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?