ALCOA+ Data Integrity

ALCOA+ principles

ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) is the data integrity framework applied by major regulatory authorities.

Data integrity assessment

A data integrity assessment reviews the GxP systems, the operating routines, and the data flows against the ALCOA+ principles. The assessment identifies gaps, classifies them by severity, and prioritizes them for remediation.

Remediation roadmap

The remediation roadmap defines the corrective actions, the preventive actions, the responsible owners, the dates, and the evidence of completion.

Operating routine

The operating routine establishes the daily, weekly, monthly, and quarterly practices that maintain data integrity over time.

How to use this page

Use this ALCOA+ Data Integrity page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.

Evidence to prepare

For ALCOA+ Data Integrity, prepare the records, owners, risks and decision criteria linked to alcoa+ principles, data integrity assessment, remediation roadmap, operating routine. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.

Frequently asked questions