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Computerized Systems Used in Clinical Investigations.pdf

Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) ...  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 …

    SYSTEMS IN REGULATED “GXP” ENVIRONMENTS ... 4. Validation of Computerized Analytical Systems, Interpharm Press, L. Huber, ISBN: 0-935184-75-9, 1995 5.

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

    Annex 11: Computerised Systems Legal basis for publishing the detailed guidelines: ... systems, which makes it possible for the application to function.

    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