ALCOA+ · MHRA · FDA · PIC/S PI 041
Data integrity software that supports ALCOA+ records.
Records carry who, what and when, with audit trail and signatures, so reviewers can check them.
Attributable by Design
Every write is bound to a named, authenticated user.
Contemporaneous Entry Enforced
Records open at the point of activity on the workstation, tablet or scanner — retrospective entries require a justified late-entry workflow, not a…
Original data captured at source
Instrument raw files (HPLC, GC, dissolution, balances) captured into V5 with checksums; the raw file is the original, the report is a derived view.
What goes wrong today3 common problems
Shared Logins and Delayed Entries
Operators write on paper first, someone types it in later, under a shared account — every ALCOA+ letter fails at once.
Audit trails are optional or disabled
The system supports audit trails but they're off, filtered, or overwritten — inspectors ask for the raw log and there isn't one.
Original Records Live on Instruments
The chromatogram is the original, the printout is a copy — but nobody knows where the original files are or whether they've been re-processed.
Everything V5 does here5 capabilities
Attributable by Design
Every write is bound to a named, authenticated user. No shared accounts. E-signatures capture meaning, name, timestamp and reason under 21 CFR Part 11.
Contemporaneous Entry Enforced
Records open at the point of activity on the workstation, tablet or scanner — retrospective entries require a justified late-entry workflow, not a keyboard.
Original data captured at source
Instrument raw files (HPLC, GC, dissolution, balances) captured into V5 with checksums; the raw file is the original, the report is a derived view.
Audit trail is unbroken and reviewable
Every create, update, delete, e-sign, override and role change is logged, tamper-evident, and reviewable — with periodic audit-trail review scheduled and evidenced.
Data Lifecycle Governed End-to-End
Retention, archival, restoration test, migration and legal hold are workflow-driven with objective evidence for every step.
How it works, step by step4 steps
DI in V5 is a property, not a feature.
- Roles and Reasons. Roles, permitted actions and reasons-for-action configured.
- Every write is attributable. User, time, reason captured unconditionally.
- Second-Person Review Records. Reviewer identity and rationale captured.
- Signed Export. Point-in-time record set with cryptographic signature.
What to look for when choosing
DI is architectural, not procedural. Any system that lets you 'turn off' the audit trail has already failed.
Structural ALCOA+
ALCOA+ enforced by the append-only, attributable record engine.
No Admin Override on Audit Trail
Can 'admin' edit history? No admin override. Trail is append-only for every role.
Dynamic Data Preserved
Is dynamic data (spectra, chromatograms) preserved with the record? Dynamic data attached in original form with metadata.
Second-Person Review Evidence
Is second-person review a first-class record? Second-person review captured as its own record with rationale.
Meta-Data Completeness
Are user, time, reason and object captured on every action? Meta captured unconditionally on every write.
V5 Compared with Other Approaches
DI approaches.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Append-only trail | No | Config | Architectural |
| Admin override | N/A | Sometimes | None |
| Dynamic data preservation | PDF only | Attach | Original preserved |
| Second-person review record | Signature only | Optional | First-class record |
Regulations this supportsYour quality team stays responsible for compliance
DI guidance and V5's answer.
MHRA GXP Data Integrity Guidance
Same controls across paper-replacement and electronic records.
FDA Data Integrity and Compliance With Drug CGMP
Completeness/consistency/accuracy enforced by write path.
PIC/S PI 041
PI 041 expectations reflected in configuration and evidence.
21 CFR Part 11 §11.10(e)
Native and unconditional.
Standards Referenced
- MHRA 'GXP' Data Integrity Guidance (March 2018)
- FDA Data Integrity and Compliance With Drug CGMP (December 2018)
- PIC/S PI 041-1 (Good Practices for Data Management and Integrity, 2021)
- 21 CFR Part 11 (electronic records & signatures)
- EU GMP Annex 11 (computerised systems)
- WHO TRS 1033 Annex 4 (Data Integrity, 2021)
Common questions3 answers
- How does V5 handle audit trail review at scale?
- Audit-trail review is a scheduled, filtered workflow — reviewers see exceptions (overrides, deletes, out-of-hours entries), not every keystroke. Coverage is evidenced per system, per period.
- What about legacy instruments without user accounts?
- V5 pairs shared-instrument workstations with a user-attribution layer: session login binds subsequent captures to the analyst, and the raw file plus session record together satisfy attributable.
- Does V5 pass a PIC/S PI 041 inspection?
- Yes — the control map to PI 041 sections 8 through 16 is available as a downloadable evidence pack, with system evidence linked per control.