V5 Ultimate
Inspection readiness

Know who fetches each record before the inspector asks.

Plan and practise who retrieves each record, and what they check before showing it.

Start your free trial See it step by step

7-day free trial, no card required. Batch records and audit log are in every plan. Documents, training, deviations and signatures are Professional and Enterprise.

Auditor in hair cover, mask, safety glasses and gloves holding a tablet while talking with a supervisor in the same protective clothing beside production equipment

  • A plan per request.

    For each kind of request, note where the record lives in V5 and who retrieves it.

  • Checked before shown.

    Retrievers confirm the right version, signatures and linked records first.

  • Practised, not hoped.

    Run practice requests on a real lot and fix the gaps you find.

Follow one practice run

Before an inspection, the head of QA runs a practice request on lot P-0218. Four stages.

Practice · lot P-0218

From request to an approved response

Try it: have each owner retrieve, then approve before it goes in the pack.

  • Batch record P-0218
    QA lead · Requested
  • Training for operators on line 2
    HR / training · Requested
  • Scale calibration certificate
    Maintenance · Requested
0 of 3 approved for the pack

Owners and approvers are your people; V5 finds the linked records.

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

Tap a step below to see what happens.

Step 1 of 4

Request plan
Head of QA
  • Batch recordReviewed version
  • Deviations and CAPAWith investigation
  • TrainingOn date of use
  • EquipmentOn date of use

Records not in V5 have a named location too.

List what inspectors usually ask for

  • List the records inspectors or auditors usually ask for.
  • For each, note where it lives in V5, or elsewhere if it isn't in V5.

An automated audit-pack export is not part of the verified product description.

More on requests: full record and set-up

Also on this record

Supplier approval
Status on date of receipt

Keep the plan as a controlled document if your procedure requires.

Not in V5
Your procedure says where the record is and who retrieves it.
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. Use it with or without V5.

  • 1Route each request to an owner.
  • 2Approve the response pack.
  • 3Rehearse with demo scenarios.
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.

Get the guide

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Guide page 17: demo scenarios and RFP questionsGuide page 13: inspection request to approved responseCover of the Electronic Records & Inspection Readiness Buyer Guide

A people plan on top of linked records

Audit readiness keeps records linked; this plan makes sure the right person can find and check them quickly.

Audit readinessSharing reportsSelf-assessment

What's included

Records a practice run draws on, and which plan each needs. Compare plans

Records and history

What retrievers fetch.

Batch reporting · Audit log (view) · Calibration

Explore inspection readiness
  • Batch reporting
    Batch records built from recorded data.
  • Audit log (view)
    Who changed what and when.
  • Calibration
    Status on date of use.
  • Document control and trainingProfessional and Enterprise
    Revision and training on date of use.
  • Deviations and CAPAProfessional and Enterprise
    Investigations and actions.
  • Electronic signaturesProfessional and Enterprise
    Name, date and time, and meaning.

V5 keeps records, history and signatures; your team and procedures establish readiness. No certification is claimed.

Try a practice run on one of your own lots.

Start your free trial

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