Every company in the regulated environment of GxP requires a Quality Management System (QMS) that transforms the regulations for validation and system operation into company specific guidances.

Beside of the necessary "Standard Operating Procedures" (SOPs) a set of templates is useful in order to explain the "how" of validation (structure and content of examples). The well-tried templates can be adapted to the needs of your company.

Young companies working under GxP have most benefit from rapid provision of appropriate standard operating procedures and templates. Instead of time consuming reading of the official guidelines they can get a quick help by introducing a prepared IT-QMS.