OpenClinica vs SimplerQMS
OpenClinica
openclinica.comSimplerQMS
simplerqms.comSide by side
| Figure | OpenClinica | SimplerQMS |
|---|---|---|
| Price from | $750/mo | $1,458.33/mo |
| Free plan | — | Yes |
| Free trial | Yes | Yes |
| Open source | Yes | — |
| Web | Yes | Yes |
| Windows | Yes | — |
| macOS | Yes | — |
| Linux | Yes | — |
| iOS | Yes | — |
| Android | Yes | — |
| API | Yes | Yes |
| Self-hosted | Yes | — |
| Plans published | 4 | 3 |
| Spec score · Life Sciences Software | 8.8 (#1) | 7.7 (#10) |
| Compliance | The company states its platform is ICH GCP E6 (R2), 21 CFR Part 11, HIPAA, and GDPR compliant, and SOC 2 Type II and ISO 27001 certified. | The company says SimplerQMS A/S is ISO 13485:2016 and ISO/IEC 27001:2022 certified, and that its software complies with FDA 21 CFR Part 11. |
| Headquarters | Needham, Massachusetts, USA | Copenhagen, Denmark |
| Intended users | The company says it focuses on small to midsize sponsors, CROs, and academic research teams. | The product is intended for life science organizations, including medical device, pharmaceutical and biotech, laboratory, and CRO/CMO companies. |
Plans
OpenClinica
- Launch$750 a month
- Core$3,000 a month
- Advanced$3,750 a month
- Enterprise & AcademicPriced on request
SimplerQMS
- Viewer licenseFree
- Starter$17,500 a year
- Team & EnterprisePriced on request
In their own words
OpenClinica
OpenClinica has no write-up on Specifiction yet; its figures are above.
SimplerQMS
SimplerQMS is a cloud-based electronic quality management system for life science organizations, including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO companies. Its modules cover document control, change management, training, CAPA, audits, design control, supplier and equipment management, and risk management. The platform automates document reviews, approvals, and routing, and links records to support traceability. It provides electronic signatures and time-stamped audit logs that the company says comply with FDA 21 CFR Part 11 and EU GMP Annex 11. Microsoft 365 integration lets users edit Word, Excel, and PowerPoint files and save them to the system; other listed integrations include ERP, CRM, PLM, and WMS, with an API for scripting environments. Single sign-on is available through Microsoft Entra ID and Google Workspace. Subscriptions include implementation, validation, migration, live training, hosting, templates, and 24/7 emergency phone support. A free Viewer license offers unlimited users read-only access. Starter costs $17,500 a year for up to 15 users; pricing for Team & Enterprise is by request.