Compliance Simplified

Cloud Assurance Certified

USDM Life Sciences is the most trusted company in the pharma, biotech, and medical device industries for compliant technology solutions. Enabled by USDM Cloud Assurance we are strengthening this trust with our new Cloud Assurance Certified program.

What is Cloud Assurance Certified?

More than 300 life sciences customers entrust their compliance implementation and maintenance to USDM, and our Cloud Assurance managed service subscription has become the industry standard for continuous compliance in the cloud. Cloud Assurance Certified recognizes technology vendors that meet the quality and compliance demands of the life sciences industry and is THE badge of trust for GxP functionality. Together, they signify your commitment to enrich pharma, biotech, and medical device companies and make compliance a competitive advantage.

Cloud Assurance Certified technologies must undergo a rigorous compliance, security, and data integrity assessment by USDM Life Sciences and demonstrate their compliance with the consolidated global health authority statutory and regulatory requirements.

Read our blog – Cloud Assurance Certified: What Does It Mean? – to learn more.

Cloud Assurance Certified Technologies

How does Cloud Assurance Certified work?

 

USDM conducts an extensive assessment of vendor technology using our proprietary Unified Compliance Matrix to ensure credibility and compliance to global regulations.

USDM shares the assessment with the vendor and works with them to remediate all GxP gaps in their technology.

Once all gaps are remediated, continuous compliance is established, and the technology passes the assessment, USDM publishes a third-party Vendor Assurance Report that customers can leverage as regulatory evidence. It minimizes their internal validation effort and saves them time and money while reducing risk.

USDM also performs the initial qualification or validation and creates the automated test scripts using the U.S. Food and Drug Administration (FDA)-approved Computer Software Assurance (CSA) methodology.

When a vendor’s technology is certified, customers can trust that they meet or exceed the global regulatory requirements for their business. USDM deliverables include:

  • USDM Vendor Audit (conducted annually)
  • USDM Vendor Assurance Report (completed annually)
  • USDM’s Cloud Assurance continuous compliance subscription to minimize validation and compliance burdens (includes the initial qualification or validation and ongoing release management)

Interested in becoming Cloud Assurance Certified?

Related Services

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Artificial Intelligence

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