High frequency of CAPA related observations in Warning Letters.

Posted on July 18, 2013

Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating to Corrective and Preventive Actions (CAPA) deficiencies 21 CFR 820.100. Of these 29 Warning...

Electronic Document Management Systems

Posted on June 13, 2012

Over the past few years we have seen FDA warning letters in relation to non-compliant Electronic Document Management Systems (EDMS). Of particular concern seems to be the use of "off the shelf" software such as Sharepoint. EDMS are becoming increasingly popular because they automate many of the document processes that used to be done by hand. However, configuring and validating a new document management system can be an extremely challenging task, not to mention very expensive. Because of this, many firms are currently using unvalidated document management systems. Below is an excerpt from an FDA warning letter sent to an undisclosed firm:

"Off-the-shelf software (Microsoft SharePoint) is being used by your firm to manage your quality system documents for document control and approval. However, your firm has failed to adequately validate this software to ensure that it meets your needs and intended uses. Specifically. at the time of this inspection there were...