As a member of the association, Astellas is able to utilize the SAFE-BioPharma standard throughout its operations. It is the first Japanese pharmaceutical company to become a SAFE-BioPharma member.
Digital identity credentials compliant with the SAFE-BioPharma standard are used to manage cyber-identities in the biopharmaceutical and healthcare sectors and to apply a higher form of electronic signature to electronic documents.
SAFE-BioPharma identity credentials will be used in several ways across the organization including application of digital signatures to submission documents for FDA and EU regulatory agencies and on a full range of clinical documents. Astellas also will use SAFE-BioPharma identity credentials for a variety of processes such as certifying scanned documents associated with case processing, computerized system validation for IT systems, and for change management procedures.
In addition to Astellas, SAFE-BioPharma pharmaceutical members include Abbott, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Merck, Pfizer, Roche and Sanofi.
“We welcome Astellas to the expanding community of organizations using the SAFE-BioPharma standard. Their use of the standard will help improve productivity, cost reduction, and time to market by moving their processes more completely online,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.
In 2012, Astellas Pharma was a winner of the SAFE-BioPharma “Digi” Award in global expansion for its innovative use of SAFE-BioPharma digital signatures in a virtual clinical process pilot project in Japan.
The SAFE-BioPharma standard was created by the biopharmaceutical industry to provide standardized, high-assurance identity trust for cyber-transactions. The US CIO Council, the FDA and the EU EMA participate in the standard’s ongoing development. Among its rules and regulations, the standard requires a close bond between the user’s cyber-identity and actual identity. Digital signatures based on the standard are more secure and legally binding than conventional electronic signatures and are recognized by regulatory agencies throughout the U.S. and Europe.
The identity resides in a computer, token, or, increasingly, in a highly-secure hardware module in the cloud and, in addition to applying signatures, is used for authorized access to information stored behind company gateways, portals and firewalls.