How to establish a Document Control System to ensure ISO and FDA compliance

Many companies implement an electronic document control system, for meeting regulatory requirement. Or at least they think they are meeting.

The problem is that many of these systems don´t ensure documents are properly controlled. They are not focusing on the review and approval process, version control, audit trail, and electronic signature. There is a huge potential for documents to be freely printed, used without approval or even to be lost.

In this webinar, Kevin Bogert look on what may be missing in most of the electronic “Document Control Systems” on the market. He shows the way companies need to follow to overcome these challenges and ensure regulatory compliance.

Langage: Anglais

Auteur

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.