Simplifying MedTech Regulatory Compliance

Designed and developed in compliance with the PIC/S Guidance, PI-011-3 Good Practices for Computerized Systems in Regulated “GxP” Environments, with software validation based on IEC 62304.

MDR Compliance with ready-to-use templates

Streamline the process of documentation and compliance with Greenlight Guru Clinical’s SOP templates and validation templates.

14155:2020 Compliance

We ensure that you can be compliant with the industry latest standard on GCP for Medical Devices.

Clinical Data Management SOPs

We deliver ready-to-use SOP templates that you can customise to your own QMS or study protocol.

Ole Kjeldsen
National Technology & Security Officer - Microsoft Denmark

The innovative Greenlight Guru Clinical, built on our cloud-technology, enables collaboration with sensitive data across R&D projects and geography. This results in better outcomes for patients and organizations.

All your data safe in one place

Greenlight Guru Clinical is designed to protect your data - by following industry leading standards on security, encryption, and access control.

Read our Security & Service Level Statement
  • Two-step verification

    Prevent unauthorized access to your account and enable extended validation for critical study actions.

  • Permission-based access control

    Increase security and improve compliance with regulatory requirements with extensive user permission control.

  • Extensive system audit logging

    Track changes and every action on both user and study level.

Comply with international standards

Greenlight Guru Clinical simplifies regulatory compliance for ISO 14155 (GCP), FDA 21 CFR Part 11, GDPR, and HIPAA by offering ready-to-use QA templates, system modules, and guidance documents.

Read the GCP, FDA Part 11, and HIPAA Compliance Statement