GxP compliant Data Change Management

According the GxP regulations, all data changes (e.g. Master Data, Print Layout) must be approved by a second person (4-eyes principle). Hicof AMACENA offers full support of this requirement and is therefore entirely GxP compliant.


  • Today, tracking changes in serialization systems is not supported in most systems. Therefore, the tracking of changes is running as a parallel, paper-based process which is expensive and cumbersome. Due to the integrated workflow supported by the Hicof system, significant money can be saved.
  • Compliance to legal requirements
  • Improved quality of GxP relevant data; Less errors