This Webinar specifically addresses the Service Management and Performance Monitoring of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.
All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.