WorkflowManufacturing & Quality

Batch Disposition Dossier & QP Release Desk

QP batch release with a cited dossier for every batch, and every blocker named

Every batch reaches the Qualified Person with a full, cited release dossier and every blocker named.

Watch the film Book a demo

See one case, screen by screen ↓

demo46sto assemble a biologic’s release dossier — 112 records read from 7 systems, 24 citations

demo18checksover EU GMP Annex 16 §1.7, each met, met with a note, or a blocker with an owner

target<1dayto assemble and review a release dossier; 2.6 days by hand

target71%of dossiers clear first time, with no blocker

The problem

Why batches wait in quarantine after the last result is in

Before a Qualified Person can certify a batch, every line of Annex 16 §1.7 has to be true for it — and the proof sits in seven systems. The batch record review is in MES, the results and certificate of analysis in LIMS, the deviations, changes and complaints in the quality system, the room and water data in EM, the material and supplier status in ERP, the market approvals in the regulatory system, the serial numbers in the EU hub.

So the QP or the release desk opens each one, copies what they find into a checklist, and chases whatever is still open: an impact assessment waiting for QA, a supplier audit that lapsed last month, a QP confirmation from the drug-substance site, a change approved in the EU but not yet in Canada. Each open item is found late, by hand — while the batch, and its value, sits in quarantine against a need date.

target2.6daysto assemble and review a release dossier by hand

target20.2daysmedian from made to certified, before the release desk

demo€63.6Mheld in quarantine at one plant on one morning — 8 batches

Where a release dossier’s days goestimated

By hand2.6 days

With the solution0.8 days

Collecting records from seven systems0.9 → 0.1 d
Checking results against the registered specification0.4 → 0.1 d
Tracing deviations, changes and market approvals0.6 → 0.2 d
Supply chain, audits and QP confirmations0.4 → 0.1 d
QP review and decision0.3 → 0.3 d

Estimated split of dossier assembly and review for one batch, by hand and with the solution. QC testing time is not included.

How it works

How a batch moves

A release coordinator and six specialist agents check the record, results, deviations, environment, supply and markets of every batch; the Qualified Person certifies.

What comes in

Batch readyBatch evidence · records, lab results, quality, supply

Agents at work

Release coordinator18-line checklist

Then

Batch record reader

Results and CoA checker

Deviation and change tracer

Environment and utilities checker

Supply chain and materials checker

Market and serialisation checker

Then

Certificate drafterdraft ready to sign

A person decides

Qualified Personcertify, hold or reject

What comes out

Signed certificate

Blockers to their owners

One case, step by step

One batch, from last QC result to certified

QC releases the last results for Veltrimab batch VL26-0418 at 07:52. It is needed at the EU distribution centre on Oct 9. Here is the QP’s morning, screen by screen, in the working solution.

01Morning
The release runway, before the first coffee
Lena Ortiz · Qualified Person
Lena opens the desk at Plant 3 — Leiden: 8 batches in quarantine worth €63.6 M, 2 ready for her signature, 4 blockers, and 1 new dossier to assemble. The runway shows each batch from made to needed-by, with today and the forecast release. CR26-1102 is already flagged: its forecast of Oct 11 misses the Oct 9 need date, and the supply planner has been told.
“CR26-1102 will miss its Oct 9 need date at the current forecast — Priya Raman informed.”
0207:52
Results are in — the dossier is ready to assemble
Lena Ortiz · Qualified Person
VL26-0418: 48,210 prefilled syringes of Veltrimab 150 mg/mL for DE, FR, NL, ES and IT, needed Oct 9, €11.6 M held. The screen lays out what the dossier will check — 18 lines across batch record and process, QC results, deviations and investigations, changes, environment and utilities, materials and supply chain, and market and distribution — with the batch record review report already open beside it.
“Each line comes back met, met with a note for you to read, or a blocker with the person who can clear it. Agents never certify — the decision and the e-signature stay with you.”
0346 seconds
Six specialists read seven systems
Release coordinator
Lena presses Assemble dossier. The coordinator sends each line to its specialist — MES, LIMS, the quality system, EM, ERP, the regulatory system and serialisation — and each step reports what it found: 214 steps signed with 3 exceptions dispositioned, 17 results against the registered specification, 1,284 EM samples with 1 Grade B excursion, closed. 112 records read, 24 citations, and the verdict: 15 met, 2 met with a note, 1 blocker, owner told.
“Verdict written — 1 blocker, 2 notes, 15 met · owners told.”
04The blocker
One deviation stands between the batch and certification
Deviation and change tracer
DEV-26-1187, major: the stopper bowl on filling line FL-2 jammed, so the formulated bulk was held 26 h 40 min against the 24 h batch-record limit. The hold-time study VR-114 supports 36 h at 2–8 °C and the impact assessment concludes negligible impact — but QA approval is still pending, with Omar Haddad, due 12:00. The deviation report opens beside it, with the exact passage highlighted.
The tracer never marks a deviation closed — it cites the approval record, not the summary.
05Notes to read
A market dropped, an excursion explained
Deviation and change tracer
VL26-0418 is the first batch with stoppers from the second-source supplier, lot WE-7731. Change control CC-26-0233 shows the EU type IB variation approved on Sep 2 and Canada filed Sep 18, approval pending — so the certificate covers the five EU markets only. A second note: settle plate B-07 in Grade B room F-214 read 6 CFU / 4 h against an action limit of 5 on the fill day; every Grade A sample read 0 CFU and the investigation closed Oct 3 with no impact.
“Destination markets DE · FR · NL · ES · IT are covered by the marketing authorisation and every change used. Canada is excluded until CC-26-0233 is approved there.”
0610:42
One chase, one approval, one line re-checked
Omar Haddad · QA operations
Lena presses Ask Omar to approve; the message goes to Omar Haddad with DEV-26-1187 and the cited records. Omar approves the impact assessment — negligible impact, batch added to the ongoing stability programme — and the coordinator re-checks only the line his record touches. The dossier turns: ready to certify, 15 met, 3 with a note to review.
07Certify
She reads the notes, and signs
Lena Ortiz · Qualified Person
The certify dialog states what she is certifying, lists the markets with Canada excluded, and will not let her sign until she ticks each note as reviewed — DEV-26-1187, CC-26-0233 and EM-26-0311. She chooses the meaning of the signature, Certified for release (Annex 16), and signs with her password.
“I certify that batch VL26-0418 of Veltrimab 150 mg/mL prefilled syringe has been manufactured and checked in compliance with the marketing authorisation and EU GMP (Directive 2001/83/EC Art. 51; Annex 16).”
0810:58
Certified, registered, released
Certification and release
Certified Oct 7 at 10:58 by Lena Ortiz — QPC-2026-1043, two days before the need date. The register entry is written, the signed certificate is issued with her e-signature manifest, ERP stock moves from Quarantine to Unrestricted for DE, FR, NL, ES and IT, the pick list is released and Priya Raman in supply planning is told.
09On file
The certificate, drafted from the checklist
Certificate drafter
The certificate of batch certification lists the product, the batch, the markets covered — “not Canada (CC-26-0233 pending)” — the checklist outcome and the notes the QP reviewed. The drafter left the signature block for the QP; once signed it carries her name, the meaning and the time, and the entry sits in the certification register.

Who it’s for

Built for everyone who stands between a batch and the market.

The same batch, seen by the five people who carry it to release — what their day looked like, and what it looks like now.

Lena OrtizQualified Person · Plant 3 — Leiden

Qualified Person

Before: Opens seven systems for every batch and finds the open item at the end of the review.
Now: Starts from a cited 18-line dossier with every blocker named, reads the notes, and signs.

Sam PatelQA release manager · US disposition

QA release manager

Before: Pieces together each batch’s status, open items and need date from several systems.
Now: Sees every batch in quarantine with its readiness, what is open and its need date — and approves US dispositions under 21 CFR 211.22 from the same dossier.

Omar HaddadQA operations · deviation and change approvals

QA operations

Before: Hears a batch is waiting on his approval when someone walks over to ask.
Now: Gets the chase with the deviation number and the cited records; when he approves, only that line is re-checked.

Priya RamanSupply planner, Europe

Supply planner

Before: Learns a batch will be late when the release date passes.
Now: Sees each batch’s forecast release against its need date, and is told the moment a forecast misses — or a batch is released.

Dr. Maya ChenHead of Quality · UK Qualified Person

Head of Quality

Before: Cannot see which part of release lead time is testing and which is paper.
Now: Sees release lead time by stage and product, what blocks release, and where to fix the system — and co-signs every rejection.

Built on the engine

8 agents. Each with one job, and hard limits.

A release coordinator and six specialist agents check the record, results, deviations, environment, supply and markets of every batch; the Qualified Person certifies.

Release coordinator

Opens the 18-line release checklist for each batch, sends each line to the right specialist, collects the evidence and writes the verdict: met, met with a note, or blocker with an owner. Re-checks only the affected lines when a source record changes.

Never certifies, holds or rejects a batch
Every line cites a source record
Market restrictions are always shown to the QP

Batch record reader

Reads the electronic batch record review: steps signed, exceptions and how each was dispositioned, in-process controls, inspection rejects and yield.

Reads only — never edits the batch record

Results and CoA checker

Compares every release result with the registered specification for the destination market, checks sterility and endotoxin, stability data age and the OOS / OOT register.

Uses the registered specification, never an internal alert limit, for pass or fail
An OOS or OOT result linked to the batch is a blocker until its investigation concludes

Deviation and change tracer

Finds every deviation, investigation, complaint and change that touches the batch, its materials or its equipment, and tests each against Annex 16 section 3 and the market approvals.

Never marks a deviation closed
Cites the approval record, not the summary

Environment and utilities checker

Pulls viable and non-viable monitoring for the batch’s rooms and sessions, water and clean utilities, and every excursion with its investigation.

An open action-level investigation is always a blocker

Supply chain and materials checker

Checks material status and supplier approval in ERP, audit currency for every party in the chain, technical agreements and QP confirmations from other sites.

Conditional supplier status is always shown

Market and serialisation checker

Checks each destination market against the marketing authorisation and the regulatory status of every change, the cold-chain lane and the serial-number upload.

Never adds a market the licence does not cover
Drops a market whose approval is missing, and says why

Certificate drafter

Drafts the disposition certificate and the register entry from the checklist, listing the notes the QP reviewed and the markets covered.

Draft only — the QP signs
Leaves the signature block for the QP

Qualified Person

Certifies, holds or rejects. The agents propose; a named person decides.

Ask in plain words

Ask about any batch, blocker or rule

Ask in plain words about any batch, blocker or rule — or describe a new release rule. Every answer cites the record behind it.

What is blocking VL26-0418?

One blocker and two notes. DEV-26-1187 is not closed: the bulk was held 26 h 40 min against the 24 h limit; the hold-time study supports 36 h and the impact assessment says negligible, but QA approval is pending — Omar Haddad, due 12:00. Note: Grade B settle plate at 6 CFU on the Sep 18 fill, closed with no impact. Note: the second-source stopper is approved in the EU but not yet in Canada — certify for the five EU markets only. If Omar approves today you can certify this afternoon.

Which batches can I certify today?

Three are ready with nothing open: VL26-0419 (EU, needed Oct 13), TX26-0090 (EU, needed Oct 10) and VL26-0421 (US, needed Oct 14). TX26-0090 carries one note — an open cap complaint on another batch. VL26-0421 is a US disposition for Sam Patel.

Which batch is at risk of missing its supply date?

CR26-1102 (Corventa 20 mg, DE · PL · CZ). It is needed on Oct 9, but the forecast release is Oct 11 because the dissolution OOS is in Phase II — Phase I found no lab error. Priya Raman has the alert; Poland has 9 days of stock cover, so she can bridge with CR26-1099 stock.

Let minor deviations close after certification when the impact assessment is approved

Done — new release rule: a minor deviation may stay open at certification when its impact assessment is approved and the registered specification is met (Annex 16, section 3). Major and critical deviations still block. Across the batches in quarantine it changes nothing today — the only open deviation, DEV-26-1187, is major. The rule is in Settings as version 7 and recorded in the audit trail.

Every screen

The working solution, as it ships.

13 screens from the working solution, on its sample data. Pick one to see it large.

Batch Disposition Dossier & QP Release Desk — Release runway — **Release runway**Batches in quarantine and their value, what is ready to sign, what blocks release, and each batch from made to needed-by with its forecast.

Batch Disposition Dossier & QP Release Desk — Every batch — **Every batch**Every batch in quarantine and every decision in the last 30 days — stage, readiness, what is open, need date and value.

Batch Disposition Dossier & QP Release Desk — Ready to assemble — **Ready to assemble**The 18 checks the dossier will run over Annex 16 §1.7, the seven systems it reads, and the batch record review report beside it.

Batch Disposition Dossier & QP Release Desk — How the dossier was built — **How the dossier was built**Each specialist’s step with what it found and how long it took — records read, citations and assembly time.

Batch Disposition Dossier & QP Release Desk — The release dossier — **The release dossier**The verdict, the blocker with its owner and due date, the notes to review — and the source record open with its passage highlighted.

Batch Disposition Dossier & QP Release Desk — Notes, with their record — **Notes, with their record**A note opens its source — here the change control showing the stopper approved in the EU and pending in Canada.

Batch Disposition Dossier & QP Release Desk — Ready to certify — **Ready to certify**Once the owner approves, the coordinator re-checks the one line it touches and the dossier turns ready.

Batch Disposition Dossier & QP Release Desk — QP e-signature — **QP e-signature**The statement, the markets covered, every note ticked as reviewed, the meaning of the signature and the password.

Batch Disposition Dossier & QP Release Desk — Certified and released — **Certified and released**Register entry, signed certificate, ERP stock to Unrestricted for the certified markets, and supply planning told.

Batch Disposition Dossier & QP Release Desk — The certificate — **The certificate**Drafted from the checklist — markets covered, checklist outcome, notes reviewed — signed by the QP and entered in the certification register.

Batch Disposition Dossier & QP Release Desk — Blockers board — **Blockers board**What stands between each batch and release, by the person who can clear it — chase with the cited record and the need date.

Batch Disposition Dossier & QP Release Desk — Release lead time — **Release lead time**Median days from made to certified, where the days go by product, what blocks release, and blockers by evidence family.

Batch Disposition Dossier & QP Release Desk — Release rules — **Release rules**What blocks and what shows as a note, the stability and supplier audit windows, and who signs for each market.

Governance

Built for certification: cited, signed, on the register.

Every line cites its recordEach of the 18 checklist lines points to the record it rests on — the batch record review, the CoA, the deviation report, the change control — with the passage highlighted.

Source systems are read, never changedMES, LIMS, the quality system, EM, ERP, the regulatory system and serialisation are read-only connections, checked every 15 minutes. No agent closes a deviation or edits a batch record.

Only the QP certifiesAgents never certify, hold or reject. The QP signs with a password and the meaning of the signature — Certified for release (Annex 16), or Approved for distribution (21 CFR 211.22) for the US quality unit.

No signature without the notes readEvery note on the dossier — a closed excursion, a market restriction, an approved impact assessment — must be ticked as reviewed before the signature is accepted, and the certificate lists them.

Markets the licence covers, and no othersA change not approved for a market restricts the certificate to the approved markets, and the restriction is always shown to the QP — as with Canada on VL26-0418.

A register inspectors can openEvery certification and disposition is an e-signed, immutable entry in the certification register, kept at least five years. A rejection needs a second signature from the Head of Quality, and every chase, approval and re-check is on the batch’s activity trail.

Configuration

Your release rules, not ours

What blocks certification, what shows as a note, and who signs for each market are settings — versioned, with the Annex 16 reference beside the rules it comes from.

Setting	Default	Choose from
Any open deviation blocks certification	On	Required by Annex 16 — cannot be switched off
An open action-level EM investigation blocks certification	On	On · Off — closed excursions show as a note
A change not approved for a market restricts the certificate to approved markets	On	On · Off
Supplier status “conditional” shows as a note	On	On · Off — lapsed audits of critical materials stay blockers
Re-check only the lines a changed record touches	On	On · Off
Ongoing stability data no older than	120 days	30 to 365 days, in steps of 30
Supplier audits valid for	36 months	12 to 60 months, in steps of 6
Who signs EU certification · UK certification · US disposition	Lena Ortiz · Dr. Maya Chen · Sam Patel	EU: Lena Ortiz or Dr. Maya Chen · UK: Dr. Maya Chen or Lena Ortiz · US: Sam Patel or Omar Haddad

Connections

Reads the systems your release already depends on

Batch records (MES)review-by-exception reports

Laboratory (LIMS)results, certificates of analysis, OOS register

Quality systemdeviations, changes, complaints, audits

Environmental monitoringviable, non-viable, utilities

ERPmaterial and stock status, suppliers

Regulatory and serialisationmarketing authorisations, variations, EU hub uploads

What it changes

The difference, in numbers.

Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.

target

<1day

to assemble and review a release dossier; 2.6 days by hand

By hand2.6 days

With agents< 1 day

target

71%

of dossiers clear first time, with no blocker

clear when first assembled

target

17.6days

median from made to certified, down from 20.2 days

Before20.2 days

With agents17.6 days

“demo” = seen in the working solution, on its sample batches · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Annex 16 references are EU GMP Annex 16, as cited in the working solution. People, companies and products named on this page are fictional — characters and sample data in the working solution.

Questions

What QPs and QA release teams ask us.

What is QP batch release software?

Software that brings together everything a Qualified Person needs to certify a batch — batch record review, QC results and CoA, deviations, changes, environmental monitoring, supply chain and market approvals — and records the certification. The QP Release Desk adds agents that assemble that evidence into a cited release dossier and name every blocker with its owner.

How does it build the release dossier?

When the batch record review is complete or the last QC result is released, the release coordinator opens an 18-line checklist over EU GMP Annex 16 §1.7.1–1.7.21 and sends each line to a specialist agent reading MES, LIMS, the quality system, EM, ERP, the regulatory system or serialisation. Each line comes back met, met with a note, or a blocker with an owner and a due date, and cites its record.

Does the AI certify or reject batches?

No. The agents never certify, hold or reject a batch. The Qualified Person — or the quality unit for a US disposition — decides and signs; the certificate drafter only prepares the draft and leaves the signature block for them.

How is the certification signed?

With an electronic signature: the signer’s password and the meaning of the signature, such as Certified for release (Annex 16), recorded with their name and the time. The signature is only accepted once every note on the dossier is ticked as reviewed, and the entry goes into the certification register.

What happens when a change is not approved in every market?

The certificate is restricted to the markets whose licence covers the change, and the restriction is always shown to the QP. In the working solution, a second-source stopper approved in the EU but pending in Canada limits batch VL26-0418 to DE, FR, NL, ES and IT.

Does it chase the people who can clear a blocker?

Yes. Each blocker carries its owner from the source record; a chase sends them the cited record and the need date. When the owner closes or updates the record, the coordinator re-checks only the lines it touches, and supply planning is told when a forecast release will miss its need date.

Can we set our own release rules and signers?

Yes. What blocks certification, what shows as a note, how old stability data may be, how long supplier audits stay valid, and who signs EU, UK and US decisions are settings. New rules can be described in plain words and are added as a new rules version; rules Annex 16 requires cannot be switched off.

How long does it take to go live?

The Agentic Solution Engine builds and deploys it from your requirements and documents — your release procedure, checklist, certificate template and a sample of recent batches — and it goes live once every quality gate has passed. We will walk you through it on your own batches first.

Manufacturing & Quality

More in this division.

All 11 solutions →

Batch Record Assistant

Any batch-record question answered in seconds, cited to the exact page and step.

1-min film Validation Documents

Validation protocols and reports drafted in minutes, every value traced to its source page.

1-min film Ask the Plant

Batch analysis that took three months now takes hours, with the query behind every answer.

1-min film

See it on
your batches.

We’ll run the QP Release Desk on a sample of your own recent batches.

Book a demo Browse solutions

Batch Disposition Dossier & QP Release Desk

Why batches wait in quarantine after the last result is in

How a batch moves

One batch, from last QC result to certified

The release runway, before the first coffee

Results are in — the dossier is ready to assemble

Six specialists read seven systems

One deviation stands between the batch and certification

A market dropped, an excursion explained

One chase, one approval, one line re-checked

She reads the notes, and signs

Certified, registered, released

The certificate, drafted from the checklist

Built for everyone who stands between a batch and the market.

8 agents. Each with one job, and hard limits.

Ask about any batch, blocker or rule

The working solution, as it ships.

Built for certification: cited, signed, on the register.

Your release rules, not ours

Reads the systems your release already depends on

The difference, in numbers.

What QPs and QA release teams ask us.

More in this division.

See it onyour batches.

See it on
your batches.