Scientists working in biotechnology and pharmaceutical cell culture laboratories increasingly rely on electronic systems for data management, necessitating a shifting regulatory compliance landscape. Electronic records must meet specific criteria to be equivalent to paper records, such as those laid out by the US Food and Drug Administration (FDA) in the 21 code of federal regulations (CFR). A digital microscope approach offers researchers the advantage of more consistent and efficient electronic documentation of cell culture results while meeting regulatory criteria such as audit trails and user management.
Download this article to learn about the recommendations of 21 CFR Part 11 from the FDA and how a digital microscope approach helps users follow the recommendations with improved cell culture management.
