Pharma – Medical Device – BioTec
„Where IT-Compliance
meets Experience“
Compliance & Strategy
- Validation Strategy
- Validation Planing
- Validation Management
- Validation Methods and Engineering
- Compliance Management
- Compliance (Project-) Coaching
- Coordination of Projects/ Direction of Validation
- IT-QA
Compliance & IT-Projects
- CSV Projects
- Software Systems
- Hardware Systems
- CSV for Pharmaceutical Facilities
- GAMP Periodic Review
- System-Migration/ GMP
- System Replacement under GMP
- Storage-/ MFR-Systems
IT-Validation (CSV)
- GAP Analysis
- GAMP-5 Conformity
- Data Integrity – Compliance
- (GMP-) Data Migration
- Hardware- and Data Processing Qualification
- ERP System-Validation
- SOP and Procedure Specifications
- System CSV
Requirements & Processes
- URS – User Requirement Specifications
- GMP – Prozess Design & Optimising
- Process Platforms for ERP-Systems
- Concepts for Laboratory Systems
Audits & Inspections
- Compliance Status-Analysis
- Preperation for Inspections
- Monitoring of Inspections
- Vendor Audit
- Selftinspection
- CAPA Management
- Follow-Up Services
according to the guidelines of
© Copyright: AvexorTec® Pharma Consulting Munich