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.
The primary flaw in this process is that it is based on a small sampling of the signature database, and that it relies strongly
on the signatories' willingness to respond accurately to the confirmation letter. Unfortunately, because physicians now receive
a barrage of these confirmation letters from pharmaceutical vendors, the quality of the response rates and resulting accuracy
have diminished.
Sam Barclay
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Technology has evolved to enable signatures, both electronic and on paper, to be digitally compared against previous signatures
from the same author, and then rated on a scale of confidence for authenticity.
For authentication, a signature is an image. With sophisticated pattern recognition technology, the signature image is converted
into digital code. The images are then compared mathematically in hundreds of ways, and the outcome is a confidence score.
Equally effective in paper and electronic signatures, the confidence score indicates the likelihood that a given signature
instance is a forgery or an authentic. To improve the accuracy of the process, several previously captured signatures can
be used to create a reference signature, which is in effect an average of a group of signatures.
Any signatures highlighted as suspicious can then be sent for personal review or can be used to create confirmation letters
to physicians. Because only suspicious signatures are sent to doctors, fewer letters are generated, and they will be targeted
to only those doctors who must respond.
The benefits of electronic signature capture, as well as the ability to store and report on electronic records, are enormous.
Some organizations have been reluctant to move off paper-based signatures until the risk of signature fraud can be properly
mitigated through technology. Today, advances in e-signature authentication feature accurate character recognition, noise-filtering
algorithms, and extraction of key data with extreme accuracy. New technology can also recognize all types of characters, such
as machine print, handprint, alphanumeric sequences, international characters, and gray-scale images.
Signature authentication technology improves the complexities of the signature authentication process, increases the confidence
in the outcomes and related business and compliance decisions, while enhancing customer experience.
Sam Barclay is vice-president of business development at StayinFront (Fairfield, NJ), tel. 973.461.4800, sbarclay@stayinfront.com
