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Pharma (GxP)

Process

  • System Analisys (PQLI)
  • Process Flow Analisys
  • Risk Analisys (GxP/Business)
  • Nonconformities structured review and analysis
  • Validation Documents wrap up (VP, Protocols, System Description)
  • Standard Operating Procedures wrap up
  • Test Execution / Supervision
  • Audit
  • Remediation/Action Plans
  • Business Continuity (BS25999)

Validation

  • System and Application Software
  • Control and Management Systems in pharmaceutical environment (DCS, SCADA, PLC, PID, instrumentation etc.)
  • IT Site Infrastructure Network
  • Systems/Equipment in Production environment
  • Systems/Equipment in Packaging environment
  • Systems/Equipment in Laboratory environment
  • Building, Utilities e Ancillary
    • HVAC
    • Wharehouse logistic systems
    • Production ancillary systems
    • Water Treatment
  • Computerized Systems for analitical Laboratory equipment Management & Control
  • Computerized Systems for Clinical Data Management

Technical Qualification

  • Commissioning (ISPE vol. 5 march 2001)
  • FAT (Factory Acceptance Test)
  • SAT (Site Acceptance Test)
  • Critical Instrumentation Calibration

Training

  • Basic Training & Tailored Courses

Significant work