In a regulated environment, the document control process can either be an obstacle course replete with pitfalls, or it can be a smooth ride to a successful product launch. If you want the latter, you need effective control in every phase of the life cycle of every important document.

In its simplest form, document control refers to procedures for approval, distribution, and change of a document and the designation of a person or people to implement those procedures. 21 CFR Part 820, a key regulation for medical device firms, provides a good example of the expectations of the U.S. Food and Drug Administration (FDA) and similar agencies worldwide in terms of document control.

In this white paper, we will discuss common issues in every phase of the life cycle of a document. I will offer insights based on my experience developing software solutions for regulated companies and my interactions over the past decade with quality professionals who are responsible for document control and digitization of data today, the regulation is more relevant than ever.