Electronic records and signaturesAI-powered

Signed records that show who, when and what it meant.

Your team signs and corrects records with who, when and what it meant kept.

Start your free trial See it step by step

7-day free trial, no card required. Electronic signatures are in Professional and Enterprise. Every plan can view the audit log.

Clear signatures.
Each signature shows the signer, date and time, and its meaning, such as reviewed or approved.
Corrections kept.
Audit history keeps the original value, who changed it, when and, where required, why.
Validation support.
V5 validation evidence supports your team's own validation for its intended use.

See it work

Follow one signed record

An analyst corrects a transcription error on a lab result, and a reviewer signs it. Four stages, from scope to validation.

Result S-3307-02

One signed record, with its history in view

Try it: correct the entry with a reason, then sign it.

Moisture4.8 %

Entered byJ. Ortiz · 09:12

Not yet signed.

Audit history

09:12 · J. Ortiz entered 4.8 %
09:40 · J. Ortiz changed 4.8 → 4.3 % · reason: transcription
10:04 · A. Patel signed · Reviewed

Signature rules are set up by your team; your validation decides how they meet your Part 11 obligations.

Explore the details: every stage, with limits and set-up notes

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

Step 1 of 4

Signature set-up

Configured by Quality

Records in scopeLab results, batch records, documents
MeaningsReviewed · Approved · Released
Who may signBy role and permission
Re-enter credentialsAt each signing

Scope and meanings follow your procedures and intended use.

You decide what is in scope

Your quality team decides which records and signatures are in scope for your intended use.
Signature meanings and who may sign are set to match your procedures and roles.

Electronic signatures are Professional and Enterprise.

Also on this record

Decided by: Your quality team

Each signing asks the signer to confirm their identity.

Roles: Roles and permissions control who can sign which records.

Free buyer guide · 18 pages

Electronic Records & Inspection Readiness Buyer Guide

For quality, regulatory, validation and IT teams evaluating electronic records, signatures and inspection readiness.

1See what a signature must show.
2Check corrections keep the original.
3Know where Part 11 applies.

Get the guide

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Where it fits

Signatures wherever records need them

The same signing and history apply to documents, lab results, deviations and release decisions.

Document control Lab & QC QC release

What's included

Everything in this feature

What electronic records and signatures include, and which plan each item needs. Compare plans

Signatures and history

Records you can stand behind.

Electronic signatures · Tamper-evident audit trail · Audit log (view)

Explore records

Electronic signaturesProfessional and Enterprise
Name, date and time, and meaning, designed for 21 CFR Part 11.
Tamper-evident audit trailProfessional and Enterprise
Designed for ALCOA+ data integrity.
Audit log (view)
Who changed what and when.
Audit-trail explainerProfessional and Enterprise
Plain-English answers from recorded history.
Audit-readiness scoringEnterprise
Live readiness index across Part 11, GxP and ISO areas.

V5 supports electronic signing, audit history and validation evidence. 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.

Explore