Article: From Go-Karts to Formula 1: Distinguishing True Digital Signatures particularly for the electronic submission of critical regulatory documents

Digital signatures have become an essential part of doing business in the drug industry, particularly for the electronic submission of critical regulatory documents. And yet many in the industry still do not know what constitutes a safe and compliant digital signature, much less know what separates digital signatures from “electronic” signatures, says Mollie Shields-Uehling, president and CEO of the standard-setting SAFE-BioPharma Association.

The SAFE-BioPharma standard is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents, Shields-Uehling says. The standard was developed by a non-profit consortium of biopharmaceutical and related companies, with participation from the FDA and EMA. “The SAFE-BioPharma digital signature offers a greater level of protection than other forms of electronic signature,” she adds. “It provides authentication, non-repudiation and data integrity across every single bit of the information to which the signature is applied. In simple terms, this means that if any component of the signed document is ever changed, the signature will be invalidated.

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