Check you can show the evidence, before an auditor asks.
Check, question by question, that you can show the evidence before an auditor asks.
7-day free trial, no card required. The evidence it checks (signatures, documents, training, deviations, supplier approval) is mostly in Professional and Enterprise.
Common audit questions.
Work through the questions auditors commonly ask and find the record for each.
Honest ratings.
Your team rates found, partly found or not found; it is a self-check, not a score.
Gaps become actions.
Every gap becomes an action with an owner and a date.
Follow one self-check
A customer audit is six weeks away. The quality manager works through six evidence questions. Four stages, from questions to owned actions.
Three questions, honest answers
Try it: answer each question to see the areas to work on.
Can you show training for every operator on line 2?
Answers are your team's own judgement against records. There is no compliance score.
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
- 1Who signed, and what it meant?
- 2Revision in force that day?
- 3Was the operator trained on it?
- 4What happened to this deviation?
Use your last audits' questions, or the six in our checklist.
Start from what auditors actually ask
- Start from the questions your last audits asked, or the six in our checklist.
- They cover signed records, audit history, documents, training, deviations and supplier approval.
A self-check aid. It is not a compliance score or a certification.
More on questions: full record and set-up
Also on this record
- 5–6
- Audit history · supplier approval
Your procedure decides how often you repeat the self-check.
- Your questions
- Add questions specific to your customers or regulators; the checklist is a starting point.
Electronic Records & Inspection Readiness Buyer Guide
For quality, regulatory, validation and IT teams evaluating electronic records, signatures and inspection readiness. Use it with or without V5.
- 1Check readiness area by area.
- 2Find gaps without a score.
- 3Turn gaps into owned actions.
See what's inside
- Which rules apply to which records
- Record lifecycle, attribution and authority checks
- Signatures, corrections and audit trail
- Batch and device history records
- Review by exception and controlled release
- Risk-based validation and Enterprise IQ/OQ
- Audit readiness, inspection requests and floor audits
- Sharing records outside the company
- Evidence matrix, RACI, migration, demo scenarios and RFP
Chapters: why record questions go badly · which rules apply · record lifecycle · attribution and authority · electronic signatures · corrections and audit trail · batch and device history records · review and controlled release · validation and Enterprise IQ/OQ · audit readiness evidence map · inspection requests · floor audits · external sharing · evidence matrix, RACI and migration · demo scenarios and RFP · where V5 fits and sources.
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A self-check built on records you already keep
The evidence is the audit history, documents, signatures and quality records V5 keeps every day.
What's included
The records the self-check looks for, and which plan each needs. Compare plans
Evidence the check uses
Each question maps to records V5 keeps.
Audit log (view) · Electronic signatures · Document control
Explore evidence
Evidence the check uses
Each question maps to records V5 keeps.
Audit log (view) · Electronic signatures · Document control
- Audit log (view)Who changed what and when.
- Electronic signaturesProfessional and EnterpriseName, date and time, and meaning.
- Document controlProfessional and EnterpriseWhich revision was in force on a date.
- Training and competenceProfessional and EnterpriseWho was trained on which revision.
- Deviations and CAPAProfessional and EnterpriseEvents, investigations and actions.
- Supplier portalProfessional and EnterpriseSupplier documents against your specification.
- Readiness scoringEnterpriseSeparate live readiness index across Part 11, GxP and ISO areas.
Your team rates the evidence and decides what is enough. AI never rates your evidence.
Run the six questions against your own records.
Start your free trialOr (you can edit the question before sending) or .