Dissolution testing software for compliance and efficiency
In pharmaceutical development, maintaining compliance with regulatory requirements while managing complex dissolution testing processes can be a challenge. Ensuring accurate data management, system control, and thorough documentation is crucial for reliable outcomes and regulatory adherence.
Manage and control dissolution testing systems
The ERWEKA Disso.NET 4 is a 21 CFR Part 11 compliant software designed to be the perfect companion for all ERWEKA Dissolution Systems. Handling tasks from standard dissolution to qualification, it manages various connected devices such as dissolution testers with UV-Vis spectrophotometers. Disso.NET 4 simplifies complex systems into intuitive screens for easier operation. The software enables comprehensive data management, incorporating multi-user support with configurable roles and automatic log-off for enhanced security. Regular system suitability tests ensure ongoing reliability, while its JobController allows multitasking during tests. With robust documentation features, Disso.NET 4 generates customizable reports effortlessly and maintains data integrity through an MS SQL database with backup and restore options. Language support for English and German is built-in, with the capability to add more languages.
Benefits
- Ensures regulatory compliance with 21 CFR Part 11
- Simplifies control of complex dissolution systems
- Comprehensive data and user management
- Consistent system reliability through suitability tests
- Customizable reporting for paperless labs