Good Operating Practice Consulting
Qualification & Certification Services of Processes, Systems, Equipments and Devices, in regulated environment:
- GLP, GMP, GCP, GDP (Food and Drug Administration, European Medicines Agency)
- European Commission Directives
- ISO (International Organization for Standardization)
- SOX (Sarbanes-Oxley Act)
- ASTM (American Society for Testing and Materials)
Industries:
- Pharmaceutical
- Medical Device Manufacturer
- Life Science
- Biomedical
- Biotech
- Contract Reseach Organization (CRO)
- Research Centre
- Cosmetic
- Food Company
- Software Vendor
- Software House
- Laboratory (Analysis, GMP, Testing, Calibration)
Roles involved:
CIO, IT Manager, Manufacturing Manager, Process Manager, Quality Assurance Responsible, Qualified Person, Quality Manager, Validation Engineer, R&D Manager, Regulatory Affairs Officer, Documentation Manager.
19 Jun 2017
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NEWS : Buone Pratiche di Fabbricazione Europee in ambito farmaceutico
La revisione dell’Annex 11: La Gestione dei Sistemi Computerizzati |
Revisione dell'Annex 11 entrato in vigore il 30 giugno 2011 |
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Sistema Documentale di Convalida dei sistemi computerizzati : |
Sistema documentale necessario per la conformità alla regolamentazione richiesta |
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Procedura di Convalida dei sistemi computerizzati : |
la procedura di convalida dei sistemi computerizzati definisce la metodologia di processo implementata |
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