Data from the monitoring of production environments is attracting tougher regulatory scrutiny.
79% of FDA warning letters cite 'Data Integrity', increasing by over four times between 2015 & 20181.
There is an increasing demand for a risk assessment to govern how culture plate reads are performed — and when second analyst verification will be used.
Manual counting and recording processes are subject to human errors and fatigue.
There is often no long-term record of culture plates that are destroyed after reading, creating traceability challenges.
There can be interpretation inconsistencies between analysts.
There is potential to not visually detect microbial growth that presents a risk to critical production areas.
The APAS Independence is a scientifically validated instrument that provides improved data capture and resulting of environmental monitoring culture plates.