Pharmaceutical Companies have to comply with 21 CFR part 11, Electronic Record and Signature regulation, and Microsoft SharePoint has not a fully compliant electronic signature. Regulation states that "electronic signature" can also be a combination of two elements, UserID and Password, but these should be entered when the signature is required to confirm or approve a record or an associated document: the logged in user is not sufficient, the credential should be required by the system exactly when your approval signature is required, and the timestamp should be stored and maintained for the retention period, linked to the signed item: unfortunately the out of the box signature features available in SharePoint 2007 or 2010 are merely based on the login credential, and the confirmation of the same credential is not required when you execute a standard approval task!

K2C eSignature for Sharepoint is an add-on that easily allows you to add an electronic signature action to any workflow, fully compliant to part 21 CFR part 11 regulation. You can therefore electronically sign, with an equivalent legal value of a paper signature, any document or record that is subject to an approval workflow.

K2C eSignature for SharePoint is available both for SharePoint (Moss) 2007 and SharePoint 2010. After the installation, a new workflow action "eSignature" is available in SharePoint Designer, and you have simply to insert this action at the desired workflow step in order to collect the user signature without any custom development or coding knowledge.

You can use this action to sign both list items and document items, also indicating additional information about signer and the desired statement to be shown when the signature is required, in order to explain the meaning of the signature.

To receive a free trial version or pricing information, please contact us.