Automating Document Change Control in FDA Regulated Environments: Increase Efficiency, Ensure Compliance and Improve Profitability

The purpose of document change control systems is to ensure that manufacturers build products that are safe and reliable. Good Manufacturing Processes (GMP) presume that both the process and documentation directing the process follow pre-approved methods, and any change to these methods is both restricted to authorized personnel, and tracked for future review. All FDA-regulated companies are mandated to have a document change control system.

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