Kvalificering og Validering
Project Support A/S kvalificerer udstyr og procesanlæg i alle faser ved udarbejdelse af protokoller og testplaner i
henhold til ISPE baseline Pharmaceutical Guide Series og GAMP ”Validation of Automated systems”.
Project Support’s medarbejdere er trænede og kan enten kvalificere iht. kundes kvalitetssystem eller vha. Project
Vores kompetencer er bla.:
- User requirements specifications
- Kravsklassificering (Q eller C)
- Risk assessment process/komponenter
- Installation qualification (IQ)
- Operation qualification (OQ)
- Process qualification (PQ)
- SIP/CIP systemer
- Utility systemer
- Stand alone udstyr, fx:
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