With exciting features such automatic data transfer, metadata trending and real-time validation, QuBAS 3.0 has all the tools you need to build your analysis, your way.
QuBAS 3.0 delivers unrivalled flexibility for early-stage development. Using the quick fit function, a basic analysis can be run in under a minute, allowing developers to play with their data free of restrictive workflows.
Statistical support from Quantics
QuBAS 3.0 is supported by Quantics’ team of statisticians, who have provided expert statistical consultancy for the life science, pharmaceutical and medical device industries since 2002. With Quantics, you can have 100% confidence that your statistics are robust.
Intuitive view of allocation
Complicated data / plate layout? Switch to View and QuBAS will reorganise all information into simple tabular form.
Auto-import and export
QuBAS 3.0 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 imported automatically into QuBAS and the appropriate analysis run without user input. The report is exported as a .pdf file as well as a variety of formats suitable for LIMS, all compliant with 21 CFR pt11, GMP.
IT-friendly: with access from anywhere
QuBAS is set up as an internal website and accessed using a Chrome or Firefox browser from any device on your network. It can also be accessed from anywhere in the world over a VPN link to the company’s server. Not only does this mean that there is no local installation that requires GMP control or IT maintenance, it also opens the possibility of providing a VPN link to your contract manufacturers so that all data analysis is accessible and visible at all times.
The record of development is an interactive record of key analyses and design layouts.
Key (milestones) during the development phase are captured and the report can be exported for inclusion in the assay record of development for submission.
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 easily selectable for use. 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 3.0 is built to be user-friendly. With a highly structured and intuitive UI, it requires very little training to confidently use all its functionality. It looks and feels like a modern app with no need for coding or complex functions.
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.
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
QuBAS uses a unique system of 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 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% QC’ed by QuBAS using Diverse Self Checking Pair Programming (DSCPP), part of our CrtV method.