Data Integrity
ALCOA+ enforced across GxP systems — because every quality claim rests on it.
What a domain score is not
A domain is one of the axes SPEQ’s assessment scores, on SPEQ’s own five-stage progression. It is a labelled synthesis, not the FDA’s Quality Management Maturity rating, and a score here is a self-assessment — nobody but you has rated your organization.
Every quality claim ultimately rests on data integrity: a result is only as trustworthy as the record and metadata behind it. Disabled audit trails, shared logins, and review of the printed result without the audit trail are precisely the observations that escalate to warning letters and import alerts — this domain is the foundation the whole system stands on.
Maturity in data integrity is not stronger controls; it is the removal of the reasons people work around them. A low-maturity operation trains on ALCOA+, audits records and finds the same weaknesses; a mature one designs the work so the compliant path is the easy one — unique accounts because shared ones are not needed, contemporaneous entry because the record is where the work is, audit trails reviewed because review is built into release rather than scheduled separately. The governing insight is that most data-integrity findings are process design problems wearing a behaviour costume.
- Remove shared accounts by removing what made them necessary — licences, terminal access, the speed of logging in — rather than by prohibiting them again.
- Build audit-trail review into the review that already happens at release, instead of creating a separate periodic activity that competes for time.
- Look for the workaround, not the violation: a paper note transcribed later, a spreadsheet beside the validated system, a form that cannot be completed as written. Each is a design signal.
- Make the escalation of a record weakness safe and routine, because the alternative is that it gets resolved locally and invisibly.
The presence of unofficial records — notebooks, spreadsheets, photographs of screens — is the leading indicator, and finding them requires looking rather than asking. Then: whether audit-trail review has ever generated a finding, since a review that never finds anything is not being performed as described; and the time between an observation being made and being recorded.
The observable behaviours that place a site at each level — what a practitioner or inspector would actually see — and the concrete move that carries it to the next.
- ·Shared logins and uncontrolled spreadsheets are common
- ·Audit trails are off, incomplete, or never reviewed
- ·Paper records show gaps, back-dating, or missing signatures
TO ADVANCE →Establish ALCOA+ awareness and close the obvious gaps: unique logins, audit trails on, controlled records.
- ·Audit trails are enabled but not systematically reviewed
- ·Access control is partial; some systems still shared
- ·Data-integrity depends on individuals doing the right thing
TO ADVANCE →Make audit-trail review routine and risk-based, and extend controls across all critical systems.
- ·Risk-based audit-trail review is scheduled and evidenced
- ·Access, time-sync, and change controls are enforced
- ·A data-integrity risk assessment covers the record lifecycle
TO ADVANCE →Trend audit-trail-review findings and data-integrity events so systemic weaknesses surface.
- ·Audit-trail-review findings are trended and drive fixes
- ·Data-integrity events feed CAPA and system improvement
- ·Metrics show the state of control across systems
TO ADVANCE →Design integrity in — reduce the manual review burden with better system controls.
- ·Controls make integrity failures hard by design, not by vigilance
- ·Automated exception review focuses human attention on real risk
- ·Integrity is a property of the systems, not the people
- An audit trail for a critical GxP record showing it is reviewed, with the review documented
- Evidence of ALCOA+ controls on a specific system (access control, no shared logins, time sync)
- A data-integrity risk assessment covering the record lifecycle for a key process
Want the specific artifacts that move your score up? The Comprehensive assessment turns your domain scores into a prioritised, personalised remediation plan.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How are ALCOA+ data-integrity principles enforced across GxP systems?
Data integrity is not formally addressed
A policy exists, but controls vary by system and area
DI governance with audit trails, review, and access controls across GxP systems
DI risk assessments, audit-trail review by exception, and periodic DI audits
Data integrity by design: continuous automated DI monitoring, predictive risk detection, and audit-by-exception across all GxP systems
How are computerised-system audit trails reviewed?
Audit trails are available but rarely reviewed
Audit trails are reviewed only during investigations
Routine risk-based audit-trail review with a documented cadence
Audit-trail review by exception, supported by tooling and metrics
Automated continuous audit-trail surveillance with anomaly detection and predictive exception management
- ›Audit trails disabled, not configured, or never reviewed — the result is reviewed but not the metadata behind it.
- ›Shared or generic logins; inadequate access control and segregation of duties.
- ›Ability to delete or overwrite original records without trace; hybrid systems where paper is treated as the "original".
- ›No data-integrity risk assessment or governance across the GxP system landscape.
Recent FDA recalls whose reason SPEQ maps to this domain — a SPEQ editorial interpretation of the recall reason, not an official FDA classification.