DocuSign Launches Winter '16 Release with Focus on Life Sciences
Improved Features to Support Compliance with 21 CFR Part 11 Tops Enhancements, Along with Print, Search and Credit-Risk Management
Improved Features to Support Compliance with 21 CFR Part 11 Tops Enhancements, Along with Print, Search and Credit-Risk Management
SAN FRANCISCO, Dec. 10, 2015 /PRNewswire/ -- As part of its commitment to help organizations around the world transform processes to make every approval, decision, contract and workflow 100% digital, DocuSign Inc. (DocuSign®) today released enhancements to its Digital Transaction Management (DTM) platform and eSignature solution.
The DocuSign Winter '16 Release includes several enhancements and updates, one of which aims to help life sciences companies – pharmaceutical and medical device manufacturers and clinical research organizations – more easily comply with stringent regulations like Title 21 CFR Part 11.
'Part 11', as it's often known, covers US Food and Drug Administration (FDA) regulations on electronic records and electronic signatures – defining how and when these electronic documents are considered trustworthy, reliable, and equivalent to paper records.
"We've seen life sciences firms take great strides in evolving their connectivity and collaboration strategies – two of the key elements of digital transformation," explains Matt Malden, chief product officer, DocuSign.
"Where they can often fall short is one of the other key elements – compliance – especially where Part 11 is concerned. Organizations must implement comprehensive controls for software and systems involved in processing any electronic data they are required to retain, but often find it to be a massive undertaking."
The DocuSign Winter '16 Release helps alleviate the hurdles of going fully digital in life sciences by enhancing the company's REST and SOAP Application Programming Interfaces (APIs) in the 'Part 11 Module'. Product enhancements also improve the user experience when sending and signing Part 11 regulated documents – all of which make it easier and faster for companies to integrate Part 11 workflows into their clinical and quality systems.
Several companies have been working closely with DocuSign on the enhanced Part 11 Module – and seeing even greater digital adoption as a result.
"DocuSign has been a great partner in expediting our digital journey," said Bob Mullins, senior director of information technology, ACIST Medical Systems.
"The integration with our in-house app used by representatives in the field, the help of DocuSign's customer success architects to deploy the product, and the due diligence in developing a platform to meet Part 11 specifications have all allowed us to easily send, sign and manage our documents in the cloud – while ensuring that we keep our business compliant with FDA regulations."
In addition to the Part 11 functionality, DocuSign users around the world will benefit from other enhancements in the company's latest release, including:
For more information on the DocuSign Winter'16 Release, visit https://www.docusign.com/blog/the-docusign-winter-16-release-is-here, and for more information on the company's life science solutions, visit https://www.docusign.com/solutions/industries/life-sciences.
Contact:
Gregor Perotto
DocuSign, Inc.
(206) 576-8081
[email protected]
About DocuSign, Inc.
DocuSign® is changing how business gets done by empowering more than 100,000 companies and more than 50 million users in 188 countries to sign, send and manage documents anytime, anywhere, on any device with trust and confidence. DocuSign replaces printing, faxing, scanning and overnighting documents with the easiest, fastest, most trusted way to make every approval and decision digital. Organizations of all sizes, industries and geographies are accelerating contracts, approvals and workflows with DocuSign's eSignature software and Digital Transaction Management (DTM) platform. DocuSign keeps life and business moving forward.
For more information, visit http://www.docusign.com, call +1-877-720-2040, or follow us on Twitter, LinkedIn and Facebook.
Copyright 2003-2015. DocuSign, Inc. is the owner of DOCUSIGN® and all of its other marks (www.docusign.com/IP). All other marks appearing herein are the property of their respective owners.
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SOURCE DocuSign, Inc.
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