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

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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