USDM enables pharmaceutical, biotechnology, and medical device companies to transform their GxP workflows with Cloud Assurance for Azure. The solution addresses SaaS (business applications), PaaS (cloud services), and IaaS (global infrastructure). All packaged in USDM’s Cloud Assurance subscription to manage ongoing updates and decrease your compliance burdens.

FEATURES

Cloud Assurance provides expert compliance services, fast-start accelerators, and defensible validation deliverables based on 20+ years of life sciences solution delivery.

• Expert Compliance Services – an Annual Vendor Audit, Infrastructure Qualification, Cloud Services Qualification, Cloud Application Validation, and an IS Health Check

• Fast-Start Accelerators – Impact Assessments, Procedures & Controls, Change Management, and Qualification Package

• Defensible Validation Deliverables – Qualification(s), Qualification Plan (System Requirements, Configuration Specification, CQ/PQ, Qualification Report), USDM’s Assurance Report and Vendor Certification

BENEFITS

By leveraging USDM’s life sciences expertise and accelerated cloud services, you can rapidly implement a GxP compliant framework.

• Reduce your compliance risk and achieve continuous cloud compliance with USDM’s framework and accelerators for Azure

• Speed deployment and adoption of Azure and Microsoft business applications with prepackaged solutions built-on life sciences best practices
• Accelerate your cloud journey by identifying strategic business initiatives made possible with Azure

• Flexible cloud adoption model to migrate regulated workloads

• Cost-effective, bundled solution to minimize barriers to compliance and innovation

• Build value-creating activities, decrease value-consuming activities