We consult and consult our clients online and with our training portal.
Our experienced consultants and coaches support you individual according to your needs as:
- GxP Specialist
- CSVapt® Consultant
- Projekt manager
- Team lead
- Team member
- Interim director
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 instruct suppliers and service providers and show them which requirements they have to fulfill in a regulated industry.
We comply to GAMP® 5 - 2. Edition 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 companies on the areas CSV, GxP, Compliance, QA, software testing, test management and verification of medical devices as well as audits according to GAMP® 5 - 2. Edition, ISO 13485 and ISO 14971.
computerized system validation apt adapted precise trailormade 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