ForgeSOP CAPA vs pHKapa

ForgeSOP CAPA manages corrective and preventive actions from the initial issue through analysis, assigned work, approval, and a check that the remedy held. Deviations, audit findings, incidents, and risk treatments can open a CAPA linked to their source records. The analysis editor supports 5-Whys, fishbone, and free-form methods; evidence files are content-hashed to the record. Each corrective or preventive action can have an owner, due date, and verification criteria, and is tracked as an audit-trailed task. Closing requires a re-authenticated electronic signature, and an assessor cannot approve their own closure. A scheduled effectiveness check must confirm the fix held. A PDF binder brings together intake, analysis, actions, signatures, and the hash chain. ForgeSOP describes workflows shaped for ISO 9001 §10.2, ISO 13485, and 21 CFR Part 11, while noting that customers must validate formal Part 11 compliance. It runs on Android, iOS, and the web. Pro costs $7 a month, billed at $7 per user per month, and includes a 14-day trial; Enterprise pricing is custom.

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.