ALCOA is a standard used by FDA and WHO for data integrity can this be used generically in IT sector as well for maintaining the data integrity?

20 October 2016 1 1K Report

ALCOA is a compliance used in life sciences and pharmaceuticals for maintaining the integrity of the data. i am thinking of using this standard in IT sector for maintaining the integrity of the data.can anyone please suggest do we use it or not or is there any standard available for data integrity in IT sector.

Bruce Neagle

It depends on what the data is being used for! If it is the pharmaceutical or biological arenas it must be compliant with 21 CFR part 11 (or EU equivalent depending on where you are selling). Many places also look at GAMP5.

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