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Pharmaceutical companies must meet the requirements for the manufacture of new products and their
responsibility for public health and safety. Legal requirements such as those of GMP (Good Manufacturing
Practice in Europe), the CFR (Code of Federal Regulation in the United States) and the FDA (Food and
Drug Administration in the United States) led to emergence of frames of reference such as the 21 CFR Part
11 criteria and the GAMP (Good Automated Manufacturing Practice) for validation of automation systems
in the pharmaceutical and medical fields. Beyond the requirements, certain control bodies produced their first “Warnings” for companies, threatening to suspend any trade in products whose manufacturing processes were not validated.