Our expertise in qualification has led to a proven and comprehensive approach. Some key aspects of our approach include:

• A thoroughly executed risk analysis to ensure that all aspects are considered and that the qualification work is effective and efficient
• The involvement of persons from different disciplines in the risk analysis
• Qualification activities planned in close coordination with all engineering disciplines

Our qualification services include:

• Validation Master Plans (VMPs)
• Risk analyses
• Qualification plans for all project phases:
• Design Qualification (DQ), Installation Qualification (IQ),  Operational Qualification (OQ), Performance Qualification (PQ)
• Supplier audits
• Execution of qualification plans
• Preparation of qualification reports
• Preparation of GMP documentation
• Re-qualification
• Establishing change control processes within the framework of a project
• GMP conform calibration
• Cleanroom testing