Blog Flex Databases

All the guidelines mentioned say that the approach toward computerized systems used in clinical practice (e.g., regarding validation) should be risk proportionate.

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++.