Auditing Computer Systems for FDA and International Compliance
February 13, 2019 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:4169154458
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic evaluation, vendor agreements, incident management and structured back-up. Just in the last three years more than 30 warning letters mentioned violations for computer systems, some of them with disastrous consequences for the companies. Most companies have a computer validation and Part11 compliance program in place, but either it is wrongly designed, not implemented or not followed.