As technology transforms healthcare, regulatory authorities worldwide are urgently crafting modern frameworks to govern electronic systems in drug trials. While these innovative systems show promise, their infancy introduces variables that can impact trial outcomes. European regulators, at the forefront of embracing innovation, have established guidelines prioritizing data accuracy and patient well-being. The European Medicines Agency's groundbreaking guideline, effective from September 2023, sets a standardized framework extending oversight to healthcare facilities. This comprehensive approach mandates a stringent validation process for electronic tools, ensuring accuracy, reliability, and compliance. The article explores the evolution of regulatory frameworks, challenges posed by electronic systems, European initiatives, and the impact of the EMA guideline on ensuring data integrity in clinical trials.