Glossary:TAG-00127-Com-meC

Glossary > Systems validation

Systems validation
Tag-ID	TAG-00127-Com-meC
English	Computerised systems validation / Computer system validation
EN Abbr.	CSV
French	Validation des systèmes informatisés / Validation informatique / Validation des systèmes informatiques
FR Abbr.	VSI
German	Validierung computergestützter Systeme / Computervalidierung / Systemvalidierung
DE Abbr.	CSV

References

	Scope	Document part	Language	Document
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2	G	4.2	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6	G	4.6	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13	G	A4.13	EN	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 System Security	G	System Security	EN	GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation	G	GLOSSARY - Computerised Systems Validation	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10	G	III. Annex 1 2.12.10	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution	G	III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3	G	III. Annex 1 4.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3	G	III. Annex 1 4.3.3	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4	G	III. Annex 1 4.3.4	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8	G	III. Annex 1 4.3.8	EN	ICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 11 09-Apr-2025 § 11.10	G	§ 11.10	EN	USA 21 CFR Part 11 09-Apr-2025
USA 21 CFR Part 11 09-Apr-2025 § 11.30	G	§ 11.30	EN	USA 21 CFR Part 11 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation	HM	Glossary - validation	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995