Measured data recording compliant to 21 CFR 11 - blessing or curse?

摘要

With the advent of the "21 CFR 11" the American national authority FDA (food and drug administration) has set guidelines for electronic data recording and electronic signatures. These regulations are not, as often wrongly assumed, only valid for the food and pharmaceutical industries in the USA. They are also internationally relevant and even overlap with other industrial branches. The 21 CFR 11 will change and influence, world wide, the way safety-relevant measurement point data is recorded. What is required are new instrumentation concepts that cover both the regulatory legal requirements as well as the practical requirements of industry. Even though this will mean a number of modifications, the process instrumentation industry will, in future, gain and use all the advantages that come with installing and operating with electronic recording systems. An example of a new unit concept is the so called safety data manager, which shows how the requirements of both the FDA and the practical application can be successfully brought under one hat.