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.
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.
It is a basic requirement fulfilled by one person in some companies and a full-scale department in others, depending on the size and nature of an organization's business. While companies vary, for most of them, document control spans the following phases: document creation, approval, change control, retrieval, and obsolescence.
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.
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