Salesforce

USDM-Cloud-AssuranceThe USDM Life Sciences Cloud Assurance Validation Accelerator provides the components required to meet FDA regulatory requirements including 21 CFR Part 11. 

The USDM Life Sciences Cloud Assurance (VAP) includes:

  • Force.com platform qualification
  • Salesforce Vendor Audit
  • Service Cloud VAP, including best practices for Chatter Compliance
  • VAPs for Salesforce Partners

The USDM Life Sciences Cloud Assurance (VAP) provides customers with:

  • SaaS Platform Qualification Plan defining the qualification strategy and deliverables
  • System Requirement Specification (SRS) customized to SF multi-tenant platform configuration and operations based on an in-depth USDM pre-qualification audit
  • Risk Assessment to address the basis for testing against the SRS requirements
  • Trace Matrix to track the satisfaction of these requirements in the executed USDM IT Test Protocols
  • Installation Qualification verifies the installed configurations and controls for:  
  • Data center facilities
  • Server/storage/network infrastructure
  • Software infrastructure
  • Database infrastructure
  • Operational Qualifications verifies the:  
  • Operational processes (security, management/monitoring, procedures, personnel, training)
  • System development and deployment processes
  • Updated documentation with Seasonal Updates (3 times a year) by salesforce.com to maintain compliance.
  • Updates available for annual Supplier Audits of salesforce.com by USDM, as required by FDA regulations and GAMP guidelines
  • Available VAPs and automated testing tools for select third party life science ISVs to facilitate rapid re-validation of SF platform update

With USDM’s Cloud Assurance, life science organizations can rest assured that the Salesforce platform is qualified and stays continuously compliant. USDM’s Cloud Assurance aligns with Salesforce releases and qualifies those releases before they are deployed. Once on a qualified platform, USDM can build and launch a variety of GxP workflows or applications. To learn more or schedule a demo, contact us at usdm@usdm.com

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Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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