EMA · Life Science & Pharma: GxP - CSV & Data Integrity
Notice to sponsors on validation and qualification of computerised systems used in clinical trials
Final CSV · Guidance Last verified: not yet · Source last checked 3 Nov 2026
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A reminder from EMA that clinical trial sponsors must be able to show their computerised systems are validated, even when vendors supply them.
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Lifecycle
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- First published
- Revision 1: administrative update of references
In plain English
EMA notice to clinical trial sponsors on validating and qualifying computerised systems, such as electronic case report forms and patient reported outcome tools.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
First published on 7 April 2020, this EMA notice reminds sponsors of expectations on validating and qualifying computerised systems in trials. Revision 1, dated 29 October 2026, only updates references, and EMA says it does not alter requirements.
EMA explains why it issued the notice: recurrent inspection findings affected the integrity, reliability and acceptability of data in marketing authorisation applications. The notice stresses that even if a sponsor delegates work, ultimate responsibility stays with the sponsor under Regulation (EU) No 536/2014.
Who and what it applies to
Clinical trial sponsors, and vendors providing computerised systems or services, for tools such as eCRFs, ePROs, safety databases, interactive response technology and clinical trial management systems.
What it contains
- Legal background
- Refers to Regulation (EU) No 536/2014 and ICH E6(R3).
- Expectations
- Validation evidence and sponsor responsibility, where vendors supply systems or services.
Key points
- The sponsor keeps ultimate responsibility, even when work is delegated.
- Sponsors must be able to show systems are qualified and validated, including vendor evidence.
- It was prompted by recurrent inspection findings.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Make sure you can access vendor validation documentation, and that contracts allow this during an inspection.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 29 Oct 2026 | Revision 1: administrative update of references | Final | Source for Revision 1: administrative update of references |
| 7 Apr 2020 | First published | Final | Source for First published |
Related
How other documents connect to this one. Links explained
- Complements EMA CS clinical trials· Compare with EMA CS clinical trials Unverified link
- Related to ICH E6(R3) GCP· Compare with ICH E6(R3) GCP Unverified link
Official source
The official text always prevails over anything on this site.
Source: EMA. Summary adapted from the original.
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