Computerised System Validation

Andreas Kühnel

• Validation of computerised systems
• Planning and implementation of the essential inrastructure
• Network qualification
• Writing of SOPs in compliance with GMP and GCP
• Business Continuity Mangement
• more...

GCP QC Services

Andrea Plum

• 25 years experience in Clinical Research
• Drug and Device Trials
• Clinical monitoring in Europe, phase I – III for sponsors in Europe and US
• On-site monitoring oversight visits in Europe for sponsors in Europe and US
• Sponsor Oversight Programs
• Trial Master File Reviews
• Audit and Inspection Readiness Assessments
• more...