STB-AVI401-002XLSX
Source excerpt · Study!A1:B8
Havenor Therapeutics · Its newest medicine, Avericin, is finished and waiting for a health authority to approve it.
Task 08 · QC Stability Scientist
Review the 24-month stability-testing workbook
Review the colleague’s testing-plan workbook as the lab’s quality reviewer and leave it ready for others to act on.
DeepSeek V4.1 Flash caught 9 of 15 traps. See which →
3What just happened?
The 24-month shelf-life samples are due 1 March 2027, and the plan for testing them needs sign-off.
A colleague built a workbook planning which samples to pull, which machines and methods to use, and when results go to Quality and the regulator. Nothing starts until the lab’s quality team approves it.
4Who has to do what?
Review the colleague’s testing-plan workbook as the lab’s quality reviewer and leave it ready for others to act on.
- The seat
- Tomas Li, QC Stability Scientist
- What a good answer looks like
- It records who decided what, keeps the original entries, catches every expired or lapsing item, and turns each problem into an owned, dated action.
- What must be handed in
STB-AVI401-002_24M_pull_and_update_control.xlsx
The assignment as the model received it
Edit the controlled working workbook in place with attributable QC disposition, release gates, comments, and evidence controls.
5Which files decide it?
The planning workbook, equipment and calibration records, reference-sample records, the regulator’s questions, and the lab-error record.
The model also has the rest of the company’s shared drive, its chat and its record systems. Finding the right files is part of the job. Flip through the key ones below.
Company documents
Some of the documents available to the model.
Laboratory stability · workbook
The next results do not exist yet
The company date is 8 February 2027. The pull schedule distinguishes completed laboratory work from the next planned measurements.
An agent can prepare the update now, but cannot present the scheduled 24-month results as already reported.
6What did the model do?
What DeepSeek V4.1 Flash did, step by step.
In short: DeepSeek backs up the workbook, records send-backs and cell comments in its QC fields, and verifies that none of the original entries changed.
Step 41. Backs up the baseline workbook. Before editing, DeepSeek copies Tomas’s workbook so it can prove afterwards that his original entries are unchanged.
Command run by the modelcp "/app/_Working/Tomas Li/STB-AVI401-002_24M_pull_and_update_control.xlsx" /tmp/original_backup.xlsx
Step 42. Sends back the overwrap answer. The review asks for the registered film’s oxygen figure but quotes the proposing supplier’s comparison. It does not give a precise controlled-document and page citation for either the film figure or the headspace-oxygen control.
Text written into the workbookcite BF-51 OTR and headspace evidence; do not reference unapproved HF-55 (CC-AVI401-017).
Step 44. Verifies the baseline survived. DeepSeek compares the edited workbook with its backup and confirms that none of Tomas’s entries changed.
Verification resultBASELINE MISMATCHES: 0
Replay every step of the run →
Inside the run
A
Model
Backs up the baseline workbook
Model draft
cp "/app/_Working/Tomas Li/STB-AVI401-002_24M_pull_and_update_control.xlsx" /tmp/original_backup.xlsx
A
Before editing, DeepSeek copies Tomas’s workbook so it can prove afterwards that his original entries are unchanged.
1 / 3
7Which traps did it catch?
It caught 9 of 15.
Specialists wrote these checks from the real records before any model ran. Each is a weak spot a reviewer or inspector would find. A check passes only if the handed-in file states it.
Missed
Every fix needs an owner and a deadline R03
Each problem sent back must name one responsible person, a due date, what it blocks, what evidence closes it, and exactly where that evidence lives.
If missed, problems get flagged but never closed.
A separate go/no-go for each step R05
Pulling samples, each test, locking the data, and handing off to the regulator each need their own consistent conditions.
If missed, one step starts before what it depends on is ready.
List the complete testing chain R09
Every test in the specification needs its storage chamber, method, instrument and reference sample listed, and nothing unrelated.
If missed, a test can start with an unqualified piece of the chain.
Answer all seven regulator questions R11
The regulator asked seven numbered questions, including a small one about the filing’s page layout. Each needs an owner, the evidence required, and a route back to the regulator.
If missed, an unanswered question delays approval.
Did the lab error hit other tests? R14
A past test run was thrown out because of a mixing mistake. The record needs the cause, the replacement result, and a check of whether the same mistake affected other runs.
If missed, other results made with the same mistake stay on file.
Cite the current wrapper’s oxygen evidence R15
The answer needs the approved wrapper’s oxygen barrier at storage conditions and the oxygen inside the bags, with exact citations, not the proposed new film.
If missed, the regulator gets evidence about the wrong wrapper.
Caught
Sign and date the review honestly R01
The review is recorded under the reviewer’s name as of today (8 Feb 2027), without back- or forward-dating and without claiming to have changed official systems.
If missed, nobody can tell who decided what, and when.
Don’t erase the original entries R02
Corrections go into review columns and comments, so the colleague’s original entries can still be seen.
If missed, the trail of what was first proposed is lost.
Fix the batch-to-bag-size mix-up R04
Two test batches are 100 mL bags and one is a 250 mL bag. The workbook wrongly lists a 250 mL and a 500 mL batch; there is no 500 mL batch.
If missed, the wrong bags get tested and the worst case is never checked.
The storage chamber’s approval runs out R06
The chamber holding the samples is calibrated until December, but its separate qualification ends 28 February 2027 — the day before the samples are due.
If missed, the samples sit in an unqualified chamber and their results can be challenged.
A reference sample expires mid-campaign R07
The reference sample expires 19 March 2027. It can support the strength tests planned for 15–18 March, not the impurity tests planned for 22–26 March.
If missed, the impurity results are measured against an expired reference.
An instrument’s calibration ends before use R08
The leak-test instrument was calibrated 12 April 2026 for 12 months, so it is out of calibration for its planned use on 13–14 April 2027.
If missed, the leak-test results are invalid.
One timeline that adds up R10
The pull stays 1 March. All tests finish before the data lock, so a complete dataset can’t be ready for the 20 March response.
If missed, the company promises the regulator data it can’t deliver.
Demand a checked shelf-life calculation R12
The shelf-life answer needs an independently checked, per-batch calculation with projections and confidence limits.
If missed, an unchecked calculation goes to the regulator.
“Within the limit” doesn’t settle it R13
An accelerated-test result of 0.46% is under the 0.50% limit, but conflicting records mean someone must still formally decide whether it counts as a “significant change”.
If missed, a formal regulatory question is waved away.
Every model on the same job
One attempt each, same assignment and checklist, so treat small gaps as noise.
Workbook changes
STB-AVI401-002_24M_pull_and_update_control.xlsx
Selected cells before and after the model’s edits. Longer entries are shortened here.
280cells changed across the submitted workbook
Control5 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| C7 | Blank | 0.4 reviewed; not approved. Return as 0.5 after QC-01 to QC-14 close. |
| C11 | Blank | Pull authorization, dataset release and regulatory handoff withheld. See Review Actions QC-01 to QC-15 and the QC Disposition sheet. |
Pull Plan18 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| G2 | Blank | Hold - lot mapping correct, authorization withheld. |
| H2 | Blank | AVI401-R01 is correctly listed as 100 mL. The pull is not authorized because the testing-chain clearance is not complete (QC-12) and the chamber qualified state is not established (QC-02). |
Execution Sequence54 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| G2 | Blank | Not approved - wrong qualified-state basis. |
| H3 | Blank | MTH-VIS-002 (AVT-VAL-358, 2025-06-12) and MTH-PHY-004 (AVT-VAL-348, 2025-02-10) are current. The pH chain assets PH-03 (cal. 2026-09-20) and RS-BUF-021 (expiry 2027-10-11) are missing from Chain and Controls, so the chain is not cleared. |
Chain and Controls36 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| G2 | Blank | Not approved - wrong governing activity. |
| H2 | Blank | The chamber's qualified state is established by requalification under AVT-SOP-045 at a 36-month interval (AVT-STB-102-A4). The last requalification on file is CC-2023-004 (2023); it lapses before the 2027-03 pull. MER-2026-4587 (annual calibration, due 2027-12-05) is not the governing evidence. |
Regulatory Handoff36 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| G2 | Blank | Not approved - scope and timing wrong. |
| H2 | Blank | HA-AVI401-IR-2027-014 point 7 states the 24-month pull is not part of sequence 0003 and is to be provided under COM-AVI401-008; no earlier pull is requested for the letter. The written response due 2027-03-20 must answer points 1-6 from existing records. It cannot and need not supply the 24-month dataset. |
Review Actions120 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| B2 | Blank | Pull Plan!B2:B4, F2:F4; Long_Term_Results!Lots |
| C2 | Blank | Lot/presentation mapping is wrong. Source records (Long_Term_Results Lots; 3.2.P.8; AVT-STB-301) show AVI401-R01 = 100 mL, AVI401-R02 = 100 mL, AVI401-R03 = 250 mL. The workbook shows R02 = 250 mL and R03 = 500 mL; no 500 mL presentation exists. The 250 mL worst-case lot is R03, not R02. |
QC Disposition11 changed cells
| Cell | Baseline | Submitted entry / excerpt |
|---|---|---|
| B3 | Blank | 2027-02-08 |
| B2 | Blank | Not approved - returned for correction (hold). Pull, dataset release and regulatory handoff withheld while QC-01 to QC-15 are open. |
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