THE MOST COMMON QUESTIONS ASKED
Should QA do any validation at install?
Validation of the QuBAS installation is not required. Any validation records that were created would be completely superseded at every analysis, so there is no need to do it.
What about QA for upgrades?
The same applies – just download and use. Quantics ensures that every upgrade will produce the same results when run on historic data sets by a) only updating one half of the DSCP at a time, and b) automated testing on more than 2000 data sets every day. The update process provides an option to automatically check the new version against your old data for added peace of mind if you wish.
How will QA know that the real-time validation has passed?
An audit report is included on the final page of every QuBAS report. This contains details of the validation and other aspects of audit.
Is QuBAS cloud-based?
QuBAS can be deployed either as a local instance installed on your company’s servers, or as a cloud-based instance installed on AWS servers maintained by Quantics.
What about QC of results?
Every calculation is automatically QC’ed by the DSCPP process. No further QC is required.
Is QuBAS 21 CFR part 11 compliant?
Yes. QuBAS can be used as a part of a 21 CFR part 11 compliant system.
How do regulators view the CrtV system?
The Continuous real time Validation (CrtV) processes incorporated into the QuBAS software have been used for several years in-house at Quantics for GxP regulatory work. Quantics is a member of the MHRA GLP scheme and as such is regularly inspected by the MHRA. At every inspection the MHRA have fully approved the CrtV process, and agreed that traditional validation processes are not required. One inspector described the system as “innovative and elegant”.
The processes have also been audited with no adverse findings by numerous clients for GxP work, The MHRA have told us that anyone with concerns can write to GLP@MHRA.gsi.gov.uk.
Quantics have been invited by the MHRA to a meeting of GLP and GMP inspectors to explain the CrtV process, so that inspectors know what to expect when they audit companies using QuBAS.
How do I cite QuBAS?
Quantics Consulting Ltd, “QuBAS v3.0.1.” Edinburgh, UK. 2023
How do I find my machine ID?
It’s a long character string that is shown on the home page of your QuBAS installation.