How Life Sciences Companies Can Use Electronic Records and eSignatures in the Cloud

 The Life Sciences industry is evolving into a more distributed, collaborative and specialized ecosystem where collaboration happens across multiple specialized organizations in order to manufacture, package, perform trials and perform lab work. Information is difficult to exchange electronically especially due to 21 CFR Part 11 concerns about electronic records and electronic signatures.  In addition, the industry is moving many software systems into the Cloud adding to the complexity of relying on electronic records and electronic signatures.

Join this webinar to learn about DocuSign’s Digital Transaction Management solution, which is designed to be 21 CFR Part 11 compliant with the help of USDM Life Sciences.

The discussion will include:

  • A case study on implementing DocuSign’s Digital Transaction Management solution in the life sciences industry
  • A discussion of the Part 11 capabilities of the system
  • A discussion on how rapidly this solution can be deployed to alleviate current business / compliance bottlenecks
  • Live Q & A session

Speakers:

Kevin Foley, Former FDA Auditor, Senior GMP Auditor at USDM Life Sciences
Kevin Foley is a Senior Auditor for USDM Life Sciences. He brings more than 10 years of experience from the FDA. At the FDA, Kevin was a consumer safety officer, quality systems trainer and manager, foreign drug cadre investigator and biologist/analyst.

Matt Pelham, Principal Enterprise Solutions Engineer at DocuSign
Matt Pelham has been with DocuSign for over 4 years and serves as a principal Enterprise Solution Engineer. In his role he has worked with many Fortune 500 and Global 2000 clients to architect solutions leveraging the DocuSign platform to help clients eliminate paper based processes, increase compliance, decrease cycle times, reduce costs, and enhance customer satisfaction.

Subbu Viswanathan, Vice President IT/Virtualization at USDM Life Sciences
Subbu Viswanathan is the Vice President of IT/Virtualization and Life Sciences Cloud at USDM Life Sciences. He has more than 16 years of technology, software development, infrastructure, virtualization, validation, and compliance experience focused on the life sciences industry.

 

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