UK/European 21CFR Part 11 Equivalence

Hi all,

Does anyone know of any UK (MHRA) or European (EMEA) regulation which is similar to or equivalent of 21CFR Part 11?

Presently our company takes a blanket approach to RERS, applying 21CFR Part 11 to all systems which fall within its scope - I’m of the opinion that a lot of effort could be saved not performing assessments/remedial actions upon systems which aren’t used in the manufacture of product for FDA regulated markets.

Any opinions?

use this link

and go to Annex 11 computer system