GxP Genie


GxP Genie


Introducing GxP Genie, the game-changing tool for Intelligent Validation in Life Sciences. This innovative software streamlines the CSA/CSV lifecycle management process, freeing time to apply critical thinking skills.


Utilize our extensive library of Life Sciences industry proven documents for both MedTech and Pharma to accelerate your journey toward strategic excellence.

  • Automate the tedious aspects of validation, so you can focus on creativity and strategic thinking.
  • Quickly iterate and refine documentation without starting from scratch.


Our Generative AI engine gives instant and grounded feedback on your validation documentation to improve quality and compliance.

  • Integrate seamlessly into Agile workflows, to create documentation that supports iterative development and continuous improvement.


Designed with simplicity in mind, GxP Genie’s interface is easy to navigate, ensuring a smooth experience for users of all levels.

  • Utilize pre-defined prompts and templates to fit industry standards and project needs.

Intuitive & Configurable

GxP Genie offers a seamless solution for creating, tracking, and documenting requirements, validation protocols, test scripts, deviations, and change control activities. Its user-friendly interface fosters real-time collaboration and ensures compliance with regulatory requirements.

Experience the efficiency, accuracy, and compliance benefits of GxP Genie. Say goodbye to time-consuming manual processes and embrace a paperless approach to validation. 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 is adaptable to your specific business needs. Unleash the full potential of Paperless Intelligent Validation. Schedule a personalized demonstration today to witness how GxP Genie will transform your validation processes and revolutionize your industry.


GxP Genie is an innovative chatbot that streamlines the computer system validation process. It empowers quality team members, project managers, and business analysts, transforming their ideas into clear, actionable, and precise documentation. Here’s how GxP Genie can revolutionize your workflow:

Experience the simplicity of generating Requirements:

Describe your product vision, and GxP Genie will help you break it down into detailed functional requirements. Ensure completeness and clarity by prompting you with relevant questions and industry best practices.

Create Compelling User Stories:

Turn user needs into engaging stories that capture what your users want. GxP Genie guides you through the process, ensuring each story is user-centric and provides clear context, goals, and benefits.

Define Robust Acceptance Criteria:

Defining precise acceptance criteria ensures that your user stories are testable and meet user expectations. GxP Genie assists you in outlining conditions for success, helping your development team understand when a story is complete.


In the AI era, computer systems validation (CSV) must adapt to the complexities of artificial intelligence and machine learning technologies. Traditional methods of ensuring systems are correctly implemented and reliable now must address AI’s continuous learning, adaptability, and potential unpredictability. 

This involves rigorous validation processes, real-time monitoring, and advanced testing methodologies to capture AI behavior under various conditions, ensuring compliance with regulatory standards and ongoing performance.

The GxP Genie Platform goes beyond traditional validation and delivers insights into AI risk.



Implement enterprise-wide policies and programmatic controls to safeguard the usage of innovative AI systems in operational settings.


Perform AI risk assessment and mitigation for the entire AI lifecycle, including auditing and AI red teaming as-a-service.


Certify the validate AI solutions during testing, and production deployment.

Communicate regulatory compliance with internal and external stakeholders and capture feedback in a continuous manner.

Your Intelligent Validation Companion awaits!

No matter if you’re the System Owner, Business Leader, Validation Engineer, Quality Manager, or an IT Manager, GxP Genie can help you overcome validation challenges swiftly, effectively, and affordably.

Interested in learning more?