Dissolution testing software for compliance and efficiency
Ensure data integrity and streamline compliance with a robust dissolution testing system that offers automated control and comprehensive reporting, simplifying quality control and enhancing efficiency in pharmaceutical development processes.
The Disso.NET 4 by ERWEKA GmbH is a comprehensive dissolution testing software designed for pharmaceutical and biotech laboratories. It excels in managing dissolution testing workflows with features that ensure data integrity and quality control. Tailored for compliance with 21 CFR Part 11, it integrates seamlessly with ERWEKA’s range of dissolution systems, including online, offline, and thermo systems, enabling precise evaluation of pharmaceutical tablets, nutraceuticals, and supplements. The intuitive interface supports multi-user environments, offering configurable user roles for secure access control. Disso.NET 4 automates documentation and reporting processes, generating extensive, customizable reports that enhance laboratory efficiency. With robust data management features, it ensures secure data backup and retrieval via its industry-standard MS SQL database, while the software’s comprehensive audit trail thoroughly documents all changes for regulatory compliance. Additionally, its strong system suitability testing and multitasking capabilities guarantee high reliability during operations, making it a valuable tool in R&D and quality control environments.
Benefits
- Enhances data integrity and compliance with seamless 21 CFR Part 11 adherence.
- Optimizes laboratory operations by streamlining data management and reporting processes.
- Increases user efficiency with an intuitive interface supporting multi-user roles.
- Ensures precise quality control through continuous system suitability testing.
- Protects data integrity with reliable MS SQL database and comprehensive audit trails.
- Applications
- Supplements,Vitamins,Pharmaceutical tablets,Nutraceuticals,Biopharmaceuticals
- End products
- Biologic drugs,Vitamin c tablets,Fish oil capsules,Probiotic supplements,Herbal supplements,Extended-release tablets,Protein powder supplements,Multivitamin tablets,Effervescent tablets,Chewable vitamin tablets
- Steps before
- Steps after
- Report Generation,Data Backup,Review and Approval
- Input ingredients
- dissolution systems,UV-Vis spectrophotometer,HPLC systems,user data,methods,media,filters,measurement,evaluation,medium preparation
- Output ingredients
- reports,audit trail,method data,calibration data,raw data,PDF export,XLS export,XML export,analytical reports
- Compliance
- 21 CFR Part 11
- Automation
- RoboDis II+ system integration
- Data Export Formats
- PDF,XLS,XML
- Database Type
- MS SQL
- Language Support
- English,German
- Multi-user Support
- Operator,Senior Operator,Administrator
- Audit Trail
- 21 CFR Part 11 compliant
- System Compatibility
- UV-Vis spectrophotometer
- Data Handling
- Automatic log off
- Compliance
- 21 CFR Part 11
- Automation level
- Manual / PLC / SCADA
- Cleaning method
- CIP / Manual
- System control
- Multi-user support
- Data management
- Database with back-up and restore
- Language support
- English / German
- Audit trail
- Comprehensive tracking
- Integration capability
- Active Directory connection
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- 21 CFR Part 11 Compliance
- Yes
- Audit Trail Compliance
- Yes
- CE Marking
- Yes
- FDA Compliance
- Yes
- GMP Compliance
- Yes
- Control panel type
- Intuitive screens
- Compact footprint
- Yes
- Discharge method
- Data export in PDF,XLS,XML
- Control Panel Type
- Intuitive Screens,Logic Top to Bottom Approach
- Integration Possibilities
- Integration with Online,Offline,On-/Offline,HPLC Systems
- User Roles Configuration
- Operator,Senior Operator,Administrator
- Language Support
- English,German,Easily Addable Languages
- Customization of Reports
- Customized Logos,Compact Analytical Reports
- Market info
- ERWEKA is renowned for manufacturing high-quality pharmaceutical testing equipment, including dissolution testers, tablet hardness testers, and other analytical instruments, known for their precision and reliability in laboratory testing environments.