Services: • Program and Project Management, Quality Management, Compliance Management • Developing Site Extension and Site Closure strategies within global environment • Developing and implementing Quality Management Systems QMS • Computer System Validation Master Planning CSVMP, VMP, VP and Compliance Audits • Providing GxP Training Courses for IT Associates and Contractors • Root Cause Analysis and CAPA Management • Medical Device Qualification / Validation, EMC testing (IEC / CISPR), 21 CFR Part 820 • Medical Device System Test Management according EN-60601 • Risk Management Planning and Assessments; ICH Q9 • Planning and creation of 21 CFR Part 11 systems • IT Hardware Troubleshooting Application lnadscapes • Process modelling and analysis