E-Signature Standard
This article was originally published in SRA
Executive Summary
Non-profit company will administer SAFE standard
Non-profit company will administer SAFE standard
A group of eight leading pharmaceutical companies have agreed to establish a not-for-profit limited liability company, SAFE-BioPharma LLC, to support the widespread adoption of the global digital identity standard1. The intention is for SAFE-BioPharma to establish and maintain standards and operating rules for the provision and management of digital credentials for use in the transfer of electronic clinical research records between biopharmaceutical companies and regulatory agencies worldwide. It was expected to be in operation by March 2005.
The eight companies are AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Pfizer, Procter & Gamble and Sanofi-Aventis. Other companies will be encouraged to join the organisation to ensure the widest possible adoption of the standard: Amgen has already agreed to become a member. A draft version was completed in June 2004, and has been further developed in collaboration with regulatory agencies and pharmaceutical industry associations in the US and Europe2.
In addition to managing the standard, SAFE-BioPharma says it will provide accreditation and certification programmes to ensure that SAFE-enabled applications and identity credentials are commercially available, establish best practices for the implementation and use of the standard, and ensure seamless interoperability of credentials issued by accredited SAFE issuers.
References
1. PhRMA press release, 9 February 2005, www.phrma.org
2. The Regulatory Affairs Journal - Pharma, August 2004, 15(8), 596