustworthy and reliable.
EU GMP Annex 11 and Annex 11 guidance define expectations for tamper-proof systems.
MHRA GxP data integrity guidance and PIC/S requirements highlight ALCOA+ behavior.
Guidance from ICH, WHO, and global inspectors reinforce that data must be attributable, legible, contemporaneous, original, and accurate.

Regulatory callout: inspectors expect your systems to prevent unauthorized changes, provide readable history, and maintain records for the entire retention period.

Inspection Perspective

Inspectors look for data integrity everywhere:

Do audit trails cover critical entries and show meaningful rationales?
Are there controls preventing shared IDs and unauthorized edits?
Can electronic records be exported, read, and reconstructed easily?
Are policies, training, and review schedules keeping the principles front of mind?
Does the site clearly divide human processes from technical safeguards?

Inspector insight: weak investigations or hidden spreadsheets raise immediate data integrity concerns.

Common Failures

Common data integrity failings are often systemic:

Records with no attribution or with shared logins.
Audit trails suppressed, disabled, or dumping meaningless entries.
Manual overrides without documented justification.
System migrations without reconciliation.
Procedures that treat data integrity as an IT checkbox.

Failure callout: once regulators suspect data manipulation, they probe every related log for similar patterns.

eQMS Enablement

A modern eQMS keeps data integrity visible and defensible:

Enforces role-based authentication and prevents shared accounts.
Protects system configuration so audit trails can’t be deleted or backdated.
Links records, approvals, and follow-up actions so investigators see the full context.
Provides exports and reports that match ALCOA+ expectations.

Complere embeds data integrity across deviations, training, CAPA, and change control so every record carries retraceable provenance.

Related Terms

Glossary FAQs

What makes a data integrity program inspection-ready?

Data integrity programs enforce ALCOA+ principles—attributability, legibility, contemporaneous entries, original records, accuracy, completeness, consistency, endurance, and availability—across every electronic record.

How does Complere enforce ALCOA+ across quality records?

Complere enforces traceability, audit trail review, and tamper resistance across deviations, training, documents, and CAPA so data integrity is visible.

What do inspectors check when assessing data integrity?

Inspectors review access controls, audit trail review procedures, records retention, and evidence that data cannot be manipulated without detection.

Which guides reference data integrity principles?

FDA 21 CFR Part 11, EU GMP Annex 11, MHRA GxP data integrity guidance, PIC/S, and WHO guidelines reference ALCOA+ behaviors.

How does ALCOA+ differ from general IT backup practices?

IT backups protect images; ALCOA+ insists on controlled entry, audit trails, role-based security, and retrievable evidence tied to GMP intent.

Strengthen record trust and inspection defensibility

Complere helps regulated teams manage GMP records with stronger traceability, clearer accountability, and more reliable access to the record history inspectors often want to see.

Audit ready | Stronger record trust | Clearer traceability

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Data Integrity