We conduct online internal and external audits as well as Mock audits. We prepare your employees for such audits with authorities and notified bodies under realistic conditions.
We also instruct suppliers and service providers and show them which requirements they have to fulfill in a regulated industry.
We comply i.e., to GAMP5 and the requirements of the FDA with MDSAP and QSIT considering the specific standards as well as the regulatories and directives of the EU.
Our ecological footprintIT-Testing.de is an internet coaching and internet consulting engineering company. We are aware of our particular responsibility for a clean environment. Therefore, at the end of the business year, we donate a part of our profit to projects and organizations to support tree planting.
I am coaching and consulting freelancers, entrepreneurs and desider of small and mid-sized companies on the areas software testing, test management, QA and CSV as well as audits according to GAMP5, ISO 13485 and ISO 14971.
computerized system validation qualification QA quality assurance good practices guidelines medical device invitro diagnostics directive test management system development life cycle software testing MOCK audit inspection regulated regulatory authorized notified bodies IT infrastructure application supplier service provider sustainability ecological footprint