Computer System Validation in Pharmaceuticals
In addition to our outstanding credentials, Aphena has many management systems in place to ensure quality during the production of every product.
- Full Validation Program
- Master Validation Plan
- Equipment IQ, OQ, PQ
- Process
- Cleaning
- Facilities / Environment
- Laboratory
- Enterprise Quality Management Software System
- Laboratory Information Management System
- Workflow Control: Receiving, Production & Shipping
- Master Batch Services Record Development & Documentation
- Rigorous Management of Change Control
- CAPA Program (Corrective And Preventive Action)
- Detailed Standard Operating Procedures Training Program
- Robust In-Process Testing & Verification Systems