What is a key requirement for the digital signature on an e-script?

The requirement that the digital signature on an e-script must follow the standards set by 21 CFR 1311 is significant because this regulation outlines the administrative and technical requirements for electronic signatures used in applications regulated by the FDA. By adhering to these standards, the integrity, authenticity, and non-repudiation of the e-prescription are maintained, ensuring it is securely and legally valid. This promotes confidence in the electronic prescribing process, as it establishes that the electronic signature meets the necessary regulatory criteria designed to protect patient safety and uphold the law.

While other options may address aspects of electronic prescriptions, they do not align with the legal framework that governs the validity and reliability of digital signatures in e-scripts. For instance, limits on file size or requirements for manual entry do not fulfill the overarching legal obligations that ensure an electronic signature's compliance and security as mandated by federal law.