Pharmaceuticals and Life Sciences

Production compliance, control, and traceability

For pharmaceutical, biopharmaceutical, and cosmetics manufacturers, complying with regulatory requirements, maintaining manufacturing standards, and ensuring product traceability are critical. Elipse Software offers life sciences solutions for every stage of the process, supporting production compliance as well as plant utilities.

Elipse products provide a set of flexible, customizable solutions for real-time supervisory control that comply with FDA 21 CFR Part 11. Elipse E3 includes features for:

  • Historical data: ensures traceability and security of historical records
  • Quality analysis: evaluates manufactured items with Pareto charts and statistical process control (SPC)
  • Electronic signatures: supports e-signatures for sending commands, issuing orders, requesting reports, and any other action that requires user authentication

With these built-in features, you can also validate your system in line with GAMP (Good Automated Manufacturing Practice) guidelines.