Preparations and Considerations for Implementing a Validatable System

Evaluate vendors and internal processes that support
21 CFR Part 11 compliance

worksheet_cover_21_cfr_part_11_compliance

You’ve identified a need and use case for a 21 CFR Part 11 validatable system. This worksheet is designed to help walk you through the due diligence portion of the validation process to ensure that you properly evaluate vendors and internal processes before implementing a validatable system.

First Name *

Last Name *

Email *

Organization *

Primary Role *

Industry Segment *

How many studies does your organization manage? *

Is your organization's research centrally managed? * YesNo

Is your cancer center NCI-designated? * YesNo

Does your organization receive a CTSA? * YesNo

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Preparations and Considerations for Implementing a Validatable System

Evaluate vendors and internal processes that support 21 CFR Part 11 compliance

Evaluate vendors and internal processes that support
21 CFR Part 11 compliance