DI/DX solution package "FIDIUS"

ALCOA+ compliant DI support for pharmaceutical manufacturing equipment, achieving centralized management of critical data collected from equipment and user information.

Due to global quality issues in manufacturing pharmaceuticals with opaque quality data and the need to align with PIC/S (global inspection standards), domestic GMP regulations are being revised, which requires a response to data integrity (DI) in the pharmaceutical industry. "I want to implement DI and utilize data, but I don't know how." "There are limits to ensuring DI manually, and there is a need for digitization and automation." In response to these challenges, we propose 'FIDIUS,' which incorporates various functions that electronically realize DI compliance according to ALCOA+ and enables centralized management of information. 'FIDIUS' is equipped with a data collection SCADA that covers the functionalities required in the pharmaceutical industry, as well as features that allow centralized management of multiple equipment data and user information. [Overview of the 'FIDIUS' Solution (Partial)] ■ FIDIUS Pharma-Core - Central management server for data and users ■ zenon - Base SCADA software for data collection *For more details, please feel free to contact us.

Document and Data Management