pHKapa vs V5 Ultimate CAPA

pHKapa manages corrective and preventive actions for teams investigating complaints, defects, and nonconformities. It moves issues through registration, review, planning, implementation, and verification, and supports corrective, preventive, and other action types with effectiveness checks. Root-cause analysis includes the 5 Whys and another schema. Automated workflows and ticket history record who verifies, modifies, or closes tickets. Internal and email notifications are included; users can attach documents and comment, while the Community package also offers CSV export and ticket reports. pHKapa is available as self-hosted software or as a Cloud service hosted on the maker’s servers. Community and Full Pack require a web server, PHP 7, and MySQL 5 or higher. Community is free; Full Pack costs $48 once. Cloud costs €65 per month and includes 5GB storage, daily backups, advanced HTTPS protection, and a 30-day trial. The maker describes design, manufacturing, quality improvement, and engineering teams as users.

V5 Ultimate CAPA manages corrective and preventive actions through structured root-cause workflows, scheduled effectiveness checks, and signed closure. Teams can use 5-whys, fishbone (Ishikawa), or Pareto methods. The module is modeled against 21 CFR Part 820.100, ICH Q10/Q9, and ISO 13485:2016 requirements, and connects CAPA work with V5’s MES, WMS, and QMS on one immutable batch record. Regulated writes and signatures enter an immutable audit table with the operator, timestamp, IP, reason, and before-and-after hash. V5 offers signed webhooks, a JSON REST interface, and CSV bulk import, with integrations including SAP Business One, NetSuite, LabWare, Power BI, and others. Deployment options are Lovable Cloud or containerized on-premises hosting that can operate air-gapped. The app tier runs in Linux OCI containers, not as a native Windows application. A free seven-day trial includes a non-GxP sandbox with sample data. Express costs $110 a month per concurrent seat; Professional is 160.00 USD and Enterprise 200.00 USD on the same basis. Annual billing saves 15%.