Computer System Validation for Pharmaceutical, Medical Device Manifacturer, Life Science, Biomedical, Biotech, Contract Reseach Organization (CRO), Research Centre, Cosmetic, Food Company, Software Vendor, Software House - GxP Software Validation GLP, GMP, GCP, GDP, ISO, SOX, FDA, EMA - Life Sciences Consulting - Life Cyle Management - FDA 21 CFR Part 11, European Medicines Agency Eudralex Annex 11, GAMP 5

Studio di Ingegneria Andrea Giampellegrini

Qualification & Certification Services of Industrial Processes and Computerized Systems

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)


  • 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

Versione Italiano

Versione in Italiano

CONTACT US for a Gap Assessment of your processes

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

EU-GMP Annex 11
For more information

Sistema Documentale di Convalida dei sistemi computerizzati :

Sistema documentale necessario per la conformità alla regolamentazione richiesta

Computer Validation Procedure
For more information

Procedura di Convalida dei sistemi computerizzati :

la procedura di convalida dei sistemi computerizzati definisce la metodologia di processo implementata

Computer Validation Procedure
For more information
Computer Validation
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