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• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4  +
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10  +
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution  +
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3  +
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3  +
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation  +
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4  +
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling  +
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2  +
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4  +
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA  +
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT  +
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6  +
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13  +
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6)  +
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10  +
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30  +
• Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m)  +
• Reference:USA 45 CFR Part 160 09-Apr-2025 -  +
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II  +
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.  +