Situation and intended use
An assistant summarizes a deviation and proposes a category. A proposed extension would create investigation tasks automatically. Approved severity, root cause, disposition, and closure remain decisions of authorized personnel.
What changes when actions are added?
An incorrect suggestion can mislead a reviewer. An incorrect action can also modify a workflow, notify the wrong people, expose information, create duplicate tasks, or leave a partially completed transaction. The assurance boundary must include tool permissions and failure recovery.
Proposed controls
Limit tools to approved actions and destinations. Require human confirmation where defined by the process. Validate structured action parameters. Prevent duplicate execution. Log action requests, approvals, actual outcomes, and errors. Provide a safe stop and an owned recovery process. Keep production approval and closure permissions outside the assistant’s access.
Worked tests
Challenge an ambiguous deviation, missing product information, duplicate submission, tool timeout, unauthorized destination, manipulated source instructions, and a retry after partial completion.
Completed test extract — fictional: “AG-T09 simulates a timeout after task creation. On retry, the agent queries the transaction state and does not create a second task for the same approved request. The review record identifies the original action and recovery result.”
Worked outcome
The assistant correctly summarizes most cases but creates duplicate tasks after timeout. The team may continue evaluating read-only suggestions under the approved pilot boundary, but action capability remains disabled until duplicate prevention and recovery are supported by evidence.
Monitoring and reassessment
Review incorrect categories, unauthorized action attempts, repeated failures, reviewer corrections, tool changes, permission changes, and incident patterns. A model update can affect action selection even when the tool code stays the same.
Challenge: Can a prompt stating “never close deviations” establish the boundary?
Worked answer: Use technical permissions and workflow controls that prevent closure. The prompt can communicate intent but should not be the only barrier to a consequential prohibited action.
Limitations and unresolved questions
A read-only pilot does not justify enabling workflow actions. Idempotency, recovery and authority checks need separate evidence before expansion.
Relevant regulations and guidance
These sources apply within their stated scope. The suggested worksheet fields, test designs and fictional decisions are practitioner recommendations, unless a source requirement is expressly identified. Completing a template does not establish compliance.
Computer Software Assurance for Production and Quality Management System Software ↗
Regulatory guidance / GMP guideline · United States · February 2026
Scope: Medical-device manufacturers assuring software used in production or their quality management system.
Relevance: For medical-device production or QMS software, supports selecting assurance activities from intended use, risk and available evidence. It is nonbinding guidance and does not determine other sectors’ obligations.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →EudraLex Volume 4, Annex 11 — Computerised Systems ↗
Regulatory guidance / GMP guideline · European Union · January 2011 revision
Scope: Computerised systems supporting activities in the applicable EU pharmaceutical GMP context.
Relevance: For computerised systems used in EU GMP activities, informs lifecycle, supplier and record controls. Confirm applicability to the actual activity; the example does not establish it.
Status: Final / published · Checked 2026-09-21
The Commission index confirms the January 2011 operative revision. The linked PDF could not be retrieved in this check; retained detailed section mappings need review against an authorized copy.
Read source details and applicability →Artificial Intelligence Risk Management Framework (AI RMF 1.0) and NIST AI 600-1 ↗
Industry guidance / framework · United States · AI RMF 1.0 (2023); GenAI Profile (2024)
Scope: Cross-sector AI governance and risk management, including generative AI.
Relevance: A voluntary framework for describing AI risks, evaluation and ongoing management. Its suggested practices are not regulatory requirements.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
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Resource: Agentic deviation triage: control actions as well as answers
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