Electronic vs. Digital Signatures: The Compliance Factor

November 12, 2013 by

The pharmaceutical industry is evolving in regards to documentation, quality, efficiency and security. Automation is critical, therefore companies are rapidly moving to platforms that leverage paperless working environments in order to enhance quality, reduce costs and gain efficiency. A large component of automation is the ability to workflow documents electronically. This has sparked confusion and debate in regards to signatures, specifically electronic signatures versus digital signatures. These terms are widely misinterpreted and there isn’t clarity around how they impact compliance and regulations, such as 21 CFR Part 11. Compliance for any signature whether digital or electronic will always revolve around the key elements of information associated with the printed name of the signatory, along with the date, time , and reason for the signature. Here’s how we explain the two types of signatures to our customers. Digital Signatures An electronic signature based upon cryptographic methods of originator authentication, computed by using mathematical rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. What we are talking about here is using actual embedded tokens or components within documents that enforce validity checks. If anyone modifies the document from the signed state the token recognizes that the document state is altered and the digital signature is now “invalid”, thus promoting…

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