Let USDM handle your GxP validation and maintain your cloud technology updates

USDM’s Cloud AssuranceTM is a managed service that offloads your cloud vendor management and maintenance of ongoing system updates, patches, and changes. USDM Cloud Assurance provides you with a harmonized, continuous-compliance experience across all your GxP cloud vendors.

With more than 200 life sciences companies subscribed to USDM’s Cloud Assurance platform, you can have confidence that we will implement best practices based on 20 years of life sciences compliance experience. We also provide validation acceleration tools and defensible evidence for FDA and global regulatory audits.

USDM Cloud Assurance is the compliant digital platform for cloud-based technologies of any size or complexity. Whether you have a single GxP cloud system or multi-cloud systems portfolio, Cloud Assurance will scale to meet your needs. Download our datasheet to learn how the benefits of Cloud Assurance increase with your company’s cloud adoption and organizational maturity.  
 

Cloud Assurance Benefits

  • USDM best practices, accelerators, and automation significantly decrease your implementation, validation, and maintenance effort to simplify your deployment and adoption
  • USDM expertise provides you with accelerated speed and scalability, better configurations, improved workflows, optimized use cases, organizational change management and training, expert program management, and better business outcomes to increase the ROI of your technology investments
  • Value realization for one system or all your systems
  • Delivered for Computer System Validation (CSV) or Computer Software Assurance (CSA)
  • Onboarding and initial validation include a defensible annual vendor audit for the FDA, Part 11 and EU Annex 11 Assessment, Validation Plan, URS/FSR, IQ/OQ/PQ Protocol and Test Scripts, Traceability Matrix, and Validation Summary Report
  • Ongoing Maintenance includes vendor release management, impact assessments, updated validation documents, test execution for core releases, analysis, and reporting
  • Rapidly growing partnership network and solutions to support secure and compliant multi-cloud and data-driven organizations
Now you see WHAT we can do; our partners are HOW we can do it with system expertise and GxP-ready capabilities. USDM’s world-class partners meet the quality and compliance demands of the life sciences industry. Together with Cloud Assurance, we have solutions for eSignature, clinical trial management, content and document management, QMS, LMS, RIMS, supply chain, and many more, to establish the foundation for your IT compliance.  
 

 

In Our Customer's Words

“We have worked with USDM on several implementation projects including Box GxP, ComplianceQuest and most recently DocuSign GxP. The USDM team consistently approaches projects pragmatically, with a high degree of professionalism and enthusiasm. I particularly appreciate that they do not take a ‘one size fits all approach’ and work collaboratively with all of our stakeholders to ensure our business objectives are met. Further, the USDM Cloud Assurance service offering is a key enabler for us being a lean life sciences organization. We look forward to our continued partnership with USDM.”
– Executive Director, IS

“Our company had to dramatically and immediately change the way we work while still ensuring patient safety and compliance during this global pandemic. Our validation of 21 CFR Part 11 DocuSign was completed in an amazingly short amount of time with a high degree of quality by working with the USDM Cloud Assurance team. USDM’s Validation Accelerator Package for DocuSign, coupled with USDM’s experience and knowledge of how the life sciences industry has configured the tool, created a successful implementation.”
- Duane Mixon, Director, IT Service Delivery

“In preparation for, and support of, our first commercial launch, we worked very closely with USDM across various validation and Veeva initiatives. As an anchor, USDM provided us with a right-sized and repeatable software validation methodology that we have successfully used to rapidly establish and maintain compliance [Cloud Assurance] across our 10+ multi-tenant, GxP platforms. Most notably, USDM seamlessly partnered with our company and Veeva to deliver numerous Vault initiatives (QualityDocs, RIM, PromoMats, eTMF, CTMS, eQMS).”
– VP of IT and Facilities

We will happily provide references on request.
 

One System or Many Systems

Shrinking IT budgets and growing business demands mean that you need a cost-effective, timesaving, managed service to achieve your business objectives. USDM Cloud Assurance combines cost savings and risk reduction to manage your technology and compliance process from end-to-end so you can focus on other priorities. We will take care of everything from hiring and managing the team, to building the processes and procedures or achieving consistency of your policies across the enterprise, to delivering results. Let us conduct an IS Health Check to assess your state of regulatory compliance and IS efficiency and provide a rapid, scalable plan to accelerate your IS maturity while handling your compliance workloads. 
 

Real Results

Read our case studies to see measurable results.
 

USDM Cloud Assurance is your comprehensive, one-stop-shop for IT compliance on a managed platform.

Contact us today to offload your compliance headaches.

Not sure if Cloud Assurance is the right solution for you? Here are some of the customers we have helped:

  • Medical device company needing product data integrated into a modern Quality Management System (QMS) to create more efficient workflows
  • Pharmaceutical company needing clinical collaboration in a GxP compliant environment
  • Start-up company with no IT resources from the life sciences industry who required Computer Systems Validation (CSV) expertise
  • Biotech company needing to upgrade to a faster document management system (or enterprise content management system) to streamline collaboration through workflows and eSignature approvals
  • Pre-commercial company, needing Digital Transformation Strategy and Roadmap to rationalize and consolidate applications, i.e., email, document management, file transfer protocol (FTP) servers and file share drives with a risk-based GxP compliance approach
  • Company planning or undergoing a change due to M&A activity and need guidance or helping hands to support your consolidation with standardization and harmonization

 
Read below for frequently asked questions or to search our many partners.

Cloud GxP Compliance Frequently Asked Questions

  • What is GxP?

    GxP is a blanket term that covers Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others. Each country has different regulatory requirements.
     

  • Should pharmaceutical companies store information in the cloud?

    Pharmaceutical companies are not just adopting native cloud-based technologies but starting to leverage these digital technologies for strategic advantage. The efficiency derived is more than just financial. Cloud solutions provide greater elasticity, scalability, security, and performance as compared to on-premise systems. Further, the cloud is driving entirely new business models to enable rapid growth and global collaboration while maintaining quality and compliance standards. The journey to the cloud is a necessity to survive in today's hyper-competitive business landscape.
     

  • How is it less expensive to manage continuous compliance externally?

    Our Cloud Assurance program is more cost-effective than managing internally because we spread the cost to maintain compliance across our customer base, which reduces every customer cost from both an IT and a Quality perspective. Customers don’t have to hire full-time resources, which often required 2-3 people depending on how many systems you have. And the peace-of-mind in not having to worry about compliance creates significant benefits too.

  • Should medical device companies move to the cloud?

    Digital technologies like cloud storage and cloud computing are becoming a necessity to grow your medical device business. Cloud solutions not only decrease cost, but they drive greater collaboration and connectivity, greater efficiency, allow for enterprise-grade security, workforce mobility, improved culture, and ultimately future growth and innovation.

  • Why can’t my company rely on my vendor's testing process?

    With 100+ cloud migrations executed, our experience has been that customers need a proper vendor audit to demonstrate that the testing and quality systems meet the basic FDA requirements. Vendor testing of their system is typically not sufficient in providing this required evidence, and many customers have had to get a 3rd party to conduct this audit, anyway, further delaying their progress by not doing it upfront. And beyond the initial testing, there is the ongoing regression testing for new software releases.  USDM is experienced in automated regression testing based on the customer's instance and GxP needs. Cloud Assurance has been successfully audited by the FDA and has a proven methodology for conducting these vendor audits.

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