is being presented by Dr. Ludwig Huber, Director, with LabCompliance and airs on Tuesday, April 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com
After more than 15 years the EU has released a new final version of Annex 11. Together with the updated EU Chapter 4 on documentation, it forms the EU equivalent to FDA's Part 11. Compared to the older version, it has more details and some very specific requirements. It addresses the regulatory needs of modern IT equipment, and when implemented correctly, it also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments.
This audio conference presentation provides attendees with an overview and a good understanding of the Annex 11 requirements, and also provides recommendations and tools for cost-effective implementation.
