SMART quality & compliance
GxP Compliance: Back To Basics
“Make it right today, better tomorrow”. -F. Schnettelker If a drug is being produced in a GxP compliant manner, there are various specific guidelines that must be adhered to. In principle, computer systems associated with the life cycle of a product must meet certain criteria. The pharmaceutical industry must follow certain rules: Secure logging All system activities related to research, development and manufacturing must be registered by the users. This logged data cannot be amended, even by the admin responsible. Auditing Reconstruction of decisions and potential mistakes made in the development and manufacturing of a regulated product must be documented…
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