External consulting services are often required not only for the creation of requirements catalogues/URS (specifications), but also for system integration including all required interfaces, the integrated overall workflow, the entire validation process including the required documents, and finally also for final acceptance (e.g. in the form of IQ and OQ). Especially for regulatory markets such as pharmaceuticals and food/beverages, these are extremely important and consultation-intensive topics that need to be worked through thoroughly and without gaps. Existing validation documents of standard subsystems can also be taken into account and used for the overall documentation.