Glossary:TAG-00064-Ele-eUn

Glossary > Electronic records

Electronic records
Tag-ID	TAG-00064-Ele-eUn
English	Electronic documentation / Electronic records / Electronic trial documentation
French	Documentation électronique / Enregistrements électroniques / Documents électroniques
German	Elektronische Dokumentation / Elektronische Unterlagen / Elektronische Studienunterlagen

References

	Scope	Document part	Language	Document
EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14	G	14	EN	EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011
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 § 11.3 (b) (6)	G	§ 11.3 (b) (6)	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
USA 21 CFR Part 11 09-Apr-2025 § 11.50	G	§ 11.50	EN	USA 21 CFR Part 11 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m)	G	§ 46.102 (m)	EN	USA 45 CFR Part 46 09-Apr-2025
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV	G	IV	EN	USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III	G	III	EN	USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2.	G	III 2.	EN	USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.	G	III 4.	EN	USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling	HM	8 - Electronic data handling	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995