FDA
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WHITE PAPER The Heart of Automation and the Art of Innovation WHITE PAPER

What is the FDA? In other words, it makes sure that all requirements rules and standard are met in these areas. The FDA (Food and Drug Administration) is the American agency responsible or the control and regulation of production processes in the food, pharmaceutical and chemical sectors. Why is the 21 CFR Part 11 so important? The aim of the 21 CFR Part 11 is to allow the broadest and safest usage of technology in the industrial field. In order for this to be possible, it is necessary to verify that all the procedures of the production process comply with certain requirements. To be...

What are the most important requirements of the FDA 21 CFR Part 11? The 21 CFR Part 11 sets four fundamental points to be observed. • The need to have a centralized system for managing accounts, including the obligation of access through login with a username and a password. •Automatic separation of roles (administrator, technical analyst, operator, etc.). • The presence of a standardized reporting system in order to generate accurate and complete copies of records that can be read electronically. •The traceability of each individual operation, which must be part of a historic...

Compliance points Yes (V) / No (*) Instrument/Equipment and Software shall have facility to : 1. Password policy

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