Bio4C Orchestrator™ Software Data Integrity Assessment

Bio4C Orchestrator™ software connects different unit operations or skids to a centralized server (the Bio4C Orchestrator™ server) and collects data and displays it on a centralized Process Dashboard. Bio4C Orchestrator™ supports centralized management of alarms, users, recipes, and reporting through a browser-based user interface.

Here, we describe Bio4C Orchestrator's™ adherence to the Food and Drug Administration’s (FDA) data integrity guidance set out in Data Integrity and Compliance with Drug CGMP Questions and Answers Guidance for Industry published December 2018.