USDM Life Sciences Presents on Building Digital Trust Through Continuous GxP Cloud Compliance at Generate 2019

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World class content management, collaboration, and compliance in the cloud for the life sciences industry.

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It is critical to have a partner like USDM that bridges both the culture and technology gaps between regulation and agile software development as organizations move to the cloud

USDM Life Sciences and Generis have partnered to deliver a superior solution for enterprise content and information management with built in GxP compliance for the life sciences industry. USDM Cloud Assurance delivers a transformative, comprehensive solution to Generis customers to manage GxP validation and continuous compliance for Generis’ flagship product, CARA.

Presentation One:
What: Cloud Assurance and Digital Trust for Life Sciences in the CARA Cloud
When: Wednesday, March 13, 12:00 PM CET
Where: Generate 2019 — Hotel Palace — Berlin, Germany
Who: Kim Hutchings, Head of Alliances and Digital Transformation at USDM Life Sciences and
Holger Braemer, VP Europe Managing Director USDM Europe GmbH at USDM Life Sciences

As life science organizations move CARA to the cloud, learn how to best meet regulatory compliance requirements on ever-changing SaaS platforms. Furthermore, gain insights to building a roadmap to address digital trust in an increasingly agile environment. USDM is the leading expert on cloud compliance and taking life science organizations through digital transformation with thousands of projects implemented around the world.

“The life sciences industry has been trained to work in a standardized, controlled, and regulated way. Digital Transformation is not only necessary to succeed, it’s inevitable.” said Kim Hutchings, Head of Alliances and Digital Transformation at USDM Life Sciences. “It is critical to have a partner like USDM that bridges both the culture and technology gaps between regulation and agile software development as organizations move to the cloud.”

Kim Hutchings is the Head of Alliances and Digital Transformation at USDM Life Sciences. Kim has more than 15 years of experience in the life sciences industry and has managed USDM’s Alliances program for over a decade, establishing partnerships and solutions with best of breed technology vendors including Oracle, Generis, Salesforce, DocuSign, Loftware, and Box.

Holger Braemer is the VP Europe Managing Director at USDM Europe GmbH. Holger has more than 15 years in the life sciences industry and has worked for USDM partners like PTC, Dassault Systèmes-BIOVIA, Intel-Wind River, and Sparta Systems, with a strategic focus on the Pharma, Biotech, Medical Devices, and Healthcare industries.

Presentation Two:
What: Save Time and Money Through Smart Process Automation of Multi-Source Drug Safety Reporting at Bayer
When: Thursday, March 14, 12:00 PM CET
Where: Generate 2019 — Hotel Palace — Berlin, Germany
Who: Vikram Sharma, ECM Technical Lead at USDM Life Sciences

Adverse event reporting has traditionally been a manual, time consuming process that is prone to human error. With CARA and Documentum, Bayer’s reporting process is now fully automated. Bayer has reduced the workload of staff by 50% and eliminated human errors. USDM and Generis helped Bayer transform their adverse event handling, saving the multinational pharmaceutical company significant time and money.

Vikram Sharma is the ECM Technical Lead at USDM Life Sciences. Vikram has more than 18 years of software design and development experience with most of his career spent in the pharmaceutical industry.

Generate 2019 is March 12-14, 2019 in Berlin, Germany.

About USDM Life Sciences:

USDM Life Sciences provides strategy and compliant technology solutions to regulated life sciences companies and makes it easy to accelerate transformation and innovation. USDM Life Sciences focuses exclusively on the regulated biotechnology, pharmaceutical and medical device industries and is a compliance partner with the world’s top technology software developers. For more information, visit http://www.usdm.com

Ryan Carmel
USDM Life Sciences
(805) 865-2660
rcarmel(at)usdm.com

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Ryan Carmel
USDM Life Sciences
since: 10/2009
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