AI Lead CAPA

What AI Lead CAPA is

AI Lead CAPA is software for pharmaceutical quality investigations, guiding teams through problem statements, containment, root-cause analysis, corrective and preventive actions, verification, and sign-off. Review gates apply at each stage. Its investigation coach asks follow-up questions and rejects vague answers, while comparable-case retrieval helps investigators consider recurrence, prior decisions, and whether earlier actions worked. Corrective actions are checked against a confirmed root cause, and an investigator must review the work before CAPA creation. Deviations, audit findings, and complaints use a shared engine with approval routes that can be configured around a customer's process. The system links source records and evidence to investigations and records decisions in an audit trail. Only people can approve or sign; the system records when a named person accepts, edits, or replaces a suggestion. Lead AI says client data is used at query time and not to train its model. It describes deployment on-premise or inside a customer's infrastructure. Pricing is on request. Elyndra 1.0 supports quality and manufacturing work in English and Bahasa Indonesia.