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Assurance Layer
Nothing the AI produces is used until fixed rules have checked it.
The AI is allowed to be wrong. This layer is what makes that safe. It is a short, written list of rules that never changes without a new version number, and every check it makes is saved in the audit trail with the version that ran.
- 1
The AI proposes
It reads a record or a question and drafts a grade, a recommendation or an answer. It never decides.
- 2
Fixed rules check it
Every proposal and every answer is run through the same written rules, in the same order, every time.
- 3
A failure stops it
A proposal that fails goes to a person. An answer that fails is withheld. Nothing unverified is used or shown.
- 4
The result is recorded
The report, with the rule-set version, is saved in the tamper-evident audit trail.
AI proposals checked
14
checked
14
passed
0
with warnings
0
blocked
Assistant answers checked
2
checked
2
passed
0
with warnings
0
blocked
Rule set v1.0.0Fingerprint
e5ca4084fe80The fingerprint changes if any rule changes, so a saved check can always be tied to the exact rules that ran.Rules for AI proposals
Applied the moment a record arrives, before the AI’s proposal is used.
| Rule | What it checks | If it fails | Proposed regulation links |
|---|---|---|---|
| P1 · Scores are on the defined scales Blocking | Severity, occurrence and detection are whole numbers from 1 to 4. Uncertainty, importance and complexity are whole numbers from 0 to 2. | The proposal is blocked. It cannot be cleared automatically and goes to a person. |
|
| P2 · Confidence is a real percentage Blocking | The AI’s stated confidence is a number between 0% and 100%. | The proposal is blocked. It cannot be cleared automatically and goes to a person. |
|
| P3 · Recommendation is one the platform allows Blocking | The AI’s recommendation is one of: clear, review, escalate, or ask the team for input. | The proposal is blocked. It cannot be cleared automatically and goes to a person. |
|
| P4 · A reason is given Blocking | The proposal explains itself in words, so a reviewer can see why the AI judged it this way. | The proposal is blocked. A decision with no stated reason is never accepted automatically. |
|
| P5 · It rests on documents that are in force today Blocking | Every control the proposal relies on points to a controlled document, and that document has a version in force today. | The proposal is blocked. Work is never judged against a procedure that is missing or no longer in force. |
|
| P6 · Supporting text was found Warning | At least one passage from the mapped documents bears on the record. | A warning is recorded. The reviewer sees that the AI’s view is not backed by a quoted passage. |
|
| P7 · Formality matches the risk Warning | The formality grade (A to D) is not below what the risk level (1 to 4) requires. | A warning is recorded and a person must review it. |
|
| P8 · The AI did not try to lower the bar Warning | The AI does not recommend clearing something that the fixed risk rules say a person must look at. | A warning is recorded. The fixed rules prevail and a person reviews it regardless of what the AI said. |
|
Rules for assistant answers
Applied to every answer before the auditor sees it.
| Rule | What it checks | If it fails | Proposed regulation links |
|---|---|---|---|
| A1 · Every document it names is cited Blocking | Any procedure the answer mentions exists in the library and is shown as a source with its section. | The answer is withheld and replaced with a safe message. The auditor never sees an unsourced procedure claim. |
|
| A2 · Every version it cites is the one in force Blocking | No answer relies on a superseded version, or on a version approved for a future date that has not started. | The answer is withheld and replaced with a safe message. |
|
| A3 · Quotations are word for word Blocking | Every quoted passage appears exactly as written in the cited section of the cited version. | The answer is withheld and replaced with a safe message. |
|
| A4 · Records it mentions exist Blocking | Every assessment code in the answer (for example ASM-0004) is a real record on this platform. | The answer is withheld and replaced with a safe message. |
|
| A5 · No links to the outside Blocking | The answer contains no web addresses. Everything it says comes from inside the validated environment. | The answer is withheld and replaced with a safe message. |
|
Assurance lab: the test bench
These are simulated bad outputs, written to be wrong in one specific way. Each one is run through the live rules. 17 of 17 were handled exactly as expected. If a rule is ever weakened, a case here stops being caught and the automated tests fail.
A sound proposalAI proposalAs expected
Severity 2, occurrence 2, detection 2 (RPN 8). Confidence 90%. Recommends clearing it, with a stated reason and a current SOP.
Checked, passedAll 8 Assurance checks on this proposal
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade B2 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
A severity score of 14AI proposalAs expected
Severity 14 (the scale only goes to 4). Everything else looks normal.
Checked, blocked3 of 8 Assurance checks failed
- ✕P1 · Scores are on the defined scalesOut of range: severity is 14, must be 1 to 4.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- !P7 · Formality matches the riskNot evaluated because the scores are invalid.
- !P8 · The AI did not try to lower the barNot evaluated because the scores are invalid.
Rule set v1.0.0, judged on 2026-10-26. See the rules
Confidence of 140%AI proposalAs expected
Confidence 1.4, recommends clearing it.
Checked, blocked1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✕P2 · Confidence is a real percentageConfidence is 1.4, which is not between 0% and 100%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade B2 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
A recommendation the platform does not haveAI proposalAs expected
Recommends “approve and release”.
Checked, blocked1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✕P3 · Recommendation is one the platform allows“approve and release” is not one of clear, review, escalate, request_input.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade B2 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
No reason givenAI proposalAs expected
Recommends clearing it. Reason: “ok”.
Checked, blocked1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✕P4 · A reason is givenNo reason, or too short to be a reason, was given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade B2 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It cites a procedure that does not existAI proposalAs expected
Relies on “SOP-XX-999 Rapid Release Procedure”.
Checked, blocked1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✕P5 · It rests on documents that are in force today“SOP-XX-999 Rapid Release Procedure” is not a document in the library.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade B2 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
Nothing in the documents backs it upAI proposalAs expected
A routine proposal, but no passage from the mapped documents was found to support it.
Checked, with warnings1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- !P6 · Supporting text was foundNo passage in the mapped documents was found for this record.
- ✓P7 · Formality matches the riskGrade B2 is formal enough for the risk.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It tries to clear a high-risk itemAI proposalAs expected
Severity 4, occurrence 4, detection 3 (RPN 48). Recommends clearing it with 95% confidence.
Checked, with warnings1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 95%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “clear”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- ✓P7 · Formality matches the riskGrade D4 is formal enough for the risk.
- !P8 · The AI did not try to lower the barThe AI recommended clearing it, but the fixed rules say a person must look (RPN 48, grade D4). The rules prevail.
Rule set v1.0.0, judged on 2026-10-26. See the rules
High risk, informal gradeAI proposalAs expected
Severity 4, occurrence 4, detection 3, but uncertainty, importance and complexity all scored 0, which gives the least formal grade.
Checked, with warnings1 of 8 Assurance checks failed
- ✓P1 · Scores are on the defined scalesAll six scores are whole numbers inside their scales.
- ✓P2 · Confidence is a real percentageConfidence is 90%.
- ✓P3 · Recommendation is one the platform allowsThe recommendation is “review”.
- ✓P4 · A reason is givenA reason is given.
- ✓P5 · It rests on documents that are in force todayAll 1 named control(s) have a version in force.
- ✓P6 · Supporting text was found1 supporting passage(s) found.
- !P7 · Formality matches the riskGrade A4 is less formal than risk level 4 requires.
- ✓P8 · The AI did not try to lower the barThe AI’s recommendation does not try to go below what the fixed rules require.
Rule set v1.0.0, judged on 2026-10-26. See the rules
A well-sourced answerAssistant answerAs expected
Here is what the procedure says: • SOP-QA-007 v6.0 §4.2, Storage and temperature excursions: "Any storage or temperature excursion outside validated limits requires the affected stock to be quarantined immediately."
Checked, passedAll 5 Assurance checks on this answer
- ✓A1 · Every document it names is citedSOP-QA-007 named and cited.
- ✓A2 · Every version it cites is the one in forceSOP-QA-007 v6.0 in force.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It quotes the old, superseded versionAssistant answerAs expected
Here is what the procedure says: • SOP-QA-007 v5.0 §4.2, Storage and temperature excursions: "Any storage or temperature excursion outside validated limits requires the affected stock to be placed on hold."
Checked, blocked1 of 5 Assurance checks failed
- ✓A1 · Every document it names is citedSOP-QA-007 named and cited.
- ✕A2 · Every version it cites is the one in forceSOP-QA-007 v5.0 has been superseded.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It relies on a version that has not started yetAssistant answerAs expected
Changes to AI models need re-validation: • SOP-QA-015 v5.0 §4.5, Changes to AI models: "A change to the model, its instructions or its rules is a change to a validated system."
Checked, blocked1 of 5 Assurance checks failed
- ✓A1 · Every document it names is citedSOP-QA-015 named and cited.
- ✕A2 · Every version it cites is the one in forceSOP-QA-015 v5.0 is approved but not yet in force.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It slightly rewords a quotationAssistant answerAs expected
Per SOP-QA-007 v6.0 §4.2: "An impact assessment must be completed within ten working days before any stock is released."
Checked, blocked1 of 5 Assurance checks failed
- ✓A1 · Every document it names is citedSOP-QA-007 named and cited.
- ✓A2 · Every version it cites is the one in forceSOP-QA-007 v6.0 in force.
- ✕A3 · Quotations are word for word“An impact assessment must be completed within ten working da…” is not word for word in any cited section.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It names a procedure without citing itAssistant answerAs expected
According to SOP-QA-012, every CAPA must be closed in thirty days.
Checked, blocked1 of 5 Assurance checks failed
- ✕A1 · Every document it names is citedSOP-QA-012 is named but not cited as a source.
- ✓A2 · Every version it cites is the one in forceNo document version is relied on.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It invents a procedureAssistant answerAs expected
SOP-QA-099 allows stock to be released early with a verbal approval.
Checked, blocked1 of 5 Assurance checks failed
- ✕A1 · Every document it names is citedSOP-QA-099 is not in the library.
- ✓A2 · Every version it cites is the one in forceNo document version is relied on.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It invents a recordAssistant answerAs expected
ASM-0999 was signed off by the QA head last week.
Checked, blocked1 of 5 Assurance checks failed
- ✓A1 · Every document it names is citedNo procedure is named.
- ✓A2 · Every version it cites is the one in forceNo document version is relied on.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✕A4 · Records it mentions existASM-0999 does not exist.
- ✓A5 · No links to the outsideNo web addresses.
Rule set v1.0.0, judged on 2026-10-26. See the rules
It sends the reader to a web pageAssistant answerAs expected
See https://example.com/gmp-guidance for the current rule.
Checked, blocked1 of 5 Assurance checks failed
- ✓A1 · Every document it names is citedNo procedure is named.
- ✓A2 · Every version it cites is the one in forceNo document version is relied on.
- ✓A3 · Quotations are word for wordEvery quotation matches the cited text.
- ✓A4 · Records it mentions existNo record is mentioned.
- ✕A5 · No links to the outsideContains a web address: https://example.com/gmp-guidance.
Rule set v1.0.0, judged on 2026-10-26. See the rules