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• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 3-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 3 – 4-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Paragraph 3 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-001 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 57 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 56 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.6 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4. by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 45 CFR Part 160 09-Apr-2025 - by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.30 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3 6 by file upload (1 revision)
• 13:50, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note by file upload (1 revision)