Insight Brief · Data Integrity

ALCOA+ in practice:
controls, not slogans.

ALCOA+ becomes meaningful only when translated into controls, roles, reviews and evidence. Inspectors test whether data integrity is actively governed or passively assumed, not just documented.

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What This Covers

Translating each principle
into operating controls.

Each ALCOA+ attribute maps to a set of controls that must be demonstrably operating. The following four groupings cover the full model from attribution through to long-term availability.

AttributableUnique user IDs, controlled access, signature governance. Every action on a regulated record must be traceable to an individual, not a role or shared account.

Legible & ContemporaneousReadable records in controlled formats, time-stamped at the point of creation. Controlled time sources where relevant to the system's scope.

Original & AccurateSource data governance, interface controls and auditability. Review controls, error handling and deviation linkage ensure accuracy is actively maintained.

Complete, Consistent, Enduring, AvailableRetention controls, backup and restore evidence, and periodic review that ensures records remain retrievable and complete throughout the required period.

Evidence Pack

Evidence that creates
inspection confidence.

A well-constructed evidence set makes the ALCOA+ narrative coherent. Inspectors want proof of operation, not just statements of intent.

Data lifecycle mapRisk-based mapping of records, data flows, retention requirements and control responsibilities across each regulated system.

Audit trail review outputsReview strategy, evidence of periodic review, anomaly handling records and documented rationale for scope and frequency.

Access review recordsPeriodic access recertification, privileged access governance and documented leaver/joiner/mover controls with review outputs.

Deviation and CAPA integrationLinkage of data integrity events into the formal deviation and CAPA process, with root cause analysis and corrective actions.

Common Questions

Frequently asked.

Do we need a lifecycle map for every system?

Risk-based, not universal

For critical systems and high-impact records, lifecycle mapping is a strong and defensible foundation. For lower-risk systems, a summary assessment aligned to intended use may be proportionate.

How do we prove data is 'enduring' and 'available'?

Retention controls and restore evidence

Through documented retention controls, backup and restore testing evidence, and governance that ensures records remain retrievable throughout the required retention period.

What is the quickest win for data integrity?

Audit trail review with evidence

Implement effective audit trail review aligned to record impact, with retained outputs and clear escalation paths. This is one of the most visible demonstrations of active governance.

Data integrity concerns?
Let’s look at the evidence.

Book a call to discuss your data landscape. We’ll identify the gaps that matter and build a control model that holds up under inspection.

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ALCOA+ in practice:controls, not slogans.

Translating each principleinto operating controls.

Evidence that createsinspection confidence.

Frequently asked.

Data integrity concerns?Let’s look at the evidence.

Explore further.

ALCOA+ in practice:
controls, not slogans.

Translating each principle
into operating controls.

Evidence that creates
inspection confidence.

Data integrity concerns?
Let’s look at the evidence.