SAFE Touts New Big Pharma Members, Promises More

July 18, 2006

Johnson & Johnson (J&J) and Cybertrust were the first organizations to be cross-certified with the SAFE Bridge Certificate Authority earlier this year, and SAFE-BioPharma Association President Mollie Shields-Uehling tells PIR two more “biggish” pharmaceutical players will join them by the end of this month.

SAFE-BioPharma is the nonprofit association that created and manages the Signatures and Authentication for Everyone (SAFE) digital identity and esignature standard for the pharmaceutical and healthcare industries.

Implemented properly, the standard will save companies time and money, Shields-Uehling said. Example: Submitting an Investigator Statement (Form 1572) signed with SAFE digital signatures can save a company $159 each time. Individually that may not sound like a lot, but given that almost 240,000 of those are currently submitted to the agency on paper per year, the savings could add up fast, she noted.

Working Closely With the FDA

The SAFE standard is designed to provide a secure, enforceable and compliant way to verify the identities of parties engaged in business-to-business and business-to-regulatory etransactions. It is also Part 11 compliant.

Founding members include AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck and Pfizer.

But even nonmembers are seeing “proof of concept,” Shields-Uehling said June 21. Her organization is doing consulting work with some of those companies to help them implement and leverage SAFE, she said. It has also developed a package of pre-production credentials, a signing interface and implementation guidelines to help member companies conduct pilot projects rapidly and efficiently.

SAFE-BioPharma has been working closely with the FDA, and Shields-Uehling applauded the agency for its help and interest in advancing SAFE. The SAFE team is conducting a training session for FDA inspectors this month, she added.

Additionally, FDA staff and the SAFE Compliance Working Group jointly developed the SAFE Digital Signature Inspection Techniques Guide earlier this year. It is the first approved working aid for “ensuring that member applications and processes comply with Part 11,” SAFE said in a statement.

FDA staff participating in the guide’s development included representatives of the agency’s chief information officer, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, as well as the Part 11 Council.

Vendor Partners

J&J and Cybertrust each completed an extensive process to demonstrate compliance with the SAFE standard and to assure interoperability and dependability for SAFE members, Shields-Uehling said.

J&J now provides SAFE-compliant digital identity credentials for use in SAFE authentication and SAFE digital signature services for 74,000 employees in various locations.

On the vendor front, Cybertrust is now offering SAFE to its customers who are members of SAFE BioPharma. More than 50 additional vendors are considering joining, Shields-Uehling said. Additional current vendor partners include: Adobe Systems, BearingPoint, IBD and OpenText.

SAFE has also just rolled out a discounted “association membership” option for members who join this year and intend to implement SAFE projects.

For more information, go to www.safe-biopharma.org or contact Ash Evans at Ashley.evans@safe-biopharma.org.