FDA 21 CFR Part 11 Electronic records and signatures .
for download into an instrument, a new batch recipe is ap-proved for production or an operator input occurs. The elec-tronic signature act is performed by user or supervisor typing in their User ID and Password. Our commitment. 21 CFR Part 11 5 Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are ...