Risk-based validation, AI-generated tests, automated execution, and end-to-end traceability — kept continuously current on a living digital ledger, so every GxP system is audit-ready at any moment.
Leverage our extensive library of industry-validated documents for MedTech and Pharma to fast-track your journey to strategic excellence. Automate time-consuming validation tasks, freeing you to focus on innovation and strategy. Speed up documentation cycles with effortless iteration—no need to start from scratch.
Enhance quality and compliance with instant, AI-powered feedback on your validation documentation. Seamlessly integrate into Agile workflows, ensuring documentation evolves with your development process.
Choose from extensive library of pre-defined agentic workflows including risk evaluation and test case generation.
Built for effortless navigation, GxP Genie’s intuitive interface makes validation easy for users of all experience levels. Streamline your work with easy-to-follow workflows that align with industry standards and project needs.
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 demo today to witness how GxP Genie will transform your validation processes and revolutionize your industry.
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.
Drop in your user story acceptance criteria — the agent reads them and extracts the test steps. Each is linked to its source requirement and risk level.
Your scenario becomes a ready-to-run Playwright test in seconds. Requirement and risk are embedded in the script itself.
The test runs automatically against your app, just like a real user. Every result, timing, and step is captured per run.
Screenshots, video, and logs are collected on every run. Timestamped and sealed as tamper-proof evidence.
One record links requirement, risk, script, result, and evidence. Feeds straight into your traceability matrix.
A reviewer approves or rejects with an electronic signature. Independent review triggers for higher-risk tests.
Agents assist, suggest, and adapt so your teams stay in control with explainable AI.
GxP by design. Aligned with ALCOA principles, GAMP 5, and FDA CSA Guidance.
Full traceability, signature verifaction, audit trailed and 21 CFR Part 11 compliant.
WHITEPAPER
With industry and regulators advocating for modernization through critical thinking,
risk-based processes, and automation, now is the time to evolve.
