Bioprocessing Automation and Control Software
Bioprocesses are inherently variable and therefore maintaining conditions on a unit operation within a desired range requires carefully adjusting control parameters or actuators. Keeping a skid under optimal conditions is often labor intensive and necessitates extensive workforce training. As a result of these manual interventions, product quality may differ from run to run.
Automation and control software reduces manual tasks and risk of errors which, in turn, increases process reproducibility, and optimizes uptime. Because control software securely acquires, stores, and manages the system’s data, the data are readily available for process monitoring, analysis, and decision-making. As automation and control software often requires unique usernames and passwords and automatically maintains a timestamped audit trail, regulatory compliance regarding the integrity and reliability of data is simplified.
Improve Product Quality and Process Efficiency
Automation and control software improves run-to-run consistency and product quality and reduces human errors. The software’s precise and automated control of unit operations, for example control of the flow rate or pH, can optimize the system’s process.
Bio4C Orchestrator™ software connects individual unit operations to a centralized platform for unified monitoring of systems and processes.
Bio4C ACE™ software controls and monitors bioprocess unit operations. Designed to be intuitive and secure, it allows users to run their processes in either manual or automated mode.
Related Resources
- Data Sheet: Bio4C Orchestrator™ Software
This data sheet outlines the key benefits of the Bio4C Orchestrator™ Software as well as an overview of the dashboard, modules and requirements.
- White Paper: Facilitating 21 CFR Part 11 Compliance with Bio4C Orchestrator™ Software
This white paper provides a summary as to how Bio4C Orchestrator™ Software assists in compliance with relevant 21 CFR Part 11 sections.
- White Paper: Bio4C Orchestrator™ Software Data Integrity Assessment
This paper is focused on identifying some key aspects of the latest data integrity guidance that are applicable to Bio4C™ Orchestrator, the preventative and detection controls provided.
- Data Sheet: Bio4C ACE™ Software
This data sheet outlines the features and benefits of Bio4C ACE™ software.
- White Paper: Facilitating 21 CFR Part 11 and EudraLex Volume 4 Annex 11 Compliance with Bio4C ACE™ Software
This white paper provides a summary as to how Bio4C ACE™ Software assists in compliance with 21 CFR Part 11.
- White Paper: Bio4C ACE™ Software for Mobius® Cell Retention System Data Integrity Assessment
This document describes Bio4C ACE™ software for Mobius® Cell Retention System's adherence to the Food and Drug Administration’s (FDA) data integrity guidance.
- Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.
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