Data integrity software that makes ALCOA+ the default, not a policy.
V5 enforces Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available — at the record level. Audit trails are unbroken, e-signatures bind to the acting user, instrument data is captured at source, and the 483 line about 'unable to reconstruct' never appears.
What breaks without this.
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.
Records-by-execution. Compliance, by design.
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.
What to look for when you're buying.
DI is architectural, not procedural. Any system that lets you 'turn off' the audit trail has already failed.
Structural ALCOA+
What it tests: Are Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available guaranteed by design?
Why it matters: Procedural DI drifts.
V5: ALCOA+ enforced by the append-only, attributable record engine.
No admin override on audit trail
What it tests: Can 'admin' edit history?
Why it matters: This single flag decides your inspection posture.
V5: No admin override. Trail is append-only for every role.
Dynamic data preserved
What it tests: Is dynamic data (spectra, chromatograms) preserved with the record?
Why it matters: Static PDFs of dynamic data are a finding.
V5: Dynamic data attached in original form with metadata.
Second-person review evidence
What it tests: Is second-person review a first-class record?
Why it matters: MHRA requires evidence, not signature only.
V5: Second-person review captured as its own record with rationale.
Meta-data completeness
What it tests: Are user, time, reason and object captured on every action?
Why it matters: Missing metadata = missing ALCOA+.
V5: Meta captured unconditionally on every write.
Spreadsheet vs legacy QMS vs V5.
DI approaches.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| 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 |
The clauses, verbatim — and how V5 answers each.
DI guidance and V5's answer.
Data integrity requirements apply equally to paper and electronic data.
V5: Same controls across paper-replacement and electronic records.
For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data.
V5: Completeness/consistency/accuracy enforced by write path.
Good practices for data management and integrity in regulated GMP/GDP environments.
V5: PI 041 expectations reflected in configuration and evidence.
Use of secure, computer-generated, time-stamped audit trails...
V5: Native and unconditional.
Step by step on the floor.
DI in V5 is a property, not a feature.
- 1Configure
Roles and reasons
Roles, permitted actions and reasons-for-action configured.
- 2Operate
Every write is attributable
User, time, reason captured unconditionally.
- 3Review
Second-person review records
Reviewer identity and rationale captured.
- 4Audit
Signed export
Point-in-time record set with cryptographic signature.
The math, with the assumptions visible.
DI ROI is measured in avoided remediation.
DI-driven remediation cost
Structural DI removes the class.
DI-driven inspection findings
Architecture.
For sites at DI risk, this is the biggest single ROI on the platform.
What changed on the floor.
Setting
A generics manufacturer post-MHRA DI observation.
Before
Legacy system allowed admin edits; observation triggered remediation program.
After
V5 architecture closed the observation class; follow-up inspection observed no DI issues.
Proof points
- Every ALCOA+ letter mapped to a system control, not an SOP paragraph
- Audit trail review is a scheduled workflow, not an afterthought
- Instrument raw data captured — the copy is the derivative, not the record
- 483 / warning-letter data-integrity patterns designed out
Built to satisfy
- 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)
Related on V5
Frequently asked questions
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.
See V5 on your own line.
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