By John Russell
July 14, 2008 | On September 18, 2006, AstraZeneca U.S. Regulatory Affairs submitted the first electronic original 356h form (Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use) to the FDA. By using SAFE signatures and the FDA Electronic Submissions Gateway (ESG), AstraZeneca completed a landmark milestone and earned an IT and Informatics Best Practices award. (see Best Practices) No paper original of the 356h exists.
Playing it safe isn’t generally thought of as leadership but in this instance, AstraZeneca led the industry with its effort to start taming paper-ridden processes that invite error, add cost, and slow down industry and FDA efforts to deliver safe, effective drugs.
The 2006 submission was the successful culmination of joint project by AstraZeneca U.S. Regulatory Affairs and AstraZeneca IT staffs to implement FDA’s Electronic Submissions Gateway (ESG) digital signature based on the Signatures and Authentication for Everyone standard.
AstraZeneca is a founder member of the SAFE-BioPharma Association working to streamline secure communications within the industry. Joe Waldron, executive director, U.S. Region, global drug development information services for AstraZeneca, says “Anywhere we do wet ink signatures today is a place where we can be leveraging SAFE digital signatures tomorrow, and begin to reduce the burden associated with managing paper.”
As is often the case the ESG project (AZ regulatory group) and SAFE project (AZ IT group) began as independent efforts. In May 2006, the two efforts were joined in order to have a completely electronic submission; eliminate the overhead activities to create, sign, store, and maintain paper originals; and provide faster availability to clinical data. In doing so, AstraZeneca gained flexibility as employees could apply SAFE digital signatures to documents from anywhere with an Internet connection.
The teams faced a tight time schedule, starting in April 2006 with a delivery date in early fall. Business challenges included developing operating procedures, managing credential ownership, defining system ownership, and ensuring organizational buy-in. Technical challenges included enabling an application, selecting a credential issuer, performing internal validation, planning for support, and delivering credentials to users.
The result was a Windows 2000 client implementation of SAFE digital signatures which used the following: Adobe Acrobat Professional; ARCOT Systems’ SAFE digital signature plugin for Acrobat; and SafeNet secure USB tokens. Additionally, a process was developed to register AstraZeneca employees for SAFE tokens that minimized the amount of time required to complete the registration process.
The teams identified some of the key elements of project success as business leaders as champions for the project; department-level scope for SOPs, training, and support activities; limited number of users (80) to be provided with SAFE credentials and training; delivery focused on SAFE signatures, not on company-wide identity management; and leveraging experiences, tools, and templates from SAFE, other members, and consultants. All of these elements combined for a successful on-time and on-budget delivery.
“Utilization of the FDA ESG, along with SAFE Digital Signatures, provides a critical link in enabling AstraZeneca to transition to a fully electronic environment,” says Tony Rogers, VP, U.S. regulatory affairs.
Success is now driving expansion of the program. “Due to the enthusiastic response from users signing regulatory documents, we are looking for opportunities to leverage the existing solution for digitally signing documents in other areas,” says Rich Ware, one of the project team leaders. “By the end of this year we expect to have employees within Clinical Development signing documents with SAFE credentials, in addition to those in Regulatory Affairs.”
This article appeared in Bio-IT World Magazine.
Subscriptions are free for qualifying individuals. Apply Today.