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Integrated Stability Studies

Oasis Integrated stability module is a powerful feature-rich module that manages the entire stability testing process, it is a comprehensive solution and is compliant with current regulatory guidelines as per FDA. Stability module efficiently handles all types of stability studies as follows:

  • • Accelerated
  • • Long term
  • • Intermediate

The system ensures study specific to the protocol including pull schedules, experiment conditions, tests, cycles and test specifications. Provision is available for user to load the batches associated with that study and samples are executed on the basis study protocol.

"Under integrated set-up with LIMS, the initial condition data/results for routine production batch are automatically fetched on summariesfrom sample management module."

A set of standard reports are delivered with the system for reporting of the stability protocol and its associated results. There is a provision to keep track of stocks including consumption records of stability samples. Option is provided to print stability sample bin card. Graphs of stability data have facility for plotting data.

Optionally, the system is also capable of producing projected shelf life trend analysis.

Alerts and reminders screen includes pending for withdrawal, study etc.

Oasis also has Stability software that can be used as a standalone system or as an integrated system complementing LIMS, and other systems such as ERP/MES etc.

Stability management system improves efficiency, reduces risks and provides a significant time savings.

Stability studies management functions include - Stability Protocol, Stability Bath loading, Stability Scheduling Pulls, Stability Login, Stability Readings Observations, Stability Schedule Printing, Stability Work Sheet, Stability Certificate of Analysis (COA), Stability Labels Stability Status, Samples pending for Stability login, Stability Protocol Sheet, Stability Graphs.