Alfresco

The USDM Life Sciences Alfresco VAP provides the components and services required to rapidly and cost-effectively meet FDA regulatory requirements associated with the validation of Alfresco / CARA:

  • Alfresco Validation Plan template defining the validation strategy and deliverables
  • Functional Requirement Specification (FRS) template tailored to life sciences application requirements
  • Risk Assessment template to address the basis for testing against the FRS requirements
  • Trace Matrix template to track the satisfaction of these requirements in the USDM Life Sciences Alfresco test protocols
  • Installation Qualification protocol template to document and verify your installed configuration of the application
  • Operational Qualification protocol template to document and verify the functionality of Alfresco
  • Performance Qualification protocol template to verify end-to-end business processes across Alfresco modules, representing the field service product lifecycle
  • Validation Final Report template to summarize the results of the validation effort
  • Standard Operating Procedure templates ready to tailor to your operations
  • Optional subscription to updated validation scripts for new Alfresco releases
  • Annual Supplier Audit reports of Alfresco by USDM, as required by FDA regulations and GAMP guidelines
  • Available automated testing tools for Alfresco to facilitate rapid re-validation of Alfresco for new releases
  • USDM Life Sciences consulting services to help design business processes in Alfresco and expedite the tailoring of the VAP templates to your configured Alfresco system, and facilitate test script execution
  • USDM Life Sciences consulting services to help design business processes in Alfresco and expedite the tailing of the VAP templates to your configured Alfresco system, and facilitate test script execution

 

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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