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Computerized Systems Used in Clinical Investigations.pdf

Contains Nonbinding Recommendations Guidance for Industry Computerized Systems Used in Clinical Investigations Additional copies are available from: ...  Down

How Can Computerized Systems Be Used in Clinical.pdf

Overview. I. Examples and Users of Computerized Systems used in Clinical Investigations II. FDA Regulatory Requirements & Expectations III ...  Down

Guidance for Industry - Food and Drug Administration.pdf

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for ...   Down

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  • Guidance for Industry - Food and Drug Administration

    Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for …

    www.fda.gov/downloads/ICECI/EnforcementActions/Bioresearch...
  • GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN …

    protect GxP systems whilst permitting authorised users to control the personal ... Validation of Computerized Analytical Systems, Interpharm Press, L. Huber,

    www.picscheme.org/...011-3-recommendation-on-computerised-systems.pdf
  • Annex 11 Final 0910 - European Commission

    Annex 11: Computerised Systems ... This annex applies to all forms of computerised systems used as part of a GMP regulated activities.

    ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf
  • ANNEX 11 COMPUTERISED SYSTEMS - European …

    112 Annex 11 Computerised systems _____ 6. The system should include, where appropriate, built-in checks of the correct entry and

    ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx11_en.pdf