Automating Document Control ProcessesSource: MasterControl
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 management systems.
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 insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with FDA requirements and improve overall profitability.