AiVACO · Inspection evidence pack

ASM-0011 — Aseptic gowning requalification current for all staff

Generated 2026-10-26 15:23:17 UTC · assembled from the live audit trail, not a template

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

1. Record

Source system	LMS · TRN-0322
Process stage	Manufacturing
Summary	Annual gowning requalification completed for all 22 aseptic operators.
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	94%, recommendation: clear (engine: simulated)
AI reasoning	Every operator is requalified within the last 12 months. Nothing outstanding.
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 94%.
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 2 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 94%.

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 2 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-HR-004 GMP Training	21 CFR 211.25 · EU GMP Ch.2
SOP-MFG-031 Aseptic Filling	EU GMP Annex 1 · ICH Q9(R1)

Company control

Regulation / guideline

SOP-HR-004 GMP Training

21 CFR 211.25 · EU GMP Ch.2

SOP-MFG-031 Aseptic Filling

EU GMP Annex 1 · ICH Q9(R1)

4. Controlled documents relied on

SOP-MFG-031 v4.0 §3.3 · Aseptic Filling — Gowning qualification
Operators in aseptic areas hold a current gowning qualification, renewed every 12 months. An operator without a current qualification does not enter the aseptic area.

SOP-HR-004 v6.0 §3.4 · GMP Training — Annual refresh
GMP training is refreshed annually. Overdue training removes the person from unsupervised GMP tasks until it is completed.

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
48	2026-10-26 11:10:36 UTC	connector.lms	Record TRN-0322 pulled from LMS	a0199654289d…
49	2026-10-26 11:10:36 UTC	ai.simulated	AI proposed a grade of A1 (RPN 6, 94% confident) — Level 1	685e0d3faa74…
50	2026-10-26 11:10:36 UTC	assurance	Assurance Layer (rules v1.0.0) checked the AI proposal: passed all 8 checks	b019dd596325…
51	2026-10-26 11:10:36 UTC	system	Cleared automatically at Level 1 — no human needed	adfebf7e4773…

Time (UTC)

Who

Event

Hash

2026-10-26 11:10:36 UTC

connector.lms

Record TRN-0322 pulled from LMS

a0199654289d…

2026-10-26 11:10:36 UTC

ai.simulated

AI proposed a grade of A1 (RPN 6, 94% confident) — Level 1

685e0d3faa74…

2026-10-26 11:10:36 UTC

assurance

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

b019dd596325…

2026-10-26 11:10:36 UTC

system

Cleared automatically at Level 1 — no human needed

adfebf7e4773…