Signature Authentication

Introduction:  The written signature as a validation tool has not kept up with the electronic age.  Written signatures are cumberson, difficult to verify, easy to forge or pre date, and inflexible for staff. 

The clinicians signature is a requirement of multiple accrediting bodies (most notably the Foundation for the Accreditation of Cellular Therapy), and is needed for internal and external written agreements, audits, validations, SOPs, orders and consents.  The handwritten signature is an inefficient use of time and with multiple items needed for signature can be extremely cumbersome.  The DM and QM staff must wait for the document to be reviewed, (either in the moment or leave the document with the clinician and keep checking back for completion).   The handwritten signature can be easily forged or pre-dated making its authenticity questionable. 

Due to these factors an electronic signature was implemented in our program using an Adobe digital signature program.  This change was reviewed with our legal department and accrediting bodies who determined this was an acceptable, and preferable, format.  The change was as simple as changing preferences electronically and was able to be communicated to staff through a mass email.  Next, the documents to be signed were converted to PDF file format.  Those files were then sent electronically to the signator/s.  The signator/s then reviewed the documents at their leisure and returned the document to the originator with the electronic signature applied.

The PDF format of the document ensures that the information contained has not been altered.  The electronic signature uses encryption technology to verify the signer's digital identity.  The signature consists of three components, each of which can be customized; the signature, signature details (e.g. an email address or business location), and a watermark.  Each signature includes the real time and date that the signature was applied making post or pre dating impossible. 

Example:

Conclusion: Workflow was dramatically improved with electronic submission, review, and return of all documents providing increased flexibility on the part of the staff. There is a new integrity and authenticity to the signatures due to a higher level of security thru the use of encryption and the use of a real time and date stamp.  Staff, auditors, and inspectors alike can be assured they are viewing the most current, authentic, version of any document by reviewing the signature stamp.