INSPECTION PROCEDURE 2023 revision
Annex III — Computer Systems
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.
EMBEDDED PDF
PDF NOT YET CACHED
This document hasn't been cached locally yet. View it directly on EMA's site.
OPEN ON EMA↗METADATA
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 ↗ RELATED · SAME AUTHORITY