GxP Genie

Accelerate critical qualification, validation, and compliance processes while ensuring FDA compliance with GxP Genie, a leadingIntelligent Digital Validation Platform.

Unlike traditional document-centric validation solutions, GxP Genie embraces the risk based computer software assurance guidance from the FDA to promote critical thinking and agility.

GxP Genie offers a seamless solution for creating, reviewing, approving, and executing validation artifacts and activities. Its user-friendly interface fosters real-time collaboration, ensuring compliance with regulation.

• 21 CFR PART 11
• ANNEX 11

Collaborate on:

• Validation plans
• Requirements
• Risk assessments
• Testing
• Summary reports

Say goodbye to time-consuming validation processes and embrace a critical thinking approach. Utilize comprehensive reports and data-driven analytics to gain valuable insights and make informed decisions.

With its customizable workflows and easy integration with existing systems, GxP Genie adapts to your specific business.