Chromatography | Spectroscopy | Environmental | 21 CFR Part 11

FDA 21 CFR Part 11 is a rule enforced by the Food and Drug Administration of the US in August 1997 to regulate the use of electronic records and electronic signatures. The rule stipulates the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA.

Over recent years, the expanding number of pharmaceutical products and the increasing strictness of regulations on such products has given rise to a need for streamlining the process of obtaining approval for new products, and for enabling more efficient management of analysis data and operational records. In view of this, FDA 21 CFR Part 11 was developed with the aim of promoting the transition from the use of conventional paper records and signatures to electronic records and electronic signatures, by clarifying definitions of the original raw data and setting strict requirements for data recording and archiving.

Shimadzu are mindful of the implications the FDA rule, and have developed software solutions to meet 21 CFR Part 11 regulatory compliance.