Now a day’s regulators looking for control on the product
/system recipe. Recipes are very critical
part of process. Because process are control through validated recipe. If firm calming
that their system complying 21 CFR par 11/EU annex 11, in that case they should
ensure that their system is capable for following mentioned control,
a) System
should available with the audit trial and it should capture in case any change
in individual recipe
b) Recipe
edition, modification and deletion to be assign to only administrator, these
mentioned options should not accessible to other authorization level.