Abstract

This document describes an eSignature extension for Daisy. It requires (at least) Daisy version 2.1.

eSignature?

Reference: pages 36-38 of http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf

For certain applications (life sciences), users are required to sign that they have authored a certain document, using a so-called electronic signature. While an electronic signature might make use of digital signatures and encryption, for so-called closed systems this is not required. An electronic signature is equivalent to a handwritten signature: it is a means by which a person authenticates a certain writing with a certain intent (e.g. authored, read, reviewed, approved, ...). For closed systems (see the FDA document), Daisy already supports some of the important requirements:

• it authenticates users using login and passwords
• it keeps previous versions available, versions are timestamped and are linked to the modifier

One specific requirement that is not fulfilled by default is item 11.200, (a), (1), (i) : When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual

In Daisy-speak, this means that when a user saves a document in the editor, the user should re-enter the password. The esignature extension described here implements this behaviour.

Installing the extension

Get the extension from Daisy SVN:

svn export http://svn.cocoondev.org/repos/daisy/extras/esignatures/trunk esignatures

Copy the esignature subdirectory to

<wikidata dir>/sites/cocoon

So the result will be a new sub-directory in there:

<wikidata dir>/sites/cocoon/esignature

Now create the following file

<wikidata dir>/conf/documenteditor.xml

and put this in it:

<?xml version="1.0" encoding="UTF-8"?>
<configuration>
  <preSaveInteraction>ext/esignature/sign</preSaveInteraction>
</configuration>

And that's all. When you now edit and save a document, you should be passed via the screen asking you to sign using your password.

It can take up to 10 seconds for configuration changes to be noticed by the Daisy Wiki.

Implementation background

[TODO: link to document describing the pre-save-interaction mechanism]

Fields