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 […]
Life Science Manufacturing Solutions. Protecting your Data One offering in our portfolio of data management solutions is our MES IT product, which has three major advantages to offer shop floor data collection and archival in the Life Science business: 1.) Validation to GAMP 5 Procedures. The process of collecting and archiving […]
Mitsubishi Electric automates life science applications. Mitsubishi Electric’s Factory Automation products are well established in processes from secondary packaging through to processing applications, and increasingly into life science applications. For example by extending the use of robotics into surgical processes; controlling ozone sterilization for medical instruments and even in the production of replacement body […]