Why my electronic “Document Control System” may only be a “Document Management System”

Many companies have implemented an electronic document management system, for meeting regulatory requirements. Once implemented, they discover there are manual processes that must be put in place to comply with these regulations.

The problem is that many of these systems don´t ensure electronic and hard copy documents are properly controlled. During a recent FDA investigation, a small biological company learned how much functionality was missing from their document management system.

In this article, Kevin Bogert provides an overview of what may be missing in most of the electronic “Document Management Systems” on the market based. He expands on the observations by the FDA and what companies may want to do to avoid the same discoveries during investigations.

Lingua: English

Autore

Kevin Bogert

Kevin Bogert is currently Managing Member of Azimuth Compliance Consulting, LLC and Managing Partner of Fortekna, LLC.
He has more than 35 years of business experience, 29 of them in the life science industry, where he has been involved in global implementations of quality and regulatory systems. His background includes statistics, quality and regulatory systems, computer and process validation, and automation of manufacturing processes.