Signature Authentication Can Restore Confidence

Whether to thwart illicit activities or improve compliance reporting, pharmaceutical sales operations must have confidence in the paper-based and electronic signatures they gather from physicians while in the field. The need to manage signature capture, especially in the pharmaceutical industry, is not a new challenge. FDA 21 CFR Part 11 guides the industry on this topic, as it relates to electronic signature capture. Since confirming orders or authorizing receipt of drug samples necessitates a physician's signature, the ability to authenticate a signature is the key variable in these compliance-centric processes.

Some organizations rely on paper-based signatures instead of e-signatures. In both cases, pharmaceutical companies must have the processes in place that confidently ensure that the captured signatures are genuine, are being obtained in the correct manner, and for the correct purpose. Previously, this "confidence" was based on a small random sampling of signatures that were printed and mailed to the signatories with a request that they confirm the printed signature as their own.

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