Artificial Intelligence Regulatory Compliance
AI-Enabled Compliance for GxP Software
Simplify change management and accelerate development across your AI lifecycle.
For many teams, internal processes and tools are the main limiting factors to releasing AI-driven innovations faster. Implementing AI/ML in regulated environments requires pharma and biotech teams to overcome these challenges while maintaining compliance with GxP standards.
AI Regulatory Compliance
To use AI/ML in GxP environments, teams must scale innovation while staying compliant.
Advanced AI and ML models can enhance drug discovery, clinical trials, and manufacturing processes. But how do you integrate your AI/ML models into your existing validated systems and quality frameworks? Recent advancements in AI regulation provide opportunities for pharma companies to innovate responsibly.
Enable your data scientists to release frequently and use open-source AI/ML packages.
Scale your machine learning models to real-world demands.
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Use your preferred AI/ML tools
Accelerate AI compliance in software development and deployment while monitoring model drift and maintaining data integrity
Maintain control over AI/ML models and subsystems to ensure regulatory compliance
Download a free compliance template
Attract and retain data scientists and AI/ML engineers by allowing them to work in their preferred tools.
Connect model drift analysis and ML testing frameworks, leveraging them as evidence against GxP requirements.
Automatically create traceability between requirements in Jira and tests in Git (or another code repository).
Enforcement
Stay compliant with evolving AI regulations while accelerating innovation
Ensure AI/ML models remain compliant with FDA, EMA, and ICH GxP guidelines for AI in drug development, manufacturing, and clinical applications.
Explore enforcement
Built-in release gates ensure models have been validated before every deployment.
Transform data into specifications and leverage the specification approval process.
Built-in frameworks enforce best practices for coding, version control, and collaborative development.
Robust validation and verification processes ensure high quality.
Risk Management
Reduce the complexity of risk control and validation in AI-driven systems
Regulatory agencies require that any modifications to AI/ML models and subsystems undergo rigorous validation due to their potential impact on patient safety, efficacy, and product quality.
Learn more about risk controls in AI/ML
Enforce validation techniques to assess AI/ML model performance in regulated environments.
Ensure models perform well on new data through automated tests in your CI/CD pipeline.
Continuously monitor AI performance and risks in real-time to refine models based on new data.
Use a system of systems architecture to support ML-specific risk assessment
Traceability
Establish traceability for AI/ML workflows in GxP environments
Enable state-of-the-art AI solutions while all work is documented automatically.
Explore traceability
Automatically document your model development process as you build it.
Maintain traceability and visibility with an always up-to-date trace matrix.
Maintain a history of how raw data is pre-processed for model training and validation.
Connect to DataOps tooling to ensure traceability between model requirements and risks.
AI Governance
Innovate and scale faster without sacrificing quality though better AI governance
Built-in enforcement gives your AI Governance Committee or CoE transparency and control.
Watch AI/ML webinar
Release controls gate release until all approvers have signed.
Part 11-compliant signatures ensure approvals follow QMS procedures.
Maintain a full audit history history of how raw data is pre-processed for model training and validation.
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