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.
Ensuring Data Integrity and Transparency
Compliance Isn't About AI - It's About Process
This clip, from USDM’s 2026 Summit, we challenge a common misconception: simply labeling something “AI” doesn’t define its regulatory impact. What matters is intended use—and whether your processes uphold your compliance obligations.
If you’re navigating digital quality, automation, or AI-enabled innovation in a regulated environment, this conversation is essential. Watch the full summit on-demand to explore how forward-thinking leaders are aligning emerging technologies with continuous compliance, audit-readiness, and smarter operational outcomes.
The Importance of Computer System Validation (CSV)
Computer system validation (CSV) plays a critical role in ensuring data transparency and trustworthiness in regulated life sciences environments. By confirming that digital systems perform reliably and as intended, CSV safeguards the accuracy, consistency, and traceability of data throughout its lifecycle. This not only ensures compliance with global regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11, but also provides audit-ready assurance that data has not been altered, lost, or manipulated. Ultimately, robust validation practices enable life sciences organizations to make informed decisions based on clean, credible data—fostering transparency, minimizing risk, and supporting patient safety and product integrity.
Automating Compliance Processes with Cloud Solutions
Domain Expertise
Success Stories
A shift from periodic reviews to continuous monitoring delivered significant, measurable benefits for a clinical-stage pharmaceutical company. Learn more.
FAQs About Continuous Compliance & Validation
Unlike traditional, static validation that happens once and often becomes outdated, Continuous Compliance & Validation ensures systems remain always audit-ready by embedding compliance into everyday operations. USDM delivers a modern model powered by automation, cloud-native tools, and real-time monitoring—so compliance isn’t a project, it’s a program.
Regulatory expectations are evolving—and systems change rapidly. Continuous compliance helps life sciences organizations:
- Avoid compliance gaps from frequent software updates
- Reduce audit risks and inspection findings
- Enable faster go-lives with confidence
- Support digital transformation without sacrificing control
USDM makes this possible with ongoing oversight, system intelligence, and regulatory expertise.
USDM delivers:
- Lifecycle Validation Management for cloud, SaaS, and on-prem systems
- Automated compliance testing and documentation
- Audit trail and change control monitoring
- Cloud Assurance for platforms like AWS, Azure, Salesforce, Veeva, and ServiceNow
- ProcessX for automating and managing validation workflows
All supported by GxP-compliant frameworks tailored for regulated environments.
USDM delivers:
- Lifecycle Validation Management for cloud, SaaS, and on-prem systems
- Automated compliance testing and documentation
- Audit trail and change control monitoring
- Cloud Assurance for platforms like AWS, Azure, Salesforce, Veeva, and ServiceNow
- ProcessX for automating and managing validation workflows
All supported by GxP-compliant frameworks tailored for regulated environments.
We use:
- Pre-configured compliance accelerators
- Automated validation scripts and regression testing
- Reusable validation assets
- Smart scheduling to avoid redundant re-validation
This reduces manual effort and cuts validation timelines by up to 60%, without compromising regulatory rigor.
USDM ensures alignment with:
- FDA 21 CFR Part 11
- EMA Annex 11
- GAMP 5
- ISO 13485 / ISO 14971
- ICH Guidelines
Our solutions evolve alongside global regulations, ensuring you’re not just compliant today—but ready for tomorrow’s audits.
Cloud Assurance is USDM’s proprietary framework that enables:
- Ongoing validation of cloud updates and patches
- Automated testing, impact analysis, and change control
- Proactive compliance reporting and documentation
It transforms cloud system validation from reactive to real-time, scalable, and efficient.
Yes. Our frameworks are designed to support hybrid architectures, including:
- Cloud + on-premise systems
- Structured and unstructured data flows
- Integrated GxP and non-GxP systems
USDM ensures data integrity and process compliance across diverse, dynamic ecosystems.
USDM drives transformative outcomes such as:
- Reduced audit findings and regulatory risk
- Streamlined inspections and reporting
- Faster decision-making via trusted data
- Improved cross-functional data visibility
- Increased operational efficiency through automation.
Yes. Our GxP Managed Services provide continuous oversight of data systems, validation lifecycle management, and compliance monitoring. We maintain data integrity over time—not just at a point-in-time—with 24/7 monitoring, automated alerts, and performance dashboards.
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