Life Sciences companies are regulated by the FDA and must abide by the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). A cornerstone of these regulations is to establish an internal oversight function; typically called Quality Assurance or QA. QA has a number of responsibilities within a typical company including the review of execution records to ensure completeness and consistency. If the company uses paper execution records or captures raw data in a spreadsheet, this review can be onerous. It is not atypical for records review to be the rate limiting factor in a regulated factory or lab.
In a recent project, our customer was automating an immunohistochemistry process. The new design used a liquid handling robot to pipette samples into 96 well plates using a serial dilution scheme. The plates were then loaded onto a plate reader where the Optical Density (OD) of each sample was measured. These data were then transferred into a locked-down spreadsheet template for reporting.
When I interviewed the lab manager about expected labor savings, I was surprised to hear that all the robotics and automation were not expected to yield efficiencies. It turns out that people are pretty good at performing sample handling tasks. According to the lab manager, the efficiency gain would come from the integrated bar code reader on the liquid handling robot. The bar code reader provided an audit trail that could be inspected by software to ensure samples were diluted, loaded, and measured correctly. All the efficiency gains came from relieving QA of the need to inspect the execution records.
Time and time again, we discover that QA has to perform a painstaking review of all execution records before a product can be used in a regulated process or released for sale. The problem can be particularly acute in the microbiology areas; where clean room and water system sampling is performed. These tasks can generate an avalanche of samples. And you will often find QA buried under the pile. It is common for product release to be held up because the water has not been released by QA. Talk about the tail wagging the dog!
Wouldn’t it be great if your QA department didn’t have to perform 100% inspection? What if they could focus on the exceptions? Imagine how your company’s operations could be transformed. Imagine how turn-around time could be reduced. And this would mean dramatically increased throughput for your lab or factory.
So how should you approach such a project? At BioIT Solutions, we start at the tail end of the process. We look at the final report and identify the data elements that comprise that report. Then, we follow each data element back to its source; paying particular attention to any transformations. We identify the critical control points; the points where the data can be perturbed. And we establish controls; either technical or procedural around each one of the critical control points.
We aim to establish an intuitive, navigable supply chain of information. A supply chain that allows scientists and regulators to follow the reported results back to the raw data and that discloses the experimental conditions. By establishing an information supply chain, you can free your QA department from 100% inspection and unleash the potential of your company.