Quality Systems

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