Adaptive FRACAS vs AssurX CAPA Software

Adaptive FRACAS, offered through CAPA Manager, records failures involving products, processes, tests, field use, warranties, or suppliers and follows investigations through corrective action, verification, and closure. Teams can use methods such as 5 Whys, Ishikawa, 8D, RCCA, A3, DMAIC, PDCA, and FMEA-style work. Reports and dashboards surface recurring causes and failures, late actions, and improvement opportunities. Supplier users can join controlled investigations while the customer team manages actions, evidence, and closure. Listed controls include role permissions, two-factor authentication, device approval, and restricted-access records. An optional API gives read-only access to approved records and actions; it cannot change or close records. CAPA-Basic is free for two users and two linked accounts. Paid plans start at $199.45 a month for CAPA-5; premium features include attachments, PDF reports, exports, and complete audit history. The product is available on Android, iOS, and web, with API access. The maker says it supports auditable workflows for regulated teams but does not certify organizations.

AssurX CAPA Software manages corrective and preventive actions from incident capture through investigation, assigned work, effectiveness checks, and closure. CAPAs can begin with audits, deviations, complaints, nonconformances, incidents, or risk assessments. Structured root-cause methods include 5 Whys, fishbone diagrams, 8D, and FMEA. Configurable workflows handle ownership, due dates, reminders, escalation, and approvals. Records can connect CAPAs with related issues, risks, changes, and supporting documents while preserving controlled records and audit trails. The software includes electronic signatures and a secure, time-stamped archive of record changes. AssurX lists support for FDA requirements and alignment with ISO and GxP requirements, including 21 CFR Part 820 and Part 11, EU MDR, ISO 9001, ISO 13485, and EU IVDR. Cloud and on-premises licensing use the same software, with an open API and integrations for ERP, PLM, MES, LIMS, CRM, and CMMS systems. Pricing is available on request.