Computerised System Validation

Services

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

Regulatory Framework

• EU GMP Annex 11
• EU GMP Annex 15
• GAMP 5
• 21 CFR Part 11
• PIC/S Guidancw
• ITIL

Profile

Education

• Civil Engineer, Technical University of Aachen (RWTH Aachen)

Certificates

• ITIL Foundation Certificate in IT Service Management
• Certified Computerised Systems Validation Representative

Experience

• IT Project Manager within Life Science Industry for more than 15 years
• Database programming
• CSV
• Infrastructure and Network Qualification
• Business Continuity Planning
• Writing of SOPs
• Validation of a Pharmacovigilance Database
• Validation of a GMP Laboratory

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