Comments on: Is Your Labeling System Really http://www.prisymls.com/labeling-regulations/compliance/ Welcome to PRISYM ID’s blog, where we share our experiences with you from the life sciences marketplace. Our team will regularly discuss the types of issues they come across when working with some of the world’s largest medical device, pharmaceutical, healthcare and clinical trials companies. The blog covers news, events, opinion pieces and articles. Wed, 30 Jun 2010 19:04:55 -0500 http://wordpress.org/?v=2.9.2 hourly 1 By: Bob Tilling http://www.prisymls.com/labeling-regulations/compliance/comment-page-1/#comment-15 Bob Tilling Mon, 15 Dec 2008 08:23:06 +0000 http://www.prisymls.com/blog/?p=78#comment-15 Labelling is one of the top areas companies fail an FDA audit. As a consultant on FDA 21 CFR Part 11 compliance I have dealt with this exact scenario many times. Your presentation reflects my own experience of the most common areas for failure within the labelling process. In my opinion custom in-house designed labelling solutions based on general labelling software present a far higher compliance risk to Life Science companies compared to using purpose designed FDA Compliant labelling software Labelling is one of the top areas companies fail an FDA audit. As a consultant on FDA 21 CFR Part 11 compliance I have dealt with this exact scenario many times. Your presentation reflects my own experience of the most common areas for failure within the labelling process.

In my opinion custom in-house designed labelling solutions based on general labelling software present a far higher compliance risk to Life Science companies compared to using purpose designed FDA Compliant labelling software

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