AssurX CAPA Software vs ForgeSOP CAPA
AssurX CAPA Software
assurx.com
ForgeSOP CAPA
forgesop.comSide by side
| Figure | AssurX CAPA Software | ForgeSOP CAPA |
|---|---|---|
| Price from | — | $7/mo |
| Free plan | — | — |
| Free trial | — | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| iOS | — | Yes |
| Android | — | Yes |
| API | Yes | — |
| Self-hosted | Yes | — |
| Plans published | 1 | 2 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 8.0 (#6) |
| Company history | AssurX says it was incorporated in California in March 2000. | ForgeSOP says it was founded in 2021 by two business owners and reports being trusted by 500+ businesses worldwide. |
| Founded | 2000 | 2021 |
| Intended users | AssurX describes its platform as built for organizations in highly regulated environments and names industries including medical devices, pharma, biotech, food, electronics, aerospace, energy, and manufacturing. | The maker positions ForgeSOP for teams running on process and identifies manufacturing, construction, retail, transportation and logistics, and utilities as industries. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | ForgeSOP CAPA manages corrective and preventive actions with root-cause analysis, owned action plans, evidence, signatures, and effectiveness checks. |
| Root cause analysis | It supports structured root cause analysis, including 5 Whys and fishbone methods. | The RCA editor supports 5-Whys, fishbone, or free-form analysis, with evidence files content-hashed to the record. |
Plans
In their own words
AssurX CAPA Software
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.
ForgeSOP CAPA
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.