Document controlAI-powered

One version in force. Every change on record.

Draft the next revision while the current one stays in use, approve it under your route, and keep the history.

Start your free trial Follow one document change

7-day free trial, no card required. Document control, electronic signatures and training records are in Professional and Enterprise.

One version in use.
The shop-floor screens show the revision in force; drafts stay out of the way until they become effective.
Approvals you can show.
Reviewers and approvers sign under your route, with the reason for change kept on the record.
Training follows the change.
A new revision can set who needs to read or be trained on it, so the change reaches people.

See it work

Follow one document change

WI-PK-12 · raised from CAPA-0390

Compare, then approve a new revision

Try it: show the changes between rev 6 and draft rev 7, then sign in order. Rev 7 takes effect only when the approver signs.

Rev 6 → draft rev 7

1Load cartons onto infeed~~Load cartons onto infeed~~
Load cartons onto infeedChanged
2Set sealer temperature per spec~~Set sealer temperature per spec~~
Set sealer temperature per specChanged
3Run first carton~~Run first carton~~
Run first cartonChanged
4—
Confirm seal check after changeoverAdded
5Record line start~~Record line start~~
Record line startChanged
6Photo of first sealed carton~~Inspect first sealed carton~~
Photo of first sealed cartonChanged

Approval trail

Reviewed · Production managerWaiting
Reviewed · QA specialist—
Approved · Quality manager—

Rev 6 stays in force until rev 7 is approved.Rev 7 in force · rev 6 superseded and kept in history · training due for 2 people.

Worked example. Each signature records its meaning, signer, date and time.

How document control works: change, approval, effective date and history

Tap a step below to see what happens.Choose a step below to see what happens.

Step 1 of 5

Change request CR-0218

WI-PK-12 · Carton sealing

CurrentRev 6 · in force
ReasonSeal check missed after changeover
Raised fromCAPA-0390
OwnerPackaging lead · M. Duarte

The change links back to the quality record that raised it.

A change starts with a reason

Raise a change with its reason, often from a CAPA, a deviation or a periodic review.
The change links back to the record that raised it, so reviewers see why.

Document control is Professional and Enterprise.

Also on this record

Raised: 2 Oct · 11:05

Rev 6 stays the version in use while the change is worked on.

Document types: SOPs, work instructions and other controlled documents your procedures define.
Bringing documents in: AI document intake can read existing PDFs into drafts for a person to check. Professional and Enterprise.

Free buyer guide · 12 pages

Quality Management Buyer Guide

For quality, regulatory and operations teams choosing quality management software.

1Link each revision to the training it needs.
2Keep changes tied to the CAPA or review that raised them.
3Score suppliers using one of your own SOPs.

Get the quality management guide

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Where it fits

Documents connected to the work

Changes link to the CAPA or review that raised them, the shop-floor screens show the version in force, and training follows the revision.

Periodic review Skills matrix Part 11 signatures

What's included

Everything in this feature

What document control includes, and which plan each item needs. Compare plans

Revisions and approval

Draft, sign and make effective without two versions in use.

Document control · Electronic signatures · Audit log (view)

Explore revisions

Document controlProfessional and Enterprise
SOPs, work instructions and controlled revisions with history.
Electronic signaturesProfessional and Enterprise
Signatures with meaning, designed for 21 CFR Part 11.
Audit log (view)
Who changed what and when.
AI document intakeProfessional and Enterprise
Reads existing documents into drafts for a person to check.

People and follow-through

Changes reach the people who do the work.

Training and competence · Skills matrix · CAPA and deviations

Explore training

Training and competenceProfessional and Enterprise
Training per document revision.
Skills matrixEnterprise
People-by-task view of who is qualified and who is due.
CAPA and deviationsProfessional and Enterprise
Changes linked to the quality record that raised them.
Routed notificationsProfessional and Enterprise
Email and SMS for pending approvals, with escalation.

People draft, review and approve under your procedures. V5 keeps the versions, signatures and history; it does not by itself make you compliant or validated.

V5 AI

AI that sees it coming

It predicts and flags. Fixed rules decide. People sign.

AI for documents and training

Know who needs training next.

Upcoming revisions show who will be due, before the effective date.

See V5 AI AI drafts and flags. A qualified person reviews and signs.

Questions

Straight answers.

What buyers ask us first about Documents & Training.

Can V5 stop an untrained person starting a step?
It can when you configure training checks at the step (Professional and Enterprise). People still decide who is qualified.
Is there a full skills matrix?
The full skills matrix with competencies and refresher reminders is an Enterprise feature.
How do new procedure revisions reach the floor?
A revision is approved with an effective date. Training can be assigned before that date, and the kiosk shows the approved revision once it takes effect.

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