Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4
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| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.2.3 |
| Scope | G |
| Document part | III. Annex 1
4.3.4 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Systems validation, Responsibilities, Risk, Device system |
| Comment | Validation responsibilities for computerised systems |
Content
4.3.4 Validation (a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validation of computerised systems should be based on a risk assessment that considers the intended use of the system; the purpose and importance of the data/record that are collected/generated, maintained and retained in the system; and the potential of the system to affect the well-being, rights and safety of trial participants and the reliability of trial results. […] (c) Systems should be appropriately validated prior to use. Subsequent changes to the system should be validated based on risk and should consider both previously collected and new data in line with change control procedures. […] (i) Unresolved issues, if any, should be justified and, where relevant, the risks identified from such issues should be addressed by mitigation strategies prior to and/or during the continued use of the system.
