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QUAIL

AI review for GMP batch records

The review layer for everydocument behind a batch release.

QUAIL reads batch records, logbooks, deviations, and SOPs, handwriting included. It flags every issue with the page and clause cited. QA keeps the release decision.

See how it works

Built for 21 CFR Part 11 · ALCOA+ · EU GMP Annex 11

app.tryquail.com/reviews/BPR-1842

Reading · 1/86

Batch review

BPR-2026-1842 · Filling line 3 · Lot L-4419 · 86 pages

Package: record + LB-3 + SOP 4.2.1 + QC-07

  1. 01
  2. 02
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  4. 04
BPR-1842 · FillingPage 01 / 86

Operator

Time

Temp

Verified by

Reading handwriting and stamps

Checked against

  • SOP 4.2.1Line clearance
  • Spec QC-072–8 °C cold chain
  • MES lot L-4419Identity
  • Logbook LB-3Equipment use

Observations

  • DeviationOperator initials missing at step 12p.12 · SOP 4.2.1 §3
  • Needs reviewTemperature 8.4 °C outside 2–8 °Cp.18 · Spec QC-07
  • ConfirmedLot number matches MES recordp.3 · cleared

QA disposition

awaiting a person
AcceptRequest correctionRaise deviation

01The problem

Finished product waits on paper.

Batch release waits on a person reading every page with handwritten entries, verifying each record against SOPs and work instructions.

  1. 100+

    pages per batch

    Finished lots cannot ship

    Manual review takes weeks to months while product sits in the warehouse, tying up capital and incurring specialized storage costs.

  2. Review

    blocked on manual verification

    Current systems cannot read it

    Initials, corrections and missing fields are handwritten. Current systems read typed data, so QA reviews those records by hand.

  3. 1

    missed or incorrect entry

    Found late, it is a recall

    A gap caught in review is a conversation. Caught after the lot has moved, it is a batch scrap, an investigation or a recall.

02How it works

Every page read. Every issue cited. Every release decided by QA.

Batch records, logbooks, deviations, and SOPs reviewed as one package, not page by page.

  1. 01

    Upload the package

    Batch record, logbooks, SOPs

  2. 02

    Read every page

    Handwriting included

  3. 03

    Cross-check the set

    Against SOPs and limits

  4. 04

    Flag with the clause

    Page and SOP cited

  5. 05

    QA signs off

    Release stays human

How QUAIL reads a page, cross-checks it and cites the clause

03Platform

One workspace for the review, the deviation, and the sign-off.

Review is where an issue starts, not where it ends. QUAIL carries each finding through to a closed action and a signed record.

  • /review

    Batch record review

    Upload the package. Every page is read, every issue is flagged with the page and clause cited.

  • /deviations

    Deviations

    Open, investigate, and resolve deviations with evidence and comments attached to the record.

  • /actions

    Actions

    Corrections and follow-ups tracked to closure, each with an owner and a due date.

  • /sign-off

    Sign-off and audit trail

    Review policies by role. Every read, flag, and decision attributable and time-stamped.

  • /team

    Team and roles

    Reviewers, approvers, and auditors, scoped to your organization and invited by email.

  • /metrics

    Metrics

    Review time, open findings, and backlog across lots, on one dashboard for the plant.

Every module follows GxP practice — each action attributable, time-stamped and signed.

04Outcomes

Release in days, with the record to prove it.

Faster review, fewer escapes, and an audit trail an inspector can read. QA still signs.

  • Less QA time per record

    Review time reduced by up to 90%, with every issue already highlighted and reasoned.

  • Lots released within days

    Release stops waiting on an unread batch record.

  • Fewer costly recalls

    Catch the gap while the lot is still in house, not after it has moved.

  • Always inspection-ready

    Every action tracked in the audit trail, ready to share for inspection.

05Why now

The last unread pile in the plant.

Every plant has the same stack of paper between a finished lot and its release. Three things changed.

  1. 01

    Paper still runs release

    Floor records still carry handwritten entries. The digital stack reads typed data, so the pages that decide release stay a manual job.

  2. 02

    Inspections look at the trail

    FDA and EU guidance ask who recorded what, when, and who signed it. Data integrity is judged on the record, not only the result.

  3. 03

    Quail reads the handwriting

    Initials, corrections and stamps, read off the page and checked against the SOP behind them. Each one cites where it came from, so QA confirms the reading rather than trusting it.

06Who it's for

Quality teams with paper on the floor and a queue that will not wait.

A fit for plants running ten or more batches a month with paper floor records, a review backlog, or an inspection on the calendar.

  • Quality assurance

    See the issue, the page, and the SOP clause together. You still make the release call.

  • Operations

    Lots leave the warehouse in days instead of waiting on an unread batch record.

  • Quality systems

    Sits beside LIMS, MES, and eBR. A review layer, not a replacement for the stack you validated.

IndustriesPharma and CDMOReagentsCleaning and chemicalMedical devicesSupplementsAnimal health

07Trust

An assistant, not an autopilot.

Every step is attributable and time-stamped, and a person still signs the batch.

Attributable

Every read, flag, and decision is tied to a named user.

Time-stamped

The trail shows when each step happened, in order.

Human sign-off

QUAIL flags. A qualified person releases the batch.

21 CFR Part 11ALCOA+EU GMP Annex 11Security and trust

Book a demo

See QUAIL on your own documents.

Bring a batch record or a logbook from your line. We walk through it together.