ForgeSOP CAPA vs IQVIA SmartSolve CAPA Management
ForgeSOP CAPA
forgesop.comIQVIA SmartSolve CAPA Management
iqvia.comSide by side
| Figure | ForgeSOP CAPA | IQVIA SmartSolve CAPA Management |
|---|---|---|
| Price from | $7/mo | — |
| Free plan | — | — |
| Free trial | Yes | — |
| Open source | — | — |
| Web | Yes | Yes |
| iOS | Yes | — |
| Android | Yes | — |
| API | — | Yes |
| Plans published | 2 | 1 |
| Spec score · Corrective and Preventive Action Software | 8.0 (#6) | 6.9 (#16) |
| Intended users | The maker positions ForgeSOP for teams running on process and identifies manufacturing, construction, retail, transportation and logistics, and utilities as industries. | The product page identifies medical device, pharmaceutical, and diagnostic companies as its target organizations. |
| Purpose | ForgeSOP CAPA manages corrective and preventive actions with root-cause analysis, owned action plans, evidence, signatures, and effectiveness checks. | An AI-enabled, risk-based solution for life sciences organizations to manage corrective and preventive actions, reduce regulatory risk, and support compliance. |
Plans
IQVIA SmartSolve CAPA Management
- IQVIA SmartSolve CAPA ManagementPriced on request
In their own words
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.
IQVIA SmartSolve CAPA Management
IQVIA SmartSolve CAPA Management is a paid, risk-based system for corrective and preventive action in life sciences organizations. Teams can record problems, define and monitor corrective and preventive actions, and review each CAPA’s effectiveness. CAPAs may stand alone or connect with Deviation Management, while listed quality connections include Complaint, Document, Change, Event, Audit, and Nonconformance Management. SmartSolve APIs connect CAPA data with CRM, ERP, LIMS, MES, and PLM systems. AI assistance can draft summaries using precedent information. Issues can enter through forms or automated integration and be assessed with RPN scoring. Reporting, trend analysis, Pareto charts, and Microsoft Power BI-based Quality Intelligence support risk review. Automated notifications, escalation, and milestone tracking support closure. Listed controls include role-based security, audit trails, and electronic signatures. IQVIA says SmartSolve is ISO 27001 and ISO 9001 certified and built on Microsoft Azure. It is available through web and API platforms, with pricing on request.