Automating Document Control Processes to Comply with FDA and ISO Requirements: Increase Efficiency, Ensure Compliance and Improve Profitability

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. ISO standards and FDA regulations mandate that all companies that manufacture regulated products have a document change control system.

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