INSPECTION PROCEDURE 2022 revision
Annex VI — Record Keeping and Archiving of Documents
ABSTRACT — EDITORS' SUMMARY
What EMA inspectors check on TMF completeness, record retention, and archiving arrangements. Companion to E6(R3) Appendix C Essential Records.
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PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-vi-procedure-conducting-gcp-inspections-requested-chmp-record-keeping-and-archiving-documents_en.pdf ↗ RELATED · SAME AUTHORITY