HMI helps meet the requirements of FDA 21 CFR Part 11
GOT2000 meeting the requirements of FDA 21 CFR Part 11 This regulation establishes 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. Part 11 applies to all GxP (i.e. GMP, GLP and GCP) IT systems […]
Read more
