Generally, concrete intervals are not defined in the regulations, whereas an interval of 5 years is considered to be definitely too long. The companies should set their own intervals, above all with regard to change management. In this context, a yearly assessment is recommended – e.g. within the framework of the required self-inspections – during which the changes are again assessed (many small changes that do not give cause for revalidation individually may in their sum be reason enough for revalidation). In the case of major changes (e.g. an upgrade to a new SAP release), a revalidation must however be carried out.