AssurX CAPA Software vs Greenlight Guru
AssurX CAPA Software
assurx.comGreenlight Guru
greenlight.guruSide by side
| Figure | AssurX CAPA Software | Greenlight Guru |
|---|---|---|
| Price from | — | $750/mo |
| Free plan | — | — |
| Free trial | — | — |
| Open source | — | — |
| Web | Yes | Yes |
| API | Yes | Yes |
| Self-hosted | Yes | — |
| Plans published | 1 | 4 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 7.4 (#13) |
| Company history | AssurX says it was incorporated in California in March 2000. | The company says the initial idea for Greenlight Guru arose in 2006 and names Jon Speer and co-founder David DeRam as its developers. |
| Integrations | AssurX says it integrates with ERP, PLM, MES, LIMS, CRM, and CMMS systems, and names SAP, Salesforce, Oracle, PTC/Windchill, and ServiceNow among examples. | Pre-built integrations include Jira, GitHub, Google Drive, and Microsoft Office for the web; the REST API supports custom connections. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | Greenlight Guru provides quality management, product development, and clinical evidence software designed for medical device companies. |
| Security | AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant, and uses 256-bit encryption for data in transit and at rest. | Greenlight Guru says it is certified to ISO 27001, ISO 42001, ISO 9001, and SOC 2, and that subscriptions include role-based security and encryption. |
| Support | Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours. | Subscriptions include a dedicated customer success manager, training resources, and support; implementation is quoted separately. |
Plans
Greenlight Guru
- Greenlight Guru Clinical Essentials$9,000 a year
- Greenlight Guru eQMS$12,000 a year
- Greenlight Guru Clinical PlusPriced on request
- Greenlight Guru Clinical ProfessionalPriced on request
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.
Greenlight Guru
Greenlight Guru has no write-up on Specifiction yet; its figures are above.