How LIMS Ensures FDA 21 CFR Part 11 Compliance
21 CFR Part 11 describes the Food and Drug Administration’s (FDA’s) regulations for electronic records, and electronic signatures. 21 CFR Part 11 is designed to ensure that electronic records can be relied upon in the same way that paper and handwritten documentation, and associated signatures, have been. It has been widely implemented where electronic systems are in place and failure to comply can lead to FDA citations and issuing of warning letters.
