Glossary:TAG-00113-Aud-tQu

Glossary > Audit

Audit
Tag-ID	TAG-00113-Aud-tQu
English	Audit / GCP audit / Quality audit
French	Vérification / Audit / Audit qualité
German	Audit / GCP-Audit / Qualitätsaudit

References

	Scope	Document part	Language	Document
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001	MD	Article 109 Paragraph 1	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit	G	GLOSSARY - Audit	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2	G	III. Annex 1 3.11.2	EN	ICH ICH E6 Guideline R3 (2025)
IMDRF IMDRF – Guidelines - -	MD	-	EN	IMDRF IMDRF – Guidelines -
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11	MD	7.11	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J	MD	Annex J	EN	ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001	HM	4.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002	HM	4.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003	HM	4.12	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial	HM	Glossary - audit of a trial	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995