Cao et al. describe their design and methodology used in constructing a system of tighter data integration for pharmaceutical research and manufacturing in this 2018 paper published in Process. Recognizing the "integration of data in a consistent, organized, and reliable manner is a big challenge for the pharmaceutical industry," the authors developed an ontological information structure relying on the ANSI/ISA-88 batch control standard, process control systems, a content management systems, a purpose-built electronic laboratory notebook, and cloud services, among other aspects. The authors conclude, after describing two use cases, that "data from different process levels and distributed locations can be integrated and contextualized with meaningful information" with the help of their information structure, allowing "industrial practitioners to better monitor and control the process, identify risk, and mitigate process failures."
The basic function of a LIMS is to track samples and store sample workflow related information from the time it enters a laboratory until it is disposed. In this blog, we highlight some important factors to be considered while evaluating a LIMS solution for your laboratory.
20 years ago, as a response to the pharmaceutical and life science industries wanting to increase the use of computer systems in the lab, the FDA released 21 CFR Part 11. Let's take a look at where Part 11 started, where it is now, and where it's going.