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9 Pitfalls to Avoid During the Document Control Process

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"9 Pitfalls to Avoid During the Document Control Process"

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.

Offered Free by: MasterControl Inc.
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