The pharmaceutical quality control laboratory plays a key part in pharmaceutical production. The in-process and finished product testing need to ensure compliance with CGMP/FDA requirements.
SOPs, lab records/logs with regard to the test data , methods validation, lab equipment maintenance , calibration and their operation- all of these become integral to the overall quality of the production process. These will also include test failures and their analysis.
Out of spec errors can come about from the use of wrong methods/standards or wrong calculations in the lab tests; from non-process and manufacturing process errors.
As hundreds of tests are carried out across multiple samples batch-after-batch, this repetitive but very important process is prone to manual errors and an ideal case for automation.
Read more about how our cognitive engine ACE helps achieve a steep reduction in the QA-QC review cycle and the overall batch release cycle which is so important for improving the production throughput of a multi-million dollar pharmaceutical plant
This first step is critical in the automation workflow and ACE does it: