GxP / GMP Annex 11

A regulated manufacturer depends on systems that behave predictably and on records that stay complete. An assistant near batch or laboratory data enters that same expectation. This starter limits what such an assistant can see and produce, and it supplies evidence inputs for review.

Annex 11 speaks about a validated system, and the data integrity principles speak about the records inside it. A validation owner or a quality unit reaches for this starter when an assistant meets either one.

A study reference joins the user and organization claims that the identity check requires. That third value ties a request to a defined scope, which matters when a batch or a study is the unit of review. Patient, subject and investigator identifiers are masked before the prompt leaves the gateway.

Prompts about trial results, adverse events, batch records and deviations are refused. The intent is to keep regulated records out of a general prompt path until a validated flow exists for them.

Answers must cite sources at a confidence floor of 0.90, and an unverified citation is flagged while the answer still returns. Raise that to a block when your quality unit requires it. Combined quality must reach 0.85 and accuracy must reach 0.90.

No model text leaves this configuration without a qualified person in the loop. The review stage stops each response and records an escalation, so batch release and deviation work never return unsupervised. Neither does an ordinary question, which is the practical cost of the setting. Periodic review, backup verification and supplier qualification stay outside the gateway. The request marker only shows that an evaluation happened, and it manages no retention.