21 CFR Part 11: 20 Years and Counting
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. The ruling on using electronic records and signatures in place of their hard copy counterparts has since impacted not only how we collect, analyze, report, and transmit data, but also the technology we use to do it and the processes and procedures we follow day to day.
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