Development runs. Tech transfers. Batch reviews. Neil does the legwork. Your team decides.

It reads your runs and records, then drafts the comparison, the gap assessment or the review, so you start from a draft, not a blank page.

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Neil › Jobs

4 Neils awake

QualityWorking

Prepare batch B-2407 for review

Reading the batch recordChecking QC against the specTracing DEV-038 to its batches

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50+ companies, from GxP labs to GMP manufacturing.

Every Neil has its own computer.

A Neil for each kind of work, with its own instructions, access and computer. Each works on many jobs at once.

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Neil › Personas › Development

awake · 2 jobs

Development

Compare development and manufacturing runs, and list what a transfer still needs before the first run.

Access: Development, Manufacturing. Proposes changes.Never more than the person asking it.
Computer: Its own. Keeps the script behind each comparison, so you can rerun it.
Jobs: Compare runs where yield fellReady to review
Find the gaps in a tech transferNeeds your input
Skills: Run comparisonTransfer gap assessmentScale-upApproved by your team, shared by every Neil.
Signs: Nothing. People sign.

Quality

Check each batch record against its master record and the open deviations, ready for QA to review.

Access: Quality, Manufacturing. Proposes changes.Never more than the person asking it.
Computer: Its own. Keeps the checks it runs on every batch record.
Jobs: Prepare batch B-2407 for reviewWorking
Compare CAPA-301’s event ratesReady to review
Skills: Batch review briefCoA checkCAPA recurrenceApproved by your team, shared by every Neil.
Signs: Nothing. People sign.

Manufacturing

Configure approved procedures as processes in Seal, step by step, with their limits and checks.

Access: Manufacturing, Processes. Proposes changes.Never more than the person asking it.
Computer: Its own. Keeps its notes on each procedure, step by step, for review.
Jobs: Draft line clearance from SOP-QA-017Needs your input
Skills: Procedure to processStep limitsApproved by your team, shared by every Neil.
Signs: Nothing. People sign.

Validation

Trace each requirement to the test that covers it, and list what nothing covers yet.

Access: Validation, Equipment. Proposes changes.Never more than the person asking it.
Computer: Its own. Keeps the script behind each trace, so you can rerun it.
Jobs: Trace requirements to testsWorking
Skills: Traceability matrixTest scriptsApproved by your team, shared by every Neil.
Signs: Nothing. People sign.

Your own

The work you hand it, and how your team likes it done.

Access: What you grant it, as you would a colleague.Never more than the person asking it.
Computer: Its own, ready for its first job.
Jobs: What you hand it, many at once.
Skills: The methods your team approves.
Signs: Nothing. People sign.

It shows its work.

Every finding links to the record, version and field behind it. What the records don’t show, Neil says.

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Tech transfer › Receiving site

drafted by Neil

What must the receiving site resolve before the trial?

Three transfer gaps to resolve.

Sending process against receiving setup
Requirement			Where it stands
Hold	2–8 °C	2–8 °C in procedure	Mapped
Volume	80 L of 100 L	600 L of 1,000 L	Assess comparability
Mixing	300 rpm	300 rpm proposed	Rationale not linked
Sampling	Outlet sample point	Side port proposed	Confirm suitability

NextThe transfer team assesses comparability and approves the trial.

From Sending process v04, Receiving setup and T-014 plan

Full walkthrough

What’s missing from this batch review?

Two items still need attention.

What batch B-2407's review needs, and where each item stands
Check	Record	Where it stands
Execution		Complete
SEC purity		98.6%, in spec
Other QC reports		2 not attached
Deviation		Assessment pending

NextQA reviews the draft and decides.

From B-2407, QC-2407, DEV-038 and BR-012

Full walkthrough

Does this CoA cover the required tests?

Three results reported. One test missing.

Lot RM-882: the supplier's certificate against the specification
Test			Where it stands
Identity	Pass	Required	In spec
Assay	99.4%	98–102%	In spec
Water	0.3%	≤ 0.5%	In spec
Residual solvent	Not reported	Test required	Missing

NextThe reviewer resolves the missing test, then QA decides.

From CoA RM-882, MAT-012 v03 and Receipt RM-882

Full walkthrough

Can you fill in this customer questionnaire?

Two answers drafted from your SOPs. One needs you.

Draft customer questionnaire
Question	Drafted answer	Where it stands
Are changes assessed for customer impact?	Yes. Customer commitments and notification requirements are assessed before approval.
How do you record training?	By employee and procedure version, with completion date and assessment outcome.
Last customer audit date	Add the date from the audit record.	Needs your input

NextQA adds the audit date and approves the answers.

From SOP-CC-012 v05 and SOP-TR-003 v02

Can we show the operators were trained on SOP-021 v03?

One training record still to find.

SOP-021 v03: the evidence the audit question asks for, and what was found
Evidence	What it shows	Where it stands
Procedure released	Signed, effective 1 August	Found
Operator A trained	Completed 3 August	Before the work
Operator B trained	No completion located through 5 August	Missing

NextQA finds the missing training record, then approves the response.

From SOP-021 v03, CHG-062, TRN-114 and Operator B search

Full walkthrough

What does the incoming shift need to pick up at 18:00?

The next check is at 18:30.

The runs at the 18:00 handover, and what the incoming shift picks up
Run	Next	Where it stands
RUN-402	Check at 18:30	To assign
RUN-403	Owner update	Open
RUN-401	QA review	Not released

NextThe outgoing team checks the brief and hands over.

From RUN-401, RUN-402 and RUN-403

Full walkthrough

It proposes. Your team releases.

The way engineers ship code: Neil proposes the change, its tests run, QA signs, and the next run follows the rule.

See how continuous validation works

Neil › Jobs › Post-thaw viability

waiting for QA

MSAT3 Nov, 09:12
Why is post-thaw viability falling?
Neil09:31
Longer holds coincide with lower viability. All eight runs stayed within the approved limit.
Viability by time from thaw to count8 runs
95%91%
20 min45 min, the limit
From the batch records, their timestamps and QA-PROC-014 v04. The records don’t establish a cause.
Neil09:44
Proposed changeset #14 to QA-PROC-014, for QA to review.
Step 03: Post-thaw hold
- Hold timeLimit 45 30 min, thaw to count
- Over the limitOpens a deviation for QA
12 of 12 tests passed on v05
QANow
Awaiting signature
RUN-218Next
Follows v04 until you release v05.

Ready for the inspector’s questions.

The questions inspectors ask about AI in GMP work, answered by how Neil works.

Who made this decision?: A person. Neil drafts and proposes. It signs, approves and releases nothing.
What is this based on?: The records. Each finding links to the record, version and field behind it.
What didn’t it find?: It says so. Neil names what the records don’t show. It doesn’t fill the gap.
Could the AI change the process?: Only by proposing. The change’s tests run, then your team releases it.
What could it see?: What you grant it. Never more than the person asking.
Does our data train the model?: No. Under Seal’s agreements, it isn’t used to train the underlying models.

How Neil fits Annex 22

Give Neil a real job.

Start with the work that takes your team longest. Each job shows what Neil reads and the draft it returns.

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