QuBAS Bioassay Software
QuBAS is a feature rich statistical analysis software package with all of the commonly used statistical methods for relative potency and ELISA assays.
QuBAS has a highly intuitive graphical user interface allowing very rapid analysis method design.
QuBAS can be set to automatically import from a pre-specified folder location on your server. When data files are saved to this folder from your plate reader, the file will be automatically imported into QuBAS and the appropriate Routine Method run with no user input and then exported into your LIMS. An unlimited amount of routine methods can be set to watch different folders freeing up lots of QC time for other things.
GMP, 21 CFR part 11 compliance
QuBAS is 21 CFR part 11 and GMP compliant with 2 stage electronic signatures for locked down routine GMP analysis, and for reports.
Quantics have provided all the statistical functions and system and sample suitability tests required for US and European regulatory submissions, all pre programmed and selectable by simple drop down menus and drag and drop functions. No user programming is required, greatly reducing the QA time associated with checking the analysis parameters are correct.
Simple to use, requiring little training
QuBAS is very simple to use. It is set up as an internal website on your company’s server systems, and accessed using a Chrome or Firefox browser. It looks and feels like a modern App.
It is highly structured and intuitive, and very little training is required to be able to use all the functionality.
Automatic trending of all data
All results in the Development record, and all results run in the “Routine” locked GMP mode are automatically available in the monitoring room. An outlying point can be explored and the original full assay report for that analysis downloaded directly from the trend graph.
The results can be trended against time, but also against any other metadata that has been collected, such as operator ID, or critical reagent lot number. In this example, there appear to be 2 distinct groups of relative potency results. Changing the trend plot to show operator indicates that this is not the cause of the problem. Changing again to show critical reagent batch number reveals batch 002 as the issue.
Not only does this mean that there is no local installation that requires GMP control or IT maintenance, it also opens the possibility of pharma companies providing a VPN link to contract manufacturers so that all data analysis is done on the pharma companies QuBAS systems, and is thus accessible and visible at all times.
Diverse self-checking pair programming CrtV™
The QuBAS QA and QC system is based on the same underlying computer technology as the AirBUS A350 aircraft (CrtV) which means no user validation process is required, even for GxP work. Each analysis report is created with its own full audit trail and real time validation record. CrtV was originally developed by Quantics for in house use for GxP analysis. The MHRA inspection auditor described the process as “innovative and elegant” and fully accepted that traditional IQ, OQ, PQ is not required with this process. Results are 100% QCd by QuBAS using Diverse Self Checking Pair Programing (DSCPP).
The CrtV Automated Process
Optimal data integrity management
All data is stored and checked against encrypted hash checksums. For text “The quick brown fox jumps over the lazy dog” then the output will be:
For “The quick brown fox jumps over the lazy hog” then the output will be:
The animation above demonstrates how QuBAS uses checksums. When data is stored to the database, a checksum is created, encrypted, then stored in a separate part of the database. When the data is retrieved from the database, a new checksum is created, the original is retrieved and de-cripted, and the two are compared. If they are identical, the data can be used. If not, then the data has been changed and a data integrity error is reported.
Within QuBAS this process occurs for every data item stored – all numbers all results, all text elements and audit trail elements. QuBAS guarantees that altered data will not go unnoticed.