Electronic and Digital Signatures

There is no standard definition for the terms "electronic signature" or "digital signature", but they typically relate to "closed system" and "open system" signatures on electronic documents.

An Electronic or Closed System signature is one that is contained in a system that controls an electronic document. It is used whenever all parties that need to confirm the validity of the document have access to the closed system that contains the document. It usually includes a controlled process for applying the electronic signature to ensure that the person identified in the system as the signer is the actual document signer. FileHold provides a workflow approval activity that can be used to satisfy the requirements for electronic signatures in a variety of compliance standards such as the FDA 21 CFR Part 11 standard for Electronic Records management.

A Digital or Open System signature is one that is inseparable from the electronic document. It is used when a document must transfer between two or more unrelated parties and or systems. The method and systems involved in the transfer, such as email, are difficult or impossible to be secured. This means the document itself must be secured. This is done by taking the original document and enclosing it in a digital signature "envelope".

When the digitally signed electronic document is opened with an application that can interpret the envelope, it is possible to confirm the validity of the contents of the digital signature and also confirm if the document has changed since the digital signature was applied. Any change, no matter how small, in the document will render the signature invalid and the reader will be notified. Digital signatures can be apply to many types of documents including PDF format documents. The standard free Adobe Reader can interpret these signatures and report on the authenticity of the document. A special application is needed to create the digital signature.

The closed and open system signatures methods described above provide the necessary technical solution for signatures on electronic documents, but this is not sufficient for any complete signature solution. For example, if a closed system solution let all users have the same user id and password this would not be suitable for signing documents. If there was no way to verify the signer in a digital signature, the signature would be useless.

Regardless if a closed or opened signature solution is used, there must be the appropriate controls on technical infrastructure, personnel, standard processes, etc. in order for the signatures to be valid. This is the equivalent of the possibility for a forensic expert to analyze the original signature of a signer on a paper document. FileHold offers a solution that uses a third party to provide the necessary system controls for digital signatures to make it easy for our customers' digital signatures to stand up to legal scrutiny.

There is an additional option for signatures on electronic documents that may add some familiarity with the pen-on-paper method. It is possible with certain document format and digital signature envelopes to include a stamped replica of a hand written signature. While this provides no real legal value it can be a helpful indicator that the document was signed. Signature stamps can be created in FileHold using the Brava viewer.