V5 Ultimate
Electronic batch and device history records

The production record fills in as the work is done.

Batch and device history records build from what operators record at each step.

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7-day free trial, no card required. Regulated reports (BMR, eDHR, MMR, CoA) and electronic signatures are in Professional and Enterprise. Standard PDF reports are in every plan.

QA reviewer in hair cover, mask, glasses, white coat and gloves reading a record on a monitor beside a window onto an enclosed filling line, where operators in protective clothing work

  • Built as work happens.

    Materials, steps, checks and signatures fill the record from the work order and instructions in force.

  • Review by exception.

    Reviewers start from the exceptions instead of reading every line.

  • People decide release.

    A named reviewer signs the decision; V5 never releases a batch on its own.

Follow one batch record

Bulk lot B-6140 of a hand cream, from work order release to the reviewer's signature. Four stages; a device history record follows the same pattern.

Batch B-6140 · worked example

The batch record writes itself from the work—review starts with what stood out.

Text summary of this animation (7 steps)
  1. Record starts from the job. Releasing WO-6140 opens batch record B-6140 with product, quantity and instruction revision.
  2. Dispense adds itself. Nine dispensed materials and their lots arrive from the weighing station—nothing is retyped.
  3. Mixing recorded. The mixing step adds its time, speed and operator sign-off.
  4. Exception captured. The pH check records 6.9, above the 5.5–6.5 limit. It is kept as entered and highlighted; DEV-1301 is linked.
  5. Fill completes. Filling adds 3,190 units of 250 ml. The record is complete and goes to review, exceptions first.
  6. Reviewer opens evidence. The reviewer opens DEV-1301: pH adjusted and retested at 6.2, closed by quality.
  7. Review signed. The reviewer recorded the review with an electronic signature. Release stays a separate human decision.

Worked example. Batch and device history records build from what operators record at each step, and the printable batch report comes from the same data; every change carries an audit history. Electronic signatures are Professional and Enterprise. Software features do not by themselves validate your process or make a site compliant: your procedures, validation for intended use and every release decision stay with your people.

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.

  • 1Know what a full record holds.
  • 2Review exceptions, not every line.
  • 3People release the batch.
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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Guide page 10: review by exception and controlled releaseGuide page 9: batch and device history recordsCover of the Electronic Records & Inspection Readiness Buyer Guide

The record at the centre of execution and quality

Execution writes it, quality reviews it, release decides on it, and traceability reads from it.

MESQC release21 CFR Part 11

What's included

What the electronic record uses, and which plan each item needs. Compare plans

Record and review

Built as the work is done.

Work orders and shop-floor screens · Standard PDF reports · QA release queue

Explore batch records
  • Work orders and shop-floor screens
    Where entries are made.
  • Standard PDF reports
    Basic batch reporting.
  • QA release queue
    Records waiting for review.
  • Regulated reportsProfessional and Enterprise
    BMR, eDHR, MMR and certificate of analysis.
  • Electronic signaturesProfessional and Enterprise
    Name, date and time, and meaning.
  • Deviation managementProfessional and Enterprise
    Exceptions linked to steps.

People review the record and decide release. AI never edits records or signs.

Try it with one of your own batch records.

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