Pharmaceuticals and Life Sciences
Production compliance, control and traceability
Conforming to the regulations established by agencies in other countries is critical to pharmaceutical, biopharmaceutical, and cosmetics industries, as well as maintaining manufacturing standards and ensuring products’ traceability. For these purposes, companies need an efficient control and supervisory system. With over 40,000 systems installed worldwide and thousands of customers, 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, customizable solutions for real-time supervisory control that comply to FDA’s 21 CFR Part 11 Regulations, featuring tools 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;
System validation, according to Good Automated Manufacturing Practices (GAMP ) and using the tools’ native resources.
