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Agile Computing Authors: David Dodd, Anders Wallgren, Dana Gardner, Pat Romanski, Philippe Abdoulaye

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USDM Partners with DocuSign to Help Life Sciences Organizations Go Fully Digital

DocuSign, Inc. (DocuSign®) and USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, today announced a new partnership to help organizations automate regulated business processes for dramatic ROI, increased security and compliance, and faster speed to market. DocuSign offers the industry’s only 21 CFR Part 11 compliant Digital Transaction Management (DTM) platform for easily, safely and securely managing transactions in the cloud, including clinical trials, electronic batch records, regulatory filings, training, change control, field service reports, recall notifications, laboratory procedures and more.

“USDM is pleased to have partnered with DocuSign as the global standard for Digital Transaction Management to expand our Validation Accelerator Pack (VAP) and Cloud Assurance solution,” says Kim Hutchings, Vice President of Alliances at USDM Life Sciences. “Our joint solution brings together USDM’s 10 plus years of VAP experience in the cloud with the power of DocuSign’s DM platform so our customers have an easy to implement, easy to validate solution that accelerates speed to market while meeting critical 21 CFR Part 11 requirements.”

With DocuSign, life science companies can easily, safely and securely manage regulated business processes including clinical trials, electronic batch records, regulatory filings, training, change control, field service reports, recall notifications, and laboratory procedures.

“Our partnership with USDM gives life sciences organizations further confidence to go fully digital with DocuSign as the catalyst for their digital transformation,” said Neil Hudspith, chief revenue officer, DocuSign. “Now life sciences companies can manage all aspects of GxP regulated business processes in the cloud with DocuSign to eliminate paper to accelerate approval times, reduce errors and cut costs to bring critical research and treatments to market faster.”

DocuSign delivers transaction security and compliance for organizations of all sizes, in a wide-ranging number of use cases, with an end-to-end digital solution that is changing the way life sciences companies do business. USDM’s integrated solution with DocuSign 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 DocuSign VAP contains validation plans, system requirements, IQ/OQ/PQ test scripts, a traceability matrix, and a vendor audit report. The USDM Cloud Assurance offering provides updates to this VAP content with each DocuSign release, and can be executed by USDM to save time and testing costs.

USDM and DocuSign will host a complimentary webinar on Thursday, July 17, titled “The Silver Lining in the Cloud: eSignatures and Digital Transaction Management” to further discuss the DocuSign VAP, including DocuSign’s Part 11 capabilities, and best practices for life science companies seeking to digitize business processes. Individuals may click here to register.

To learn more about USDM please visit or call (888) 231-0816 or via email at [email protected]. Companies interested in learning more about DocuSign may visit or contact DocuSign sales at +1 (877) 720-2040 or via email [email protected].

About DocuSign, Inc.

DocuSign® is The Global Standard for Digital Transaction Management™. Global enterprises, business departments, individual professionals, and consumers have standardized on DocuSign, with more than 40,000 new users joining the DocuSign Global Network every day. Today, that network includes millions of users in 188 countries. DocuSign's DTM platform supports legally compliant electronic and digital signature processes tailored to meet requirements globally with localization in 43 languages. Companies and individuals DocuSign to accelerate transaction times to increase speed to results, reduce costs, increase security and compliance, and delight customers across nearly every industry – from financial services, insurance, technology, healthcare, manufacturing, communications, real estate, retail, and consumer goods to higher education, non-profit and others – as well as every business department, including sales, finance, operations, procurement, HR/staffing, legal, and customer support. DocuSign offers transaction management services and is the NATIONAL ASSOCIATION OF REALTORS® Official and Exclusive provider of electronic signature services under the REALTOR Benefits® Program. For more information, visit or call 877.720.2040. Visit the DocuSign blog at and follow DocuSign on Twitter, LinkedIn, and Facebook.

About USDM Life Sciences:

USDM Life Sciences is a leading global regulatory consulting firm providing compliance, business intelligence, validation, qualification, quality auditing and IT services via project teams and staff augmentation to our clients in the Medical Device, Biotechnology, Biologics, Diagnostics and Pharmaceutical industries. USDM has more than 14 years of experience supplying our clients in the life science industry with compliance services during each phase of their drug and product development cycle while partnering with best of breed organizations to help companies simplify, unify and optimize their business and compliance objectives.

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