The FDA 21 CFR PART 11: Best Practices for Medical Device Compliance
With the advent of digitization, many global organizations, especially in life sciences and med-tech industries, have randomly shifted their data from paper to digital forms. Thanks to the stringent regulations, like US FDA’s 21 CFR Part 11 (21 CFR 11) regulation, the digitalized data forms are coming out to be accurate, efficient, productive, quality-oriented and reliable. The 21 CFR 11 regulation is a part of the Code of Federal Regulations, which establishes the US FDA regulations for electronic records and signatures.