Demystifying the Cloud with 21 CFR Part 11 Compliance
More and more sites are using software to manage research documentation. In doing so, they become subject to additional federal regulations. 21 CFR Part 11 is the primarily regulation that governs the use of these systems. While sites are responsible for understanding and following these regulations, it can seem overwhelming for a site with limited technical resources.
By making use of a cloud-based system, sites need not worry about having the hardware or technical resources required for a software system. However, not all cloud-based systems are the same. Knowing and understanding which services vendors provide that align with Part 11 is critical to adhering to the regulation
Jim Wetzel, Senior Project Manager at Oklahoma Heart Hospital and Rebecca Santorios, VP of Governance, Risk and Compliance at ByteGrid will review what sites need to know about maintaining Part 11 compliance. This session will explore site’s responsibilities concerning Part 11 compliance and their hosting providers, including what must be done to meet Part 11 compliance and ensure information security.
During this webinar, you'll learn:
- Overview of recent trends related to the use of cloud-based software in clinical research
- Overview of FDA requirements for Part 11 compliance and recent guidance on site responsibilities
- Understand site responsibilities associated with selecting and using cloud-based applications
- How research sites can successfully implement a system and comply with Part 11
About the Speakers:
Jim Wetzel, Senior Project Manager at Oklahoma Heart Hospital
Jim Wetzel serves as a Senior Director for the Oklahoma Heart Hospital. He specializes in technology services for clinical trials, training, and clinical trial optimization. Jim applies an in-depth understanding of information technology and an understanding of major software products including EMRs, EDC, ePRO, CTMS’s, and other clinical trial platforms to further the goal of efficient clinical trials. Jim has worked in the clinical trials and technology industry for over 20 years.
Rebecca Santorios, VP of Governance, Risk and Compliance at ByteGrid
Rebecca Santorios is the VP of Governance, Risk and Compliance at ByteGrid. She is responsible for ensuring adherence to applicable regulatory statutes at ByteGrid’s data center facilities including Global GxP, FDA, Health Canada, HIPAA/HITECH, FISMA, FedRAMP as well as financial and government regulations and standards (ISO 9001, SSAE 16, EHNAC, ISO 27001, NIST 800:53, HITRUST). Ms. Santorios oversees the seamless, compliant integration of customer systems into ByteGrid's qualified infrastructure. She also monitors and improves ByteGrid’s Quality Management System (QMS). Rebecca has a background in biochemical engineering, with additional studies in system engineering, and over 15 years of experience implementing and validating computerized systems in the GxP & HIPAA space. Rebecca is an active member of ISPE and is an ASQ CQE.