All the guidelines mentioned say that the approach toward computerized systems used in clinical practice (e.g., regarding validation) should be risk proportionate.
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Flex Databases compliance checklist for EMA Guideline on computerised systems and electronic data in clinical trials
Data integrity has always been a critical point during the development of eTMF systems. One of the industry’s latest standards is ALCOA++, and our eTMF module is 100% compliant with ALCOA++.