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- Greenlight Guru
On the recordRead 9 Oct 202614 facts
Greenlight Guru
Indianapolis, Indiana, United States
Plans and prices
Greenlight Guru Clinical Essentials
$9,000a year
Up to 1 ongoing study · Up to 10 sites · 100GB file vault · eConsent and custom reports/notifications are add-ons
Read 9 Oct 2026 · greenlight.guru
Greenlight Guru eQMS
$12,000a year
Price depends on products and capabilities; implementation priced separately
Read 9 Oct 2026 · greenlight.guru
Greenlight Guru Clinical Plus
Priced on request
Everything in Essentials · Up to 3 ongoing studies · Up to 30 sites
Read 9 Oct 2026 · greenlight.guru
Greenlight Guru Clinical Professional
Priced on request
Everything in Essentials and Plus · Up to 5 ongoing studies · Up to 50 sites · eConsent
Read 9 Oct 2026 · greenlight.guru
On the record
- AI privacy
- The company states that customer data is not used to train AI models and that its AI management system is certified to ISO 42001.greenlight.guru · read 9 Oct 2026
- Clinical EDC
- The Clinical product captures compliant clinical data and supports studies, adverse event tracking, randomization, and multi-language forms.greenlight.guru · read 9 Oct 2026
- Company history
- The company says the initial idea for Greenlight Guru arose in 2006 and names Jon Speer and co-founder David DeRam as its developers.greenlight.guru · read 9 Oct 2026
- Data portability
- Customers can export quality records and clinical study data in standard formats without buying a separate services engagement.greenlight.guru · read 9 Oct 2026
- Deployment
- Greenlight Guru is cloud-based, accessed through a web browser, runs on Amazon Web Services, and requires no customer hosting.greenlight.guru · read 9 Oct 2026
- Design controls
- The product supports requirements, reviews, verification, validation, design history files, and links between risk controls and requirements.greenlight.guru · read 9 Oct 2026
- Implementation
- Most standard eQMS implementation engagements take two to eight weeks, depending on scope.greenlight.guru · read 9 Oct 2026
- Integration limit
- Most pre-built integrations run on a schedule or trigger rather than continuous real-time sync, and customers build and maintain their own API connections.greenlight.guru · read 9 Oct 2026
- Integrations
- Pre-built integrations include Jira, GitHub, Google Drive, and Microsoft Office for the web; the REST API supports custom connections.greenlight.guru · read 9 Oct 2026
- Purpose
- Greenlight Guru provides quality management, product development, and clinical evidence software designed for medical device companies.greenlight.guru · read 9 Oct 2026
- Quality management
- Its eQMS connects design, risk, documents, training, suppliers, and quality events and is described as aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304.greenlight.guru · read 9 Oct 2026
- Security
- 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.greenlight.guru · read 9 Oct 2026
- Support
- Subscriptions include a dedicated customer success manager, training resources, and support; implementation is quoted separately.greenlight.guru · read 9 Oct 2026
