Pharma Deviation & CAPA Investigation Playbook

Turn a raw GMP deviation record into an inspector-defensible investigation inside the 30-day clock: classified severity with uplift rules, a root cause that never stops at operator error, a batch disposition a Qualified Person would sign, a CAPA with effectiveness checks that can fail, and a 483-style red-team of the draft before it enters the QMS. Run in your site's approved LLM with de-identified data.

A 5-step agentic workflow pack for operations built to run with ChatGPT, Claude, and Gemini. Open the Markdown files, fill the variables, and paste into your model. Most buyers get a reviewable result in about 15 minutes.

• Classify the deviation minor, major or critical against explicit anchors and uplift rules, with a recurrence screen run before any root cause work
• Reconstruct the timeline and run an Ishikawa and why-chain pass against an eight-category GMP failure-mode catalog where human error is never a terminal answer
• Rank probable causes with evidence for and against, a confidence anchor, and a verification test the site can run inside the investigation clock
• Extend scope to every batch, product, line and piece of equipment that shares the condition, and explain why a prior CAPA failed when the event is a recurrence
• Assess batch, other-batch, validated-state and stability impact and land on one of five disposition anchors with a justification written for a Qualified Person's signature
• Draft corrections, corrective and preventive actions ranked on a six-level effectiveness hierarchy, each tied to a cause and closed only on measurable effectiveness criteria
• Red-team the assembled draft against 21 CFR 211.192 and a fourteen-item weak-investigation catalog, with observation-style write-ups and a ready / revise / do-not-approve verdict