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.

USDM’s continuous compliance and validation solution delivers a proactive, always-audit-ready framework designed to keep life sciences organizations compliant in real time—without disrupting operations. Through its proprietary Cloud Assurance model and digital tools like ProcessX, USDM automates lifecycle validation, risk monitoring, and regulatory updates across cloud and on-premise systems. This approach eliminates the inefficiencies of traditional point-in-time validation by embedding compliance directly into daily operations, enabling seamless system upgrades and agile innovation. The result is a scalable, efficient, and future-ready compliance ecosystem that ensures consistent data integrity, reduces risk, and accelerates 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.

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Continuous Compliance & Validation
Continuous Compliance & Validation

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.

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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.

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Continuous Compliance & Validation
GxP best practices

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.

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Ensuring Data Integrity and Transparency

USDM Life Sciences ensures data integrity and transparency by delivering continuous compliance and lifecycle validation through a proactive, technology-first model that aligns with the unique needs of regulated life sciences environments. Their Managed Services model provides real-time monitoring, automated lifecycle validation, and robust data governance to maintain ongoing GxP compliance without interrupting daily operations. USDM’s proprietary frameworks like Cloud Assurance and digital quality tools such as ProcessX enable secure, scalable, and audit-ready systems that adapt to evolving regulatory demands. By integrating AI-driven analytics, automated testing, and advanced risk mitigation strategies, USDM not only ensures operational excellence but also empowers life sciences organizations to focus on innovation while staying confidently compliant at every stage.
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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

Automating compliance processes with cloud solutions is a transformative approach to achieving continuous compliance and validation in life sciences. By leveraging cloud-native platforms and tools like USDM’s Cloud Assurance, organizations can automate routine validation tasks, implement real-time monitoring, and ensure seamless system updates without compromising GxP compliance. These automated frameworks reduce manual effort, minimize human error, and provide built-in audit trails—making it easier to stay inspection-ready at all times. With continuous validation embedded into the system lifecycle, cloud solutions enable scalable, efficient, and proactive compliance management that supports innovation while maintaining regulatory confidence.

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%
1 %
Investigations into flagged issues were completed 50% faster
1 %
Avoided potential fines and delays from non-compliance saving an estimated $2M annually.
$ 1

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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