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Session 10 Track 3: Maintaining Validation of Your Cloud Based Document Management Systems
Session Chair(s)
Karen McCarthy Schau
Director, Risk-based Study Management
Vertex Pharmaceuticals, United States
Companies must use an effective and agile strategy to manage new releases in order to maximize the value of a cloud-based document management system. The session will be an interactive audience participation regarding the identification of the major pain points associated with maintaining a cloud-based system in a validated state as new releases and features are provided by the vendor. The panelists are industry experts on Regulatory, Clinical and Quality Document Management System who will describe the best practices their companies use to assess the impact of the new release. Topics of discussions will include: analysis, planning, configuration, customization, and testing. A major aspect of the new release is the impact of the changes on business operations.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify the challenges in maintaining a cloud-based document management system in a validated state regarding new releases and features
- Define best practices for change control, validation, communication and training regarding new releases
- Determine unique aspects of maintaining Regulatory, Clinical and Quality Document Management Systems
Speaker(s)
Maintaining Validation of Your Cloud Based Document Management System
Michael Agard, MS, RPh
NNIT, United States
Director Clinical Consulting US
Maintaining Validation of Your Cloud Based Document Management Systems – eTMF from Business Perspective
Jamie Toth, MS
Beigene, United States
Global Head, TMF Management & Records
Managing Cloud Platforms Across Stakeholders - Platform vs Module Features
Jamie O'Keefe
Astrix, United States
Head, Clinical & Regulatory Consulting
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