EDINBURGH, U.K.–Mar. 10, 2021–Quantics Biostatistics

Quantics announce an industry changing approach to manual import/export procedures of clinical and laboratory data using our proven Continuous Real-Time Validation (CrtV) software platform.

QcBOT delivers a fully automated approach to data transfer processes in regulatory environments removing potential risks of human error. CrtV guarantees the “QC” check of every number every time, not just a sample of the data which is the status quo in many laboratory environments.

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 QcBOT using Diverse Self Checking Pair Programing (DSCPP).

QcBOT is a GAMP 5  designed for each user requirement. Hidden within QcBOT, the imported data is processed by 2 completely independent programs, Independently written during development by two different programmers, in different programming languages,  the results are compared, again using a DSCPP process and only if all agree is the data passed.

Once QcBOT is installed on your server, a simplified IQ process can be followed to check that QcBOT is installed correctly and can access the input and output locations, along with a test to show that QcBOT does what it is designed to do.

Once tested (and therefore validated) QCBoT can be left to run without manual intervention.  After the initial test, the paired “user” and “QC” programs will ensure that QCBOT always performs the way it was intended; in the extremely rare case of a mismatch, no data is output.

Laboratories using QcBOT have no computer control requirement for the process because system change inherently impacts the “black box” of QcBOT. A system change would have to change the option of the “user” program and the “QC” program in entirely different ways (due to the programs being inherently different) such that the results still agreed. This, in practice, is a very unlikely circumstance.

Get in touch to discuss your manual data transfer processes to find out if QcBOT can save you time, money and mistakes.