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詳細
Bio4C ACE™ software provides robust control and monitoring of bioprocess unit operations. It automates manual tasks, enables remote monitoring of critical process parameters, supplies advanced process control, and facilitates regulatory compliance. Designed to be intuitive and secure, it allows users to run their processes in either manual or automated mode.
Recipe-driven automation eliminates manual operations, increases reproducibility, and minimizes risk of errors. An interactive piping and instrumentation diagram (P&ID) allows users to visually monitor the process and control each component (e.g., pumps, sensors) in the unit operation’s Human Machine Interface (HMI) or from anywhere through a browser-based application.
If you are interested in learning more about the Bio4C ACE™ software, please contact us today.
Services:
Recipe-driven automation eliminates manual operations, increases reproducibility, and minimizes risk of errors. An interactive piping and instrumentation diagram (P&ID) allows users to visually monitor the process and control each component (e.g., pumps, sensors) in the unit operation’s Human Machine Interface (HMI) or from anywhere through a browser-based application.
If you are interested in learning more about the Bio4C ACE™ software, please contact us today.
Services:
- Bio4C ACE ™ Software Data Integration and Domain Integration Services
- Bio4C ACE™ Software Computerized System Validation (CSV)
- Bio4C ACE™ Software Training
- Bio4C ACE™ Software Recipe Design
- System Service Reliance Plans
特徴および利点
- Complete control: interactive P&ID allows you to switch modes, change setpoints, and control actuators, enabling you to proactively identify potential issues and automatically take corrective actions.
- Remote control: in addition to the system’s HMI, the software has a browser-based interface, allowing control of unit operations from anywhere
- Visual insights: understand your process status at a glance with real-time, critical process parameters trending
- Monitoring: alarms and instrument status are easily accessible
- Data Integrity: simple data backup and restore, and audit trails ensure data integrity
- Process Automation: recipes automate execution of instructions on the system and thereby reduce manual tasks and human errors
- Configuration Changeover: for some systems, Bio4C ACE™ software offers a switchable configuration which allows the system’s setup to be modified to accommodate different production requirements
法的情報
Bio4C ACE is a trademark of Merck KGaA, Darmstadt, Germany
試験成績書（COA）
製品のロット番号・バッチ番号を入力して、試験成績書（COA） を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
資料
How software can simplify 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compliance and provide additional benefits such as access control, audit trails and easier search and retrieval.
Continuous process verification maintains drug product quality and regulatory compliance throughout production.
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