AI Lead CAPA vs CAPA Engine

AI Lead CAPA is software for pharmaceutical quality investigations, guiding work from problem statement and containment through root-cause analysis, corrective and preventive actions, verification, and sign-off. Review gates apply at every stage. An investigation coach asks clarifying questions and rejects vague responses; comparable-case retrieval helps examine recurrence, precedent, and whether earlier actions held. Corrective actions are checked against a confirmed root cause, and an investigator must review the work before CAPA creation. Deviations, audit findings, and complaints share one engine with configurable approval routes. Source records and evidence link to investigations, while an audit trail records decisions. Only people can approve or sign, and the system records when a named person accepts, edits, or replaces an AI suggestion. Lead AI describes on-premise deployment in a dedicated in-country environment or within the customer’s infrastructure. Elyndra 1.0 supports English and Bahasa Indonesia. Pricing is on request.

CAPA Engine is a web tool for structuring nonconformance reviews into root cause analysis, corrective actions, effectiveness checks, and investigation intelligence tied to a regulatory framework. Root cause analysis uses Ishikawa and 5-Why methods, ranks probable causes, evaluates evidence, and sets out an investigation plan. Corrective action plans cover containment, correction, systemic, and preventive actions with regulatory clause references. Effectiveness checks can specify quantitative acceptance criteria, monitoring periods, and pass/fail logic. The product describes a reasoning graph that records evidence for and against causes with confidence scores, plus an intelligence panel for failure patterns, auto-FMEA drafts, and recurrence prediction scoring. It exports CAPA, 8D, SCAR, and Deviation reports in Word and PDF. Listed industries include medical devices, pharma and biotech, aerospace and defense, automotive, food and beverage, and general manufacturing. Frameworks include ISO 13485, 21 CFR 820, AS9100D, IATF 16949, ISO 14971, IEC 62304, ICH Q10, SQF, BRC, FSSC 22000, ISO 9001, and NADCAP. A free option provides one root cause analysis; a one-time CAPA costs 39.00 USD. Generated output should be reviewed by qualified personnel before use in decisions.