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.
