Make quality reliable and smart
Regulatory compliance is essential for quality-focused organizations, yet disconnected systems, manual workflows, and lack of standardization often pose significant challenges.
Harness the power of automation, integration, and AI-driven insights to increase QC lab productivity by up to 40%. Ensure compliance, avoid deviations, reduce inspection times, and enable real-time-release.
Safeguard data integrity
Keep scientific data safe, secure, and accurate by upholding ALCOA++ throughout the data lifecycle
Rely on high-fidelity, traceable data to ensure regulatory compliance and drug product quality and safety
Adhere to industry regulations and guidelines, including 21 CFR Part 11, GxP, and Annex 11
Lay the foundation for quality
Reduce transcription errors by 75% by moving from manual data handling to automated data collection and preparation
Drive consistency and repeatability across operations with a single source of truth and standardized, normalized data
Ensure drug and patient safety with contextualized, compliant data that can easily be shared across divisions
Streamline compliance efforts
Expedite or eliminate manual data reviews and second-scientist verification through automation and full traceability
Streamline data aggregation and documentation for CoAs, dossiers, regulatory filings, and audit preparation
Minimize validation efforts by 80% with our GxP documentation package and our compliant solution
