Document control software — every SOP, signed, trained and current.
Every SOP, work instruction, form and specification in V5 has a controlled lifecycle: draft → review → e-sign approval → effective → training assignment → periodic review. Operators only ever see the current effective version on the kiosk.
What breaks without this.
Operators read superseded SOPs
Paper SOPs in binders go stale the moment a new revision is approved — and the line keeps running on the old version.
Training doesn't follow the SOP change
When an SOP changes, nobody knows who needs to be retrained — and the next audit finds operators trained on rev 3 still running rev 4.
Approvals can't survive a Part 11 audit
Email-based SOP approvals don't carry the meaning of the signature, the time, or the audit trail FDA expects.
Records-by-execution. Compliance, by design.
Controlled lifecycle on every document
Draft → review → e-sign approval → effective → periodic review. Every transition is captured with user, time, reason and Part 11 e-signature.
Kiosk only shows the effective version
Operators see the current revision tied to the job. Superseded versions are physically inaccessible on the floor.
Training assignments triggered by revision
A new revision automatically generates retraining tasks for every operator on that SOP — with kiosk lockout until they complete it.
Change history with redline diff
Every revision shows what changed, who approved it, why, and which records reference it.
Periodic review forcing function
SOPs flag for review at their defined interval (typically 24 months). Overdue documents trigger a CAPA.
Proof points
- Part 11 e-signed approval workflow
- Kiosk-enforced current revision
- Retraining auto-triggered by revision change
- Redline diff and full change history on every doc
Built to satisfy
- 21 CFR 211.100 (Written procedures)
- 21 CFR 211.180 (Records retention)
- 21 CFR 820.40 (Document controls)
- 21 CFR Part 11 (Electronic records and signatures)
- EU GMP Chapter 4 (Documentation)
- ISO 13485 §4.2 (Document requirements)
- ISO 9001 §7.5 (Documented information)
Frequently asked questions
Is V5 a Part 11 compliant document control system?+
Yes — every approval, revision and read-receipt uses Part 11 e-signatures with meaning, user, time and reason captured in an immutable audit trail.
How does training stay in sync with SOP revisions?+
A new effective revision automatically assigns retraining to everyone on that SOP. Operators are locked out on the kiosk until they've signed off the new revision.
Can we import existing SOPs?+
Yes — PDF and Word imports are converted into V5 controlled documents with version 1.0 set at import, then put through your normal review/approval cycle.
How fast can we deploy?+
Document control onboarding is typically 7 days including SOP import and lifecycle configuration.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.