Automating Document Control
Processes to Comply with FDA
and ISO Requirements:
Increase Efficiency, Ensure
Compliance and Improve
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Automating Document Control Processes
The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and
FDA Current Good Manufacturing Practices (CGMP) presume that both the process and documentation that directs company
processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked
for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.
Inefficient document control systems cost FDA-regulated manufacturers millions of dollars. This significant loss in revenue can
primarily be attributed to the inefficiencies that occur when using a paper/hybrid-electronic system. (Wherein document change
control is managed in a manual fashion or using a combination of both paper and electronic files.) Manual systems are error-
prone, delay a product’s time to market, and introduce product quality problems that can result in stringent regulatory penalties.
In fact, the FDA cites inadequate change management as a major cause for “Form 483” observations. Examples of common
shortcomings include documents with missing dates or missing numbering schemes, uncontrolled copies and document changes
without approvals or explanations. To eliminate these inadequacies, regulated companies are turning to electronic-based quality
Today’s quality management systems provide integrated solutions to handle everything from corrective /preventive actions
(CAPA) through change control and training. This article will focus on document control processes within the quality system
lifecycle and provide insi