On June 22, 2016, at the CPhI International Pharmaceutical Administration Q&A held by the Shanghai New International Expo Center at the 16th World Pharmaceutical Raw Materials China Exhibition (CPhI China), Deputy Director Sun Jinglin of the CFDA Food and Drug Inspection and Inspection Center published Special lecture on China's drug inspection situation and outlook.

At the meeting: China's CFDA regulations on data integrity will be introduced soon, and the "data integrity" officially changed its name to "data reliability."

The following is the author's point of view:

Regarding "integrity or reliability", what is the difference between Chinese and Chinese? Which kind of name is more accurate, more scientific, and more reasonable, of course, everyone is inconsistent, "data reliability" literally understands "may be" more accurate.

reliable:

1 can be trusted, can rely on: he is loyal and honest, very human.

2 true and credible: this message ~ no ~?

Let’s see what is the data:

Data is the result of facts or observations, is a logical induction of objective things, and is an original raw material used to represent objective things.

Data is the representation and carrier of information, which can be symbols, words, numbers, voices, images, videos, and so on. Data and information are inseparable, data is the expression of information, and information is the connotation of data. The data itself has no meaning, and the data becomes information only when it affects the behavior of the entity.

Data can be continuous values, such as sounds, images, called analog data. It can also be discrete, such as symbols, text, called digital data.

The data should be the “expression and bearing” of all the “information” formed by the pharmaceutical enterprises from all aspects of the “human-machine method test ring”, from the whole process of drug manufacturing and the whole life cycle.

Data, only the complete "ALCOACCEA" data, we can call it "real, credible, dependable..." and of course completely "reliable."

Therefore, "data integrity", only "complete" data is not enough, all data must be guaranteed "reliability": real, safe, traceable, usable!

Incidentally, data integrity and reliability are the most basic requirements of GMP.

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