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.
Prepare batch B-2407 for reviewQualityWorking
Trace requirements to testsValidationWorking
Find the gaps in a tech transferDevelopmentNeeds your input
Draft line clearance from SOP-QA-017ManufacturingNeeds your input- Compare runs where yield fellDevelopmentReady to review
- Compare CAPA-301’s event ratesQualityReady to review
QualityWorking
Prepare batch B-2407 for review
Reading the batch recordChecking QC against the specTracing DEV-038 to its batches
Open the job →
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.
Developmentawake, 2 jobsQualityawake, 2 jobsManufacturingawake, 1 jobValidationawake, 1 job
Your ownnewDevelopment
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.
What must the receiving site resolve before the trial?
Three transfer gaps to resolve.
| Requirement | Sending site | Receiving site | 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 |
Sending process v04
- Hold temperature
- 2–8 °C
- Vessel capacity
- 100 L
- Working volume
- 80 L
- Mixing speed
- 300 rpm
- Sampling
- Outlet sample point
The supplied excerpt establishes the requirements to map. It does not contain a receiving-site comparability assessment.
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.
| Check | Record | Where it stands |
|---|---|---|
| Execution | B-2407 | Complete |
| SEC purity | QC-2407 | 98.6%, in spec |
| Other QC reports | BR-012 | 2 not attached |
| Deviation | DEV-038 | Assessment pending |
B-2407
- Execution
- Complete
- QC evidence
- QC-2407 attached
- Linked deviation
- DEV-038
- Review status
- Awaiting QA review
Completed execution is one part of the review package.
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.
| Test | Supplier CoA | Specification | 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 |
CoA RM-882
- Material / lot
- MAT-012 / RM-882
- Identity
- Pass
- Assay
- 99.4%
- Water
- 0.3%
- Residual solvent
- Not reported
The supplied certificate does not report a residual-solvent result. No separate report is included.
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.
| Question | Drafted answer | Where it stands |
|---|---|---|
| Are changes assessed for customer impact? | Yes. Customer commitments and notification requirements are assessed before approval. | SOP-CC-012 v05 |
| How do you record training? | By employee and procedure version, with completion date and assessment outcome. | SOP-TR-003 v02 |
| Last customer audit date | Add the date from the audit record. | Needs your input |
SOP-CC-012 v05
- Title
- Change control
- Section
- 4.2 Impact assessment
- Status
- Approved
Before approval, assess changes for product quality, validated state, regulatory filings and customer commitments. Record customer notification requirements in the assessment.
NextQA adds the audit date and approves the answers.
From SOP-CC-012 v05 and SOP-TR-003 v02
Download CSV ↓Can we show the operators were trained on SOP-021 v03?
One training record still to find.
| Evidence | Record | What it shows | Where it stands |
|---|---|---|---|
| Procedure released | CHG-062 | Signed, effective 1 August | Found |
| Operator A trained | TRN-114 | Completed 3 August | Before the work |
| Operator B trained | Search | No completion located through 5 August | Missing |
SOP-021 v03
- Revision
- v03
- Effective
- 1 August
- Approval link
- CHG-062
- Training requirement
- Before independent work
The request is specific to this revision and the two named operators’ work on 5 August.
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.
| Run | At 18:00 | Next | Where it stands |
|---|---|---|---|
| RUN-402 | Hold active | Check at 18:30 | To assign |
| RUN-403 | Issue unresolved | Owner update | Open |
| RUN-401 | Execution complete | QA review | Not released |
RUN-401
- Execution
- Complete
- QA review
- Pending
- Next recorded work
- QA review
- Release
- Not released
Execution completion does not mean the batch is 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.
MSAT
Why is post-thaw viability falling?
Neil
Longer holds coincide with lower viability. All eight runs stayed within the approved limit.
Viability by time from thaw to count8 runs95%91%20 min45 min, the limitFrom the batch records, their timestamps and QA-PROC-014 v04. The records don’t establish a cause.
Neil
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
QA
Awaiting signature
Sign and release v05RUN-218
Follows v04 until you release v05.
It checks the work as it’s done.
Every result is read against its limits, its controls and the runs before it as soon as it’s saved. A problem reaches the person who can fix it before anyone signs.
- 16:40Host cell protein, DS-031Below its limit
- 16:02Bioburden, pre-filtrationChecked
- 15:11Potency, 6 months 25 °CControl failed
- 14:30SEC purity, 9 months 5 °CThird run
- 12:20pH and osmolality, B-12Checked
- 10:58Precision qualificationChanged after signing
- 10:19ELISA on standard RS-77Expired standard
- 09:47Titre by Protein A HPLCAnother run’s data
31 earlier recordsNothing to raise
ELN-2291Saved 16:40Flagged 16:41
Spike recovery below its limit, marked Pass
1Reads the result
ELN-2291, results
- Spike recovery
- 46%
- Result
- Pass
2Opens the method the record cites
HCP-ELISA v4, section 7.2
Spike recovery must be within 50 to 150% for a result to be reported.
3Opens the plate data
hcp-0412.xlsx, spiked wells, ng/mL
Well Added Found Recovery C3 20.0 9.2 46% C4 20.0 8.8 44% C5 20.0 9.6 48% 4Flags it at 16:41
Spike recovery is 46%, below the method’s 50% limit, but the record says Pass. With recovery this low, the lot’s result could be about half the true value.
To the analyst, before signing.
ELN-2307Saved 15:11Flagged 15:12
Reported from a plate whose control failed
1Reads the result
ELN-2307, results
- Sample potency
- 98%
- Reported to
- Stability summary SS-01
2Opens the method’s control limit
POT-CB v2, section 6.1
The reference standard’s EC50 must fall within 1.5 to 3.0 ng/mL, or the plate is invalid.
3Opens the plate reader’s export
pot-0917.csv, curve fits
Curve EC50, ng/mL R² Reference 3.9 0.991 Sample 3.3 0.994 4Flags it at 15:12
The reference standard failed its limit, so this plate can’t give a valid potency. Its 98% is already in the stability summary.
To the analyst and the stability lead, before the summary is signed.
ELN-2351Saved 14:30Flagged 14:30
A third run of a sample that failed twice
1Sees a run of a sample tested before
ELN-2351, started 14:30
- Sample
- STB-09-05
- Test
- Purity by SEC, 9 months
2Finds the earlier runs
Records for STB-09-05
Record Purity Comment ELN-2340 93.1% Invalid, retest ELN-2344 93.4% Invalid, retest 3Opens the stability protocol
STP-12, table 2
Purity by SEC: at least 95.0% at every time point.
4Looks for an investigation
Deviations, STB-09-05
- Open
- None
5Flags it at 14:30
Two results below the 95% limit were set aside with no cause recorded, and no investigation is open. This point needs one, not a third run.
To the analyst and quality, as the run started.
ELN-2368Saved 10:58Flagged 10:59
A signed Fail, unlocked and now a Pass
1Reads the record’s history
ELN-2368, audit trail
When What Yesterday 11:20 Version 3 signed: Fail Today 10:58 Replicate 4 removed, no reason Today 10:58 Version 5: Pass, not signed 2Recalculates with every replicate
ELN-2368, replicates, % of label
1 2 3 4 5 6 RSD 101.6 96.8 98.6 118.9 98.7 102.7 7.9% 101.6 96.8 98.6 98.7 102.7 2.4% 3Opens the qualification protocol
QP-031, section 5.3
Intermediate precision: RSD no more than 5.0%. A result is excluded only with a documented cause.
4Flags it at 10:59
A signed Fail became a Pass when replicate 4 was removed with no reason given. With every replicate counted, precision is 7.9% against a 5.0% limit.
To quality and the first reviewer, before it’s signed again.
ELN-2433Saved 10:19Flagged 10:20
One expired standard behind three studies
1Reads the reagents used
ELN-2433, reagents
- Reference standard
- RS-77
- Kit lot
- K-5512
2Finds every run on RS-77
Records using RS-77
Record Run Control ELN-2410 14 Oct 0.82 ELN-2415 21 Oct 0.79 ELN-2433 Today 0.71 3Opens the certificate and the log
RS-77 certificate, storage
Use within 60 days of opening. The reagent log has it opened on 12 August.
4Flags it at 10:20
Three studies used RS-77 after its use-by date of 11 October, and its control has fallen in every run. The two that passed may be affected too.
To all three teams.
ELN-2452Saved 09:47Flagged 09:48
Raw data from a different study
1Reads the record
ELN-2452, run
- Run
- Today
- Samples
- P-2452-01 to 06
2Opens the attached file
titre-0814.cdf, instrument header
- Acquired
- 14 Aug, 09:12
- Samples
- P-2219-01 to 06
3Finds where the file belongs
ELN-2219, raw data
- File
- titre-0814.cdf
- Peak areas
- The same as today’s
4Flags it at 09:48
The raw data attached here comes from a study run on 14 August. Today’s results have no raw data behind them.
To the analyst, as the file was attached.
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.
Neil works in your Word, Excel and PowerPoint files.
Open Neil in the document you’re working on, with nothing to upload or paste. It changes the file only once you accept edits. You check the change and save.
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.
- STAB-016Assay %10595100.298.997.4Initial3 mo6 mo9 moLabReview a stability trend
- INJ-103Impurity peakOriginal0.18%Reprocessed0.12%ReasonBaselineReviewMissingLabCompare chromatography integration changes
- Batch 205kgChargedCHARGE-205100.0ProductOUTPUT-205−96.0SamplesSAMPLE-205−1.0ResidualLOSS-205−2.0Unexplained1.0ManufacturingTrace a material-balance discrepancy
- LOG-204Container C28 °C10:1010:4232 minManufacturingTrace a cold-chain excursion
- DEV-04214 min logged09:12Temperature alarm09:18Operator acknowledged09:26Back in rangeProduct assessmentNot recordedQualityDraft a deviation investigation
- AT-309Sample identity10:00S-91Recorded10:06S-19CorrectedReasonTranspositionLabel imageNot attachedQualityPrepare a GxP audit-trail review