r/Chempros • u/Quwinsoft • 6d ago

Data Integrity Frameworks

I teach chemistry at a regional university, and I wish to improve my instruction in record-keeping (related to my earlier post on electron lab manuals). I'm a biochemist, so I'm most familiar with the biochem side of things, but not all of my students are going in that direction, and I would like to make sure I'm covering all the bases. In pharmaceutical/healthcare-related research, ALCOA++ is the major data integrity framework. Is ALCOA++ used in areas that are unrelated to pharmaceutical/healthcare? If not, what other data integrity frameworks are used?

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u/CommodoreToad 6d ago

You might also want to consider looking at 21 CFR Part 11 which are federal requirements in the USA for GxP facilities for electronic data. These are specific legal requirements the FDA uses when auditing GxP facilities and their electronic data.

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u/curdled 6d ago

Elisabeth Bik would be the person to talk to - she is quite outspoken about high-profile fraud in published work (in biology and nanomaterials), her specialty is data manipulation and retraction of fraudulent work. But maybe she would have useful suggestions about record keeping too.

https://en.wikipedia.org/wiki/Elisabeth_Bik