21 CFR Part 11: Vendor vs. Sponsor Responsibilities
Presented by Shannon Roznoski
Many clinical researchers are making the switch to software solutions that electronically capture data for their clinical trials. In order to submit this captured data to the FDA, sponsors must use a 21 CFR Part 11 validated system; however, the responsibilities of sponsors versus vendors during this process may be unclear to those new to validation.
Join us for this webinar, as Shannon Roznoski, Product Manager at Forte Research Systems, walks through an overview of 21 CFR Part 11 and the roles both vendor and sponsor play during the validation process of an EDC system.
You’ll learn how to:
- Distinguish when the regulation applies to validation activities
- Determine processes and controls sponsors should establish prior to EDC system implementation
- Identify controls and procedures EDC vendors should have in their systems
Previously recorded: March, 2016
Duration: 60 minutes
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