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Qualifying a Software Vendor in a Regulated Industry

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 19, 9:00AM - 10:00AM (Pacific Standard Time)

Session Number:
405

Room Number:
10

Level:
Basic

Type:
Session

Title:
Qualifying a Software Vendor in a Regulated Industry

Chair(s):
Mark Willis, MS, PMP
Owner Lead Consultant
Willis QS Consulting, United States

Description:
As technology continues to advance, so must the techniques surrounding the qualification of a software vendor for use in a regulated industry. This session describes the audit process, the financial aspect, and the evaluation of the associated risk.

Learning Objective(s):
Discuss what it exactly means to qualify a software vendor and why it is important to an organization; Translate knowledge of competencies required to perform an audit of a software vendor in a regulated industry; Define the financial structure of maintaining an organization that performs software audits and vendor qualifications.

Presentation(s) & Speaker(s):
Regulatory Requirements for Qualifying a Software Vendor
Mark Willis, MS, PMP
Owner Lead Consultant
Willis QS Consulting, United States