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:
System validation, according to Good Automated Manufacturing Practices (GAMP ) and using the tools’ native resources.
This case presents the Elipse E3 application for automating and collecting information about the fermentation and formulation phases of the enzyme production process
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Elipse Software and its Asian partner Baufarm promoted a roadshow with the aim of presenting some of its solutions for power shortage in the sector, in five major Taiwanese citiesRead more