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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both traceability and efficiency – but compliance with regulations like Code of Federal Regulations Part 11 and European Union GMP Annex 11 is essential.
In this article, we discuss what implications these regulations have on workflows using gel and blot imaging systems to capture, analyze, and document images. We cover what to consider, what to look out for, and how to stay confident that workflows are—and remain—compliant.
April 22, 2021