GCP: A Question & Answer Reference Guide * Validation of computer systems used. including the following: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conductinggcp-inspections-requested-chmp-sponsor-and-contract-research-organisations-cro_en.pdf 240https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conducting-gcp-inspections-requested-chmp-sponsor-and-contract-research-organisations-cro_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conducting-gcp-inspections-requested-chmp-sponsor-and-contract-research-organisations-cro_en.pdf