DASware control plus: purpose-built with a focus on compatibility to 21 CFR Part 11 and EudraLex Volume 4 Annex 11, assisting users to achieve regulatory compliance with criteria set forth by those standards.
• User authentication and access control: aligning with the GMP requirements to prevent unauthorized access and maintain data integrity.
• Electronic records: track and document critical action in an audit trail, gaining a comprehensive view of data integrity and compliance history.
• Electronic signatures with confidence: ensure the authenticity and reliability of critical documentation in your bioprocessing operations.
• Efficient data management: retrieval and storage of human and electronic system readable data whilst adhering to rigorous data integrity standards.
Bioreactor Systems and Software Solutions – Orchestrated for Bioprocess Control, Automation, and Analysis
DASware control is the central bioprocess software solution from Eppendorf. Beyond bioprocess monitoring and control, it enables the seamless integration of bioprocess systems, control software, data analysis tools, and automation solutions to form a complete upstream bioprocessing solution.
Key benefits
• Parallel process monitoring and control.
• Reduced complexity due to the use of one central software solution.
• Easy integration of devices such as third-party sensors.
• Simplified data sharing and improved data analysis through seamless connection to BioNsight® cloud software.
Eppendorf Bioprocess Products – application in GMP regulated environment
Download document to find out which features you can expect at minimum from Eppendorf products that are deemed suitable or compatible for GMP.
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DASware® control plus
DASware control plus single
DASware control plus
• DASware control software with 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compatibility, providing User Authentication and Access Control, electronic records, and electronic signatures
• DASware control software with 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compatibility, providing User Authentication and Access Control, electronic records, and electronic signatures
DASGIP PC version 6, with DASware control 6
DASware control 6 Process View
In the Process View of DASware control, the user finds all relevant information at a glance and can access and edit individual parameter settings.
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Product Information
DASware control plus is a bioprocess SCADA software with 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compatibility for use in clinical and commercial manufacturing. It can be used for bioprocess control using the Eppendorf bioreactor control systems, such as the bench-scale BioFlo 320 controller. DASware control plus enables individual monitoring and control of parallel bioprocesses, process automation, and advanced data analysis, providing maximum performance from experimental design to result. It offers functionalities tailored to streamline electronic record management, secure electronic signatures, and audit trail integrity.Vous trouverez plus d’informations à télécharger au bas de cette page
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Product Information
Features
Product Information
Benefit from powerful bioprocess control
• Efficiency: parallel sensor calibration, intelligent recipe management, and enhanced scripting automation.
• Performance: up to 8/16/24 vessel parallel operation, powerful charting tool, and advanced data management.
• Flexibility: configurable views and user-defined functions; In-field hardware and software updates.
• Reliability: user management and data integrity, event log and alarm functions.
• Regulatory standards: Compatible to 21 CFR Part 11 and EudraLex Volume 4 Annex 11. If you require a bioprocess control software for R&D, discover DASware control.
Expand your capabilities with the DASware software suite
DASware design, analyze, and connect are optional add ons to the DASware control SCADA software.
• Application of the Design of Experiments (DoE) concept via a full factorial DoE builder or by importing DoE designs from third-party DoE tools.
• Seamless integration of external lab devices to the bioreactor for process automation and feedback control loops.
• Integration into process control systems and legacy corporate historians for company-wide access to all relevant bioprocess data.
Your data is simply there
Bioprocess data can be seamlessly transferred from DASware control plus to BioNsight cloud software.
• Enables for remote monitoring and analytics.
• Enables data contextualization across devices, runs, and sites.
• Data preparation for AI-based analysis.
Easily customize your process control with graphical programming
• Ease of use: drag-and-drop interface allows users to create and modify workflows by linking functional blocks visually, reducing complexity compared to traditional scripting or coding.
• Improved accuracy: visual workflows help users spot logical or sequencing errors early, minimizing process disruptions and improving overall accuracy.
• Enhanced accessibility: users can quickly learn and deploy workflows, increasing operational efficiency and responsiveness to process changes.
• Transparency: automatic logging of all changes supports compliance, while revision histories allow for easy audits.
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Features
- Parallel process control with individual control of each vessel
- Integrated batch functionality for process and recipe management
- Ideally suited for Design of Experiments (DoE)
- Parallel calibration and cleaning procedures
- Customized views and user-defined functions
- Automated data export, reporting and chart creation for Microsoft® Excel®
- Professional database with managed access (Postgre SQL Server)
- OPC communication for easy integration with third-party equipment using DASware connect and DASware analyze
- Integrated analysis of offline values, online calculated values, and alarm notification
- Seamless connectivity and data transfer to BioNsight cloud
- IQ/OQ package available
