Document Management Success: A Guide to Part 11 System Validation
Does your site keep electronic documents using internal tools (e.g. shared drives, USBs, CDs), a third-party eRegulatory and document system, or in another solution (e.g. Box, Dropbox, SharePoint)?
Did you know that in addition to the FDA’s 21 CFR Part 11 regulation, the November 2016 revisions to ICH GCP E6 (R2) also require sites to validate those systems? Further, that validation needs to happen before using that system and prior to any changes being made by your IT team and/or vendor?
Join us for an educational presentation to learn what clinical research sites should know about validating computer systems. We’ll dispel several myths and misunderstandings including when regulations apply, what is validation, how to perform validation, how to identify potential risks, and handle FDA / Sponsor / CRO audits.
Learn 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
- Understand what is necessary to pass Sponsor, CRO, and FDA audits
- Critical questions you need to ask your IT team or a vendor to quantify risks
- How to handle a sponsor, CRO, or FDA Part 11 audit
- Receive a free Validation Worksheet
Access the webinar now!
Senior Regulatory Attorney, Kinetiq
Michelle Grienauer is a Senior Regulatory Attorney for Kinetiq, a consulting and technology division of Quorum Review IRB. Michelle provides guidance and consultation on legal and regulatory matters, 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.
Michelle previously worked as a regulatory analyst and IRB member for Seattle Children’s Research Institute and as Assistant Director of the VA Puget Sound Health Care System Human Research Protection Program.
Michelle received her Juris Doctor with honors from University of Washington in 2010 and was admitted to the Washington State Bar Association (WSBA) in the fall of 2010. She also earned a Master’s in Public Health from Boston University in 2007. She is a member of the WSBA Health Law section, Washington State Society of Healthcare Attorneys, and Northwest Association for Biomedical Research.
Having monitored more than 300 clinical trials, Cristina is a certified clinical research professional with an impressive array of experience in both industry and academic settings. She obtained a MPH from Case Western Reserve University, has led hundreds of educational presentations both locally and nationally, and has been awarded first honors by several professional research organizations for her work in research compliance and oversight.
Cristina’s career began in 1997 at Case Western Reserve University as a Research Assistant for the Genetics Department, then moved to the Epidemiology and Biostatistics department where she oversaw the regulatory affairs including the development of submission materials and securing approvals from IRBs, participant recruitment, and research compliance oversight.
In 2003, Cristina joined the R&D department of a leading skin care organization as a Scientist, where she designed field studies to understand the impact of infections and infectious diseases. She served as the Primary Investigator from budget development and protocol design through execution to completion, and statistical analysis which resulted in several presentations and a publication in the Journal of Military Medicine.
In 2005, Cristina joined University Hospitals Cleveland Medical Center. Initially, as a Research Compliance Specialist, she helped develop a health-system wide research education and monitoring/auditing program. The success of this program lead to awards and acknowledgements of multiple posters and publications with several International Research Organizations. Then she transitioned to the role of Manger of Community-Based Clinical Research. In this role, she facilitated the conception and development of community-based clinical research satellite units based throughout the University Hospitals System entities. Cristina was responsible for establishing operations, including policies and procedures, to promote access and ensure responsible conduct of research activities in these locations.
Cristina joined Complion in 2014 as the VP of Professional Services. Drawing on her past experiences in clinical research, she directs tactical product plans for Complion’s software platform and manages long-term strategic planning for product development. As the leader of the Customer Success team, she also oversees all client implementations following best practices, from onboarding and system validation through training and ongoing support.