Why Your Document Control System is Obsolete

For many years companies have implemented document control systems that had the ability to manage the version of the document throughout their life cycle. As documents were approved the process would notify users that a new version is available and obsolete copies should be discarded. That changed with the newer version of ISO and the issuance of the FDA’s data integrity guidance document.

In this paper, Kevin Bogert examines why most document control systems on the market do not meet the requirements of a document control system. He provides insight into what is required of a document control system. His other paper, "Data Integrity: a Document Control Challenge", he examines what is missing from document control systems based on FDA's guidance document related to data integrity.

Kevin Bogert is currently Managing Member of Azimuth Compliance Consulting. He has more than 35 years of business experience, 30 of them in the life science industry, where he has been involved in global implementations of training, quality, and regulatory systems. His background includes statistics, quality and regulatory systems, computer and process validation, and automation of manufacturing processes.

He can be contacted at: kbogert@azimuthcc.com