Qualification & Validation
We can perform following services :
- Industrial Organisational Process Risk Analysis
- Industrial Process Risk Analysis
- cGMP Regulatory Audit
- User Requirement Specifications Redaction
- Validation Master Plan
- Qualification Master Plan
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Computer validation following GAMP 5, CFR21 part 11
- Process Validation
- Installation, Operational and Performance requalification