On March 20, 1997, FDA published a final rule on electronic records and signatures, which FDA will deem electronic records and electronic signatures equivalent to paper records and traditional...

On March 20, 1997, FDA published a final rule on electronic records and signatures, which FDA will deem electronic records and electronic signatures equivalent to paper records and traditional handwritten signatures if electronic signatures and associated electronic records meet the requirements of the regulation. In order to maintain the integrity of electronic records and signatures, describe the main requirement for the validation of both documents.