Some actions in QuBAS are specific to the interpolation analysis, these are defined as QuBAS-IA
In Development Mode
, a user can set up and explore an analysis, changing all aspects including doses, samples to be used, analysis models and system and sample suitability criteria. The various options are version controlled and previous versions can be restored easily.
In Routine Mode
, an authorised user can lock down a Method to make it available in a controlled way for routine or regulatory use.
A Routine user can only import data, and run the analysis; there are no other options available. This mode is thus suitable for routine repetitive work. The analysis in this mode also includes a full audit trail and details of the Continuous real time Validation in the analysis report. The report is electronically signed with the details of the person who ran it, and is compliant with the requirements of 21 CFR part 11.
Monitoring Room
The monitoring room allows users to view all Routine results and all analyses committed to the development room in Development mode in a highly configurable plotting system. This allows trending of critical parameters over time, or by any other metadata variable collected.
