Using SharePoint as a Technology Platform for 21 CFR part 11 - A Case Study Shared by JamesRichard
Using this biotech company as a case study, the webinar charts a strategy for complying with the FDA 21 CFR part 11 regulation using SharePoint. The case study begins with an analysis of the part 11 regulation and a description of the biotech company. What IT controls would they have to implement, including policies, plans and procedures, to comply with the regulation; and what information systems would be required to support the IT controls? The webinar addresses these core activities and proceeds with a description of the qualification process of the data center. The rationale for choosing SharePoint as the compliance platform for generating and maintain electronic records and electronic signatures for FDA submissions is discussed with a brief overview of a SharePoint-based approach for:
The webinar concludes with a strategy for establishing a system validation process and with lessons learned from using SharePoint as a compliance framework for meeting FDA regulations for electronic submissions.
Why should you attend: If you are working in biotech company that will be making regulatory submissions to FDA, then what is your strategy for maintaining electronic records and signatures for FDA submissions? Your email and file share work, but is your IT department ready to comply with the FDA 21 CFR part 11 regulation for maintaining electronic records and signatures for FDA submissions? How can SharePoint be used to for generating and maintaining electronic records and electronic signatures so you can comply with FDA requirements for electronic submissions?
The webinar will follow a case study of a biotech firm and its journey down the road to compliance with the 21 CFR part 11 regulation. This firm implemented a successful approach with SharePoint as the technology platform for generating and maintaining electronic records and electronic signatures for FDA submissions. The webinar explores a strategy for starting with a basic IT Infrastructure and establishing core IT controls, qualification of data centers, and validation of a part 11 compliant document management system with integrated electronic signatures using SharePoint as a compliance platform for meeting the FDA regulation.
Areas Covered in the Session:
Who Will Benefit:Speaker Profile: