Attribution
Every action is user-attributed
All changes, approvals, and sign-offs capture the unique user identity, role, and timestamp — eliminating the 'shared login' risk that inspectors frequently flag.
Compliance Topic
Data Integrity & Audit Trails
Attributable, legible, contemporaneous, original, and accurate — the ALCOA+ framework built into every Complere workflow.
Data integrity failures are among the most common findings in FDA Warning Letters, EU GMP inspections, and WHO audits. Complere addresses the ALCOA+ framework at the platform level, embedding attribution, timestamping, original record preservation, and controlled access into every quality workflow — so evidence stays inspection-ready without requiring additional manual checks.
Key Benefits
How this module improves quality operations, reduces compliance risk, and supports inspection readiness for regulated teams.
Contemporaneous
Records are captured at the point of action
Complere records activity in real time. Backdating and after-the-fact edits are controlled and tracked, preserving original record integrity.
Inspection Confidence
Evidence retrieval in minutes, not hours
Linked audit trails, exportable history, and contextual record views mean quality teams can respond to inspector requests without reconstructing evidence from multiple systems.
Workflow Overview
How Complere supports the workflow
Each step in this workflow is supported by governed records, electronic signatures, and a full audit trail — so quality operations stay traceable and inspection-ready.
01
Action is performed
A user completes a quality workflow step — drafting a document, submitting a CAPA, closing an audit finding.
02
Attribution is recorded
The system binds the action to the user's identity, role, session, and timestamp automatically.
03
History stays linked to the record
The audit trail is accessible directly from the quality record — not in a separate admin log.
04
Evidence is exported for inspection
Quality teams can export full audit trail histories in structured formats for inspector review.
Platform Capabilities
The specific controls, features, and workflow functions built into this module to support your quality and compliance objectives.
Attributable
User-bound audit trail for every record
Identity, role, timestamp, IP context, and action type are captured on every quality event — approval, revision, rejection, or status change.
Legible
Readable history alongside the record
Old and new field values, reason-for-change notes, and linked workflow context appear together — not buried in a separate system log.
Original
Protected original record state
Approved records are locked. Revision creates a new controlled version; the original is retained and accessible throughout the lifecycle.
Accurate & Complete
No gaps in the activity chain
Complere captures the complete workflow history including draft, review, rejection, resubmission, and approval — not just the final approved state.
ALCOA+ Principles in Complere
How Complere addresses each of the nine ALCOA+ data integrity principles at the platform level — not as a configuration option, but as a baseline behaviour.
A
Attributable
Every quality action is bound to the user who performed it — name, role, timestamp, and IP context are captured automatically.
- No shared logins
- User-bound approval signatures
- Re-authentication for critical actions
L
Legible
Records are readable now and throughout the retention period. Field changes show old and new values alongside reason-for-change notes.
- Human-readable audit entries
- Old/new value diff on every edit
- Reason-for-change captured in-workflow
C
Contemporaneous
Quality records are created and timestamped at the point of action — not reconstructed after the fact or backdated.
- Server-side UTC timestamps
- No backdating of records
- Real-time capture enforced by workflow
O
Original
The first approved state of a record is preserved. Revisions create new controlled versions; originals remain accessible.
- Version-locked originals
- Controlled revision creates new record
- Permanent retention of prior versions
A
Accurate
Records reflect what actually happened. Complere workflow controls prevent unauthorized edits after approval and flag data anomalies.
- Post-approval edit controls
- Audit trail for every change attempt
- Deviation flagging on out-of-norm entries
+
Complete, Consistent, Enduring, Available
Complere captures the full workflow history — draft through approval — and keeps records accessible over the complete retention period.
- Full lifecycle captured, not just final state
- Consistent record format across modules
- Exportable for inspector review at any time
See how Complere addresses ALCOA+ at every quality workflow step
Data integrity is not a feature add-on in Complere — it is part of the platform architecture. Schedule a demo to see attribution, trail depth, and retrieval in your context.