Regulatory Approved Process
QuBAS uses a unique system of Continuous real-time Validation (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, and PQ are not required with this process. This dramatically reduces QA burden, saving users valuable time and resources.
Results are 100% QC’d by QuBAS using Diverse Self Checking Pair Programing (DSCPP).
Traditional Validation is Flawed
The Traditional Process introduces some serious flaws
• Time consuming, costly and cumbersome. Significant QA & QC input required for every analysis.
• Software tested on manufacturer-supplied & user-defined datasets. “Correct Answers” usually produced by the same software, meaning issues could be common between test results and “Answers”.
• Validation performed at installation and only intermittently thereafter. An unexpected flawed run could be missed.
• Mathematics is not checked after development. Numerical errors could go unnoticed.
• Assumes system remains valid so long as no changes are made.
• Validates on one computer only, which incentivises keeping old hardware where updates might otherwise be made.
The process has to be repeated for every computer, upgrade and any change in other software / hardware.
QuBAS Continuous real-time Validation (CrtV)
QuBAS CrtV process uses Diverse Self-Checking Pair Programming (DSCPP) to perform robust validation in real time on every data set.
QuBAS analyses data simultaneously in two separate analysis engines. These engines are independently developed by two different statisticians in different programming languages. On completion, the results from the two engines are compared using a DSCPP process, and only if all agree is a report produced.
Since the engines are independent of each other, the chances of an error in one branch producing results which match those from the other are extremely small. If the results match, therefore, it can be safely assumed that those results are statistically robust.
This process validates that Engine A is installed, performing and operating correctly by comparing with Engine B, and vice versa. With CrtV, validation is completed with each and every analysis, so there is no need for IQ, OQ or PQ.
As well as validating calculations, QuBAS uses a similar DSCPP process to validate audit trail, user inputs and report generation from the results.
Benefits of CrtV
• Validation performed simultaneously with analysis, significantly streamlining the process. No user QA or QC input required.
• Calculations performed twice by independent analysis engines, meaning errors extremely unlikely to be common to both sets of results.
• Validation performed for every analysis, assuring results are correct for all runs.
• Validation is not affected by changes to system hardware or other software, meaning no re-validation is required when changes are made.
• Validation is not system dependent, meaning hardware updates can be made freely, so long as compatibility remains.
