Document Management Success: A Guide to Part 11 System Validation

Partnership Webinar

This webinar was produced in partnership with Complion, Regulatory and Document Management Platform for Clinical Research Sites. It will provide guidance for sites using internal tools (e.g. shared drives, USBs, CDs), a third-party eRegulatory and document systems, or other solutions (e.g. Box, Dropbox, SharePoint) to store electronic documents.

The session will cover what research sites need to know about validating computer systems, including:

  • What validation is and why it’s a critical part of Part 11 and GCP compliance
  • How to perform and document validation at your site
  • What is necessary to pass Sponsor, CRO and FDA audits
  • Critical questions you need to ask your IT team or vendor to quantify risks
  • Plus, get worksheets, templates, and SOPs to implement at your site

 

Co-presented by: Michelle Grienauer, JD, MPH, CIP

Michelle GrienauerMs. Grienauer provides guidance and consultation on legal and regulatory matters to Quorum Review and Kinetiq clients, drawing on her extensive knowledge of Food and Drug Administration (FDA) regulations, Office of Human Research Protection (OHRP) regulations, the Health Insurance Portability and Accountability Act (HIPAA), federally funded research, investigator-initiated research, and pediatric research. She is a member of the Washington State Bar Association, has a Master’s in Public Health (MPH), and is a Certified IRB Professional (CIP).

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Document Management Success: A Guide to Part 11 System Validation

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