Instead of collecting pen-and-ink signatures, life science organizations are looking to digital signatures to reduce the time, expense, and data inaccuracies that come from scanning and rekeying information.
The SAFE-BioPharma Association has developed a unified business, policy, and technical
model that defines digital signatures for the life science industry.
This cross-organizational standard reduces the time to market and cost of clinical trials by streamlining the way regulatory agencies, pharmaceutical companies, clinical research organizations manage and verify digital signatures.
SAFE has excellent support from many pharmaceutical companies and industry associations who already support the standard.
Adobe Acrobat and Reader 8 have been certified to comply with the SAFE standard.
However, before employing SAFE in Acrobat, some set-up and configuration is necessary.
My colleague Ed Chase has been actively involved in Adobe’s support of SAFE and has written a guide to simplify using and deploying SAFE signatures.
Following, you’ll find the guide which describes how to set up Adobe Acrobat and Adobe Reader to best support the technical and user interface requirements of the SAFE standard.
Download the Adobe Acrobat & Reader SAFE Configuration Guide
Adobe Acrobat & Reader SAFE Configuration Guide (833K, opens in a new window)
Note: The document above is an Acrobat 7 file with embedded attachments. The attachments include:
- SAFE plug-in for Acrobat
- SAFE signature appearance
- End User License Agreement
Notes about the Guide
The document can be used by individuals who wish to enable SAFE signature support for Acrobat on their own computers, or may also be used by system administrators who are preparing Acrobat or Reader for enterprise deployment within their organizations.
This guide is not a substitute for the SAFE technical specifications, but is intended as an Acrobat and Adobe Reader-specific supplement to those specifications. There are many factors, both technical and procedural, that are outside the scope of this document, that must be considered to successfully implement SAFE-enabled applications and processes. Please refer to the SAFE specifications and certificate policies for more information available at from the SAFE-BioPharma Association.
Basic Steps covered in the Guide
In order to configure SAFE Signatures, you will need to do the following:
- Obtain and Install a SAFE Digital ID
- Employ a method to establish trust in Acrobat
- Configure signature appearance
- Set signature preference
- Optional: Install the SAFE plug-in which provides an easy-to-use toolbar for signature creation
Reader Enabled PDFs for Digital Signatures
Both Adobe Acrobat Standard and Professional can create signature fields and sign documents.
Adobe Reader users can only sign PDF documents which have specifically been Reader enabled by one of the following products:
- Adobe Acrobat Professional
Enable a single PDF at a time, subject to the limitation of the End User License Agreement (EULA)
- Adobe LiveCycle Reader Extensions ES
An enterprise-class server product which may be integrated in workflows.
Reader Extension Limitations for Adobe Acrobat Professional
Large pharmaceutical companies may run into restrictions specified in the Acrobat Professional End User License Agreement (3.8M PDF, opens in new window) for extending documents:
For any unique Extended Document, you may only either (a) Deploy such Extended Document to an unlimited number of unique recipients but shall not extract information from more than five hundred (500) unique instances of such Extended Document or any hardcopy representation of such Extended Document containing filled form fields; or (b) Deploy such Extended Document to no more than five hundred (500) unique recipients without limits on the number of times you may extract information from such Extended Document returned to you filled-in by such Recipients. Notwithstanding anything herein to the contrary, obtaining additional licenses to use Acrobat Professional shall not increase the foregoing limits (that is, the foregoing limits are the aggregate total limits regardless of how many additional licenses to use Acrobat Professional you may have obtained).