EMA Guideline on computerized systems and electronic data in clinical trials
Validated Cloud operations and validation practices are in alignment with the European Medicines Agency’s (EMA) Guideline on computerized systems and electronic data in clinical trials. Re: EMA/INS/GCP/112288/2023 Good Clinical Practice Inspectors Working Group (GCP IWG) and https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf This guideline is a very prescriptive approach to compliance and the expectations of service providers, data handling and [...]