The process of ensuring and documenting that an electronic data processing system conforms to the...

Validation is the process of ensuring that an electronic data processing system meets the sponsor's specifications for completeness, accuracy, reliability, and consistent performance. It involves systematic testing and documentation to demonstrate that the system functions as intended, especially in the context of capturing, processing, and managing clinical trial data.

GCP guidelines specify that validation of electronic systems is crucial to maintain data integrity and compliance with regulatory standards.

"Validation ensures that electronic data systems function according to the sponsor's requirements, maintaining data accuracy and reliability."

Objectives:

Maintain data integrity and reliability.

Demonstrate system compliance with regulatory requirements.