04

Data Integrity

We ensure your regulated data is trustworthy — from record to decision.

ALCOA+Gap assessmentAudit trailRemediation

Data integrity ensures regulated information is Attributable, Legible, Contemporaneous, Original and Accurate — plus Complete, Consistent, Enduring and Available (ALCOA+), from record to decision.

We assess the data lifecycle — generation, processing, review, retention and disposal — in systems and on paper, identifying gaps and risks.

We turn findings into a risk-prioritized remediation plan, with audit trail governance, access control and review by exception.

Deliverables cycle

Data Integrity Gap Assessment

ALCOA+ diagnosis of systems and processes, revealing gaps and risks.

Data Lifecycle Map

Flow of critical data, from record to archiving, exposing points of vulnerability.

Remediation Plan

Risk-prioritized actions with owners and defined deadlines.

Audit Trail Governance

Configuration and review of audit trails and review by exception.

Access & Profile Control

Segregation of duties and periodic access review.

How we run it

01

Diagnose

ALCOA+ gap assessment and data map.

02

Prioritize

Risk and criticality classification.

03

Remediate

Technical and procedural controls.

04

Sustain

Continuous governance and review by exception.

Applicable standards

ALCOA+MHRA Data IntegrityFDA 21 CFR Part 11WHO / PIC/SEU Annex 11

Frequently asked questions

What is ALCOA+?

A set of attributes trustworthy data must have: Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring and Available.

Does it apply to paper data?

Yes. Data integrity covers hybrid and paper records, not just electronic systems.

Where to start?

With the gap assessment: it reveals where the risks are before investing in remediation.