AiVACO · Inspection evidence pack

ASM-0003 — Batch 24-0871 assay results within specification

Generated 2026-10-26 15:23:07 UTC · assembled from the live audit trail, not a template

Audit trail integrity: Intact. 68 records verified at generation time.

1. Record

Source system	LIMS · BATCH-24-0871-ASSAY
Process stage	Manufacturing
Summary	HPLC assay 99.2% of label claim (spec 95.0–105.0%). System suitability passed.
Current disposition	Cleared automatically by the AI under the routing rules

2. AI proposal and the rules applied

The AI proposes the factors below. The grade and the routing are computed by fixed rules (ICH Q9(R1)), never by the AI.

Severity	3 of 4
Occurrence	1 of 4
Detection	2 of 4
Uncertainty	0 of 2
Importance	1 of 2
Complexity	0 of 2
RPN (S × O × D)	6
Computed grade	A1 — risk level 1, formality A (commensurate with risk)
AI confidence	95%, recommendation: clear (engine: simulated)
AI reasoning	Result is well inside specification and system suitability criteria were met.
Routing	Level 1 — cleared without a human

Assurance Layer check on the AI proposal

Fixed rule set version 1.0.0, checked on 2026-10-26. Overall: passed.

Rule	Result	Detail
P1 · Scores are on the defined scales	Passed	All six scores are whole numbers inside their scales.
P2 · Confidence is a real percentage	Passed	Confidence is 95%.
P3 · Recommendation is one the platform allows	Passed	The recommendation is “clear”.
P4 · A reason is given	Passed	A reason is given.
P5 · It rests on documents that are in force today	Passed	All 1 named control(s) have a version in force.
P6 · Supporting text was found	Passed	2 supporting passage(s) found.
P7 · Formality matches the risk	Passed	Grade A1 is formal enough for the risk.
P8 · The AI did not try to lower the bar	Passed	The AI’s recommendation does not try to go below what the fixed rules require.

Rule

Result

Detail

P1 · Scores are on the defined scales

Passed

All six scores are whole numbers inside their scales.

P2 · Confidence is a real percentage

Passed

Confidence is 95%.

P3 · Recommendation is one the platform allows

Passed

The recommendation is “clear”.

P4 · A reason is given

Passed

A reason is given.

P5 · It rests on documents that are in force today

Passed

All 1 named control(s) have a version in force.

P6 · Supporting text was found

Passed

2 supporting passage(s) found.

P7 · Formality matches the risk

Passed

Grade A1 is formal enough for the risk.

P8 · The AI did not try to lower the bar

Passed

The AI’s recommendation does not try to go below what the fixed rules require.

3. Controls and the regulations they satisfy

Company control	Regulation / guideline
SOP-QC-003 Laboratory Testing	21 CFR 211.194 · EU GMP Ch.6

Company control

Regulation / guideline

SOP-QC-003 Laboratory Testing

21 CFR 211.194 · EU GMP Ch.6

4. Controlled documents relied on

SOP-QC-003 v5.0 §4.1 · Laboratory Testing — Specification review
Every result is compared with its approved specification and system suitability criteria. A result within specification with passing system suitability is reported without further review.

SOP-QC-003 v5.0 §4.5 · Laboratory Testing — Out-of-specification results
An out-of-specification result starts a laboratory investigation immediately and the batch is held until the investigation concludes.

5. Signature

No signature on this assessment.

6. Audit trail for this record

Each record is hash-chained to the one before it and cannot be edited or deleted. Record numbers refer to the platform-wide trail.

#	Time (UTC)	Who	Event	Hash
15	2026-10-26 11:10:33 UTC	connector.lims	Record BATCH-24-0871-ASSAY pulled from LIMS	14eb069a7596…
16	2026-10-26 11:10:33 UTC	ai.simulated	AI proposed a grade of A1 (RPN 6, 95% confident) — Level 1	bdcb284037a7…
17	2026-10-26 11:10:33 UTC	assurance	Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks	7a3b9705ef28…
18	2026-10-26 11:10:33 UTC	system	Cleared automatically at Level 1 — no human needed	01017bedf851…

Time (UTC)

Who

Event

Hash

2026-10-26 11:10:33 UTC

connector.lims

Record BATCH-24-0871-ASSAY pulled from LIMS

14eb069a7596…

2026-10-26 11:10:33 UTC

ai.simulated

AI proposed a grade of A1 (RPN 6, 95% confident) — Level 1

bdcb284037a7…

2026-10-26 11:10:33 UTC

assurance

Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks

7a3b9705ef28…

2026-10-26 11:10:33 UTC

system

Cleared automatically at Level 1 — no human needed

01017bedf851…