What problem does it solve? Operating a validated GxP quality system like Veeva Vault QMS is dangerous because nearly every meaningful write is a regulated act with a permanent audit trail: lifecycle state changes fire automation, e-signatures are irrevocable 21 CFR Part 11 acts, and wrong dispositions can miss statutory reporting deadlines. This Skill classifies every Vault QMS action so consequential ones pause for human approval. ## Core Features & Use Cases - Action Classification: Sorts Vault QMS operations into read, reversible write, committing write, and destructive tiers with gating rules for each. - Quality Event Expertise: Covers deviations, CAPAs with effectiveness checks, complaints and reportability, change control, audits, and OOS/OOT investigations across object types and lifecycles. - Recovery Playbooks: Provides correct-forward recovery patterns for premature closures, wrong dispositions, erroneous signatures, and cross-vault pushes. - Use Case: When asked to close a CAPA, the Skill recognizes closure before the effectiveness check as a destructive premature closure and routes it for named human approval instead of executing it. ## Quick Start Ask the agent to classify a deviation as major and advance it to investigation in Veeva Vault QMS, and it will gate the committing state change for approval first.
