AssurX CAPA Software vs Centra CAPA Management

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.

Centra CAPA Management is the corrective and preventive action module in Centra’s web-based quality management system. It collects nonconformities from complaints, audits, production deviations and supplier issues, then supports root-cause analysis, corrective-action planning and improvement monitoring. Named analysis methods are 5 Why, Ishikawa (Fishbone) and Pareto. Teams can assign owners, set target dates, split work into tasks and see delays. Effectiveness checks look for recurrence and use performance data and audit evidence. CAPA records can link to products, processes, equipment, suppliers, customers, documents and audit findings. The surrounding QMS includes document records, audits, change management, training and qualification, calibration, complaints and risk management. Centra describes access as web-based and mobile compatible. It says the QMS operates in compliance with ISO, GMP and GLP requirements. Pricing is on request, with a demo and tailored quote process.