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Computer System Validation in the Cloud: Cloud Is Here Today and Here to Stay

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
264

Room Number:
31C

Level:
Intermediate

Type:
Session

Title:
Computer System Validation in the Cloud: Cloud Is Here Today and Here to Stay

Chair(s):
Frances E. Nolan, MBA
Vice President, Quality and Regulatory Affairs
Medidata Solutions Worldwide, United States

Description:
Organizations developing and using computerized systems are benefiting from novel approaches to the development, validation, and deployment of such systems in a regulated environment. This session will provide real examples of how practices such as Agile software development, Software/Platform/Infrastructure as a Service, and cloud deployment are being used today to great effect. The session will also address what these practices mean to suppliers, sponsors and CROs, and regulators.

Learning Objective(s):
Discuss how suppliers can leverage novel practices in their own development and deployment of systems, including making their computer system validation deliverables more accessible by their customers; Identify how sponsors and CROs can optimize their user acceptance testing (UAT) by leveraging supplier practices; Describe how regulators can consider changes in their inspection approach in order to assess the adoption of these novel practices.

Presentation(s) & Speaker(s):
Computerized System Validation in the Cloud
Frances E. Nolan, MBA
Vice President, Quality and Regulatory Affairs
Medidata Solutions Worldwide, United States

CSV in the 21st Century: A Customer Perspective
Mark Connolly, MSc
Head of IT Applications
ICON, Ireland

CSV in the Cloud: Regulatory Perspective
Ron Fitzmartin, PhD, MBA
Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
FDA, United States