What’s New in QuBAS 1.2
Upgrade and use today without the need for IQ, OQ, PQ due to our unique Continuous real time Validation (CrtV).
QuBAS ensures backwards compatibility with previous versions.
All results including relative potency, constrained and unconstrained model fit parameters, system and sample suitability test values (and criteria settings) from the Routine analysis mode, or that have been saved to the development record in Explore mode, can now be plotted on a trend graph. These values can be plotted against date of analysis, or against any Metadata value available in the data, such as manufacturing site, critical batch reagent ID, operator ID, or method version number.
Records to be displayed can be sorted and filtered in many ways to achieve the plot required.
Plot of RP Vs Date of analysis indicates a step change on 22 December:
Exploring the plots quickly shows that the problem is connected with the batch of a critical reagent:
Method for Ratios
QuBAS 1.2.0 now has the option to choose either the Delta method (default) of Fieller’s theorem for the calculation of confidence intervals (CI) for ratios.
The Delta method is based on a Taylor expansion and is generally applicable to any function between two random variables. Fieller’s Theorem was developed specifically for the ratio of the means of two variables only.
In general both methods give very similar results, however in some circumstances the Fieller’s theorem is unstable and can give non-sensical results. For this reason, CI calculated with Fieller’s Theorem should be inspected carefully before use. See https://en.wikipedia.org/wiki/Fieller%27s_theorem
Slope Ratio Tests
Slope ratio significance and equivalence tests are now available for all methods for use as System or Sample suitability criteria. The CI is calculated using the Delta method (default) or Fieller’s Theorem.
Enhanced Fraud Prevention
Repeated attempts at logging in without the correct password / Username combination result in the account being locked and a notification email being sent to the system administrator.
Dual Report Sign Off
Every report created in the Routine GxP mode now carries the e-signature of the User who ran the analysis in QuBAS, and either the e-signature or manual signature of an Audit user. The second signature is applied by an Audit user logging in and navigating to the Audit room Report sign off page: