Trust and Compliance

Continuous Compliance & Validation

Streamline release management, reduce costs, and discover a single source of truth for compliance.

Automated testing for GxP applications empowers your organization to maintain audit readiness, lower IT costs, and accelerate time to market.

Stay Continuously Compliant and Audit-Ready with USDM's Automated Cloud Assurance

Automate compliance updates and monitor regulatory changes to help your systems meet FDA, EMA, and other global standards. Our Cloud Assurance subscription offers continuous compliance and validation for cloud-based applications, including platforms like Box, Veeva, and Microsoft. This proactive approach reduces downtime, enables seamless upgrades, keeps systems compliant, and enhances operational efficiency.

Achieve Peace of Mind with Cloud Assurance Certified Vendors

Demonstrate regulatory readiness and audit resilience. Our Cloud Assurance Certified program recognizes technology vendors that meet the quality and compliance demands of the life sciences industry. It is THE badge of trust for GxP functionality. Cloud Assurance Certified technologies undergo a rigorous compliance, security, and data integrity assessment by our team of experts to verify compliance with thousands of global health authority statutory and regulatory requirements.

Streamline Validation Lifecycle Management with ProcessX

Simplify and automate validation processes across the entire lifecycle of regulated systems. ProcessX Validation Lifecycle Management (VLM) from USDM combines automated validation, real-time monitoring, and compliance reporting to help you meet regulatory requirements with greater efficiency. ProcessX VLM helps streamline compliance, reduce manual effort, and maintain a complete audit trail for validated processes.

Boost Compliance Efficiency and Focus on What Matters Most with CSA

Use a risk-based approach for software validation to ensure that critical areas are thoroughly tested, prevent unnecessary documentation, and move away from old-school validation efforts. With a focus on the FDA’s CSA guidelines, we help you increase validation efficiency and speed up time-to-market by automating testing for non-critical systems and directing resources to high-risk areas. This service enhances compliance and productivity by aligning validation efforts with system risk.

Domain Expertise

Success Stories

A shift from periodic reviews to continuous monitoring delivered significant, measurable benefits for a clinical-stage pharmaceutical company. Learn more.

Manual audit trail review reduced by 80%

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Investigations into flagged issues were completed 50% faster

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Avoided potential fines and delays from non-compliance saving an estimated $2M annually.

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