DIA 48th Annual Meeting
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Innovative Ways of Looking at Computer System Validation
Track : Track 07: Processes and Technologies for Clinical Research
Program Code: 249
Date: Tuesday, June 26, 2012
Time: 1:30 PM to 3:00 PM  EST
Ron Fitzmartin, FDA
 Uwe Trinks, Foresight Group International AG, United States
Eric Staib, Covance, Inc., United States
 Keith Parent, Court Square Group Inc., United States
Much has been proselytized on computer systems validation (CSV) for years. However, as the pharmaceutical industry has changed, and is still changing, so the established dogma of CSV, with its associated mysticism and time-consuming and costly practices is still proving stubbornly resistant to modernization. This interactive panel session will discuss the key issues, address the hurdles to change, and present a set of clear recommendations.

Learning Objectives:
Discuss the major computer system validation challenges for software/ system vendors
Evaluate the current computer system validation issues related to GCP, GMP, GLP
Summarize the meaning of of true risk-based computer system validation Enumerate recommended solutions for more efficient and effective computer system validation.