Industry E-Signature Standard
This article was originally published in SRA
Executive Summary
Global SAFE project aims to speed document flow
Global SAFE project aims to speed document flow
A new international e-signature standard has been designed by a collaboration of biopharmaceutical companies, in cooperation with regulators and industry associations1. The Secure Access for Everyone (SAFE) initiative is intended to deliver unique global digital identity credentials, to address the growing challenge of companies, partners and regulators securely sharing complex regulatory documents.
In the past, every biopharmaceutical company has developed its own trust infrastructures2. Where these models have been extended to include external partner collaboration - without industry-wide standards for document signing and exchange - there has been no way to make document security and integrity absolute. In an industry that seeks to reduce the costs of drug development, this approach is not considered economically feasible.
Twelve major biopharmaceutical companies, including GlaxoSmithKline, Eli Lilly and Pfizer, have developed the Baseline Version 1 of SAFE in cooperation with the US Food and Drug Administration, the European Medicines Agency (EMEA), the European Federation of Pharmaceutical Manufacturers Associations (Efpia) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Similar to the FDA/PhRMA joint collaboration on SAFE, Efpia and the EMEA will collaborate in the codevelopment of SAFE and contribute European industry requirements to the SAFE specifications.
Publication of version 1 provides a legal infrastructure, policies, guidelines and technical specifications, with the following top-level objectives:
- enhanced regulatory compliance;
- single credential for each biopharmaceutical user;
- manageable liability;
- adaptability for electronic collaboration; and
- ability to achieve broad industry utilisation (SAFE can be used for any supply chain transaction).
The initiative also proposes to reduce costs of the digital signature and e-identity infrastructure. A proof of concept using SAFE credentials has already been successfully completed and a European pilot is planned with joint support from Efpia and the EMEA.
References
1. PhRMA press release, 9 June 2004, www.phrma.org
2. SAFE objectives, SAFE website, www.safe-biopharma.org