USDM’s Cloud Assurance is a managed subscription service delivering end-to-end GxP cloud compliance from implementation through ongoing validation maintenance of new releases.


Need continuous cloud compliance for your life science company?
 
If you are a:

  • 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
Consider our end-to-end GxP cloud compliance service, Cloud Assurance.
 
Cloud Assurance provides customers a harmonized, continuous compliance experience across all their cloud vendors. With 20+ years of experience and thousands of GxP projects delivered, USDM’s team of regulatory and technology experts bridge the gap between quality compliance standardization and IT agile innovation.

Contact USDM to Talk About Continuous GxP Cloud Compliance

Validating GxP Systems with Cloud Assurance

Cloud Assurance is the leading digital assurance solution for life science companies.

  • Quality auditors ensure your systems are continuously GxP compliant and ready for FDA audits, EU audits, or your local regulatory agency
  • Cloud compliance methodology and toolkit successfully audited by regulatory agencies
  • Reduce implementation and validation time
  • Harmonize and centralize control of GxP cloud compliance
  • Decrease the cost to manage cloud compliance 
  • Management of new releases for continuous cloud compliance
  • Scalable vendor solutions to grow with your business and establish your compliant IT foundation

 USDM’s Cloud Assurance is THE solution for continuous GxP cloud compliance

How does USDM ensure continuous compliance?
There are three distinct phases to Cloud Assurance: Vendor Audit, Implementation and Validation, and Continuous Compliance.

Vendor Audit
When a life science company, such as a medical device manufacturer or pharmaceutical company, works with us to ensure that they are GxP compliant, we start by auditing their current processes, technology, and manufacturing. We have a quality team of auditors that have conducted thousands of audits for companies internationally and apply a though approach and targeted, leaner approach in subsequent years.

Implementation & Validation
After we’ve audited your organization’s practices, we’ll come to you with a plan for implementing the GxP compliant changes, validate them, and accelerate your company’s digital assurance.

We’ll do things like: 

  • Part 11 and Annex 11 Assessment
  • Create a validation plan
  • Draft user requirements and functional specifications
  • Risk and impact assessment
  • Develop IQ/OQ/PQ protocols and test scripts
  • Create, test, and train you on a traceability matrix
  • Develop user and administration SOPs
  • Deliver a validation summary report

Learn how USDM implemented Box GxP in less than 30 days for a pre-commercial oncology research company to accelerate their compliance readiness.

Continuous GxP Compliance
After our initial setup, audit, implementation, and validation, we’ll continue to work with you and your processes to ensure full GxP compliance. We’ll manage new vendor releases, conduct impact assessments from release notes, update validation documents, run automated regression tests, and provide the analysis and reporting.

Our process helps many companies, just like yours, to be more efficient, save resources, and accelerate the growth of their company and products. Our GxP validation services and continuous compliance management will help your company stay compliant since we keep abreast of the global regulatory requirements, continually looking to the future, e.g., validation of cloud-based solutions that leverage artificial intelligence so you can drive innovation. Learn how USDM built out custom validation applications using Salesforce GxP capabilities for a large medical device manufacturer with fragmented workflows and enabled 75% faster, more accurate approvals while decreasing IT licensing costs by $750k annually.

Download the Cloud Assurance overview to learn more:



 

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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