USDM, DocuSign partner to help life science companies manage regulated business process

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.