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INSPECTION PROCEDURE 2023 revision

Annex III — Computer Systems

EMA/INS/GCP/155774/2022 European Medicines Agency
ABSTRACT — EDITORS' SUMMARY

What EMA inspectors check on computerised systems at all inspected entities. Companion to the 2023 Computerised Systems guideline — this is the inspection checklist.

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METADATA
TypeINSPECTION PROCEDURE
Year2023
Version2023 revision
StatusCurrent
FormatPDF
Pages—
Size180 KB
Last reviewedSEP 2023
SOURCE
PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iii-procedure-conducting-good-clinical-practice-inspections-requested-ema-computer-systems_en.pdf ↗
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