A Time for Family and Reflection
To all my readers – have a happy holiday season and a very happy, healthy and prosperous New Year.
Is Part 11 Dead? Part 1 of a series– Electronic Records
Hardly! But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on […]
