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Alfresco

Alfresco and USDM Life Sciences have partnered to provide an end-to end program for new and legacy CFR 21 Part11 compliant ECM requirements involving a combination of Alfresco’s product and USDM’s industry consulting services.

With USDM Cloud Assurance for Alfresco, life science customers can now use Alfresco to manage all aspects of GxP regulated business processes to:

  • Provide “preconfigured product modules” across the GxP enterprise. Examples are quality, clinical, R&D, and regulatory business modules
  • Competitive cloud based subscription based pricing
  • Lower significantly the overall cost of ownership
  • Eliminate paper, accelerate approval times and improve compliance
  • Ease burden and increase collaboration with partner and affiliated companies

Alfresco and USDM Life Sciences have partnered to enable life science companies to streamline their regulated content process and allow for a rapid implementation of the CARA solution. USDM has expanded its VAP and Cloud Assurance offering to include a Validation Accelerator Pack and compliance offering for Alfresco / CARA that enables Alfresco customers to meet 21 CFR Part 11 and can be easily implemented and validated.

Alfresco customers can now manage regulated business processes including clinical trials, electronic batch records, regulatory filings, training, change control, field service reports, recall notifications, and laboratory procedures.

USDM’s Validation Accelerator Pack (VAP) and Cloud Assurance offering for Alfresco enables life science customers to achieve and maintain compliance in the cloud. USDM’s Cloud Assurance offering for Alfresco is based on more than a decade of VAP development and created by leaders in the life sciences cloud.

The USDM Cloud Assurance offering for Alfresco includes:

  • Validation Accelerator Pack (VAP) / Qualification Package
  • Vendor Audit (updated annually)
  • Validation Maintenance Package (updated as changes are made with new releases)
  • Test automation options
  • Subscription based services, providing the ability to maintain compliance

The Alfresco VAP contains validation plans, system requirements, IQ/OQ/PQ test scripts, a traceability matrix, and a vendor audit report. The Cloud Assurance offering provides updates to this VAP content with each software release, and can be executed by USDM to save time and testing costs.

With USDM Cloud Assurance for Alfresco, life science customers can now use Alfresco to manage all aspects of GxP regulated business processes to:

  • Eliminate paper, accelerate approval times and reduce errors
  • Enable an end-to-end digital solution throughout the GxP spectrum
  • Reduce costs
  • Streamline processes
  • Increase collaboration

Alfresco and USDM Life Sciences are changing the way life sciences organizations do business by allowing critical research and treatments to go to market faster and improving compliance throughout the process.

 

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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