Comply with the regulations established by agencies, maintaining manufacturing standards and ensuring products’ traceability is critical to any pharmaceutical, biopharmaceutical and cosmetics industries. Elipse Software can provide you with life sciences solutions applicable to any step in the process, for production compliance purposes and other utilities.
Elipse products provide you with a set of flexible and customizable solutions for real-time supervisory control that comply to FDA’s 21 CFR Part 11 Regulations. Elipse E3 offers resources for:
- Traceability and security of historic data;
- Analyzing the quality of manufactured items, including paretos and statistical process control (SPC);
- Support to electronic signature for sending commands, issuing orders, requesting reports, or any other points that require user control;
These tools allow also to system validation, according to Good Automated Manufacturing Practices (GAMP ) and using the native resources.
