Qualification & Validation
- Development of Qualification Protocols
- Standard Operating Procedures (SOPs)
- Factory Acceptance Test (FAT) & Site Acceptance Test (SAT)
- Quality Management System
- Validation Master Plan (VMP)
- Equipment Validation
- Equipment, Utility, and Facility Validation
- Computer System Validation
- PLC HMI and Automation Validation
- Risk & Impact Assessment
- Development of DQ , IQ , OQ and PQ Documents
- Review and Develop User Requirement Specification (URS)
- Review of Functional Design Specification (FDS) of equipment
- Qualification Schedule
