Astellas Pharma has joined the SAFE-BioPharma Association, a nonprofit industry coalition responsible for the ongoing development and implementation of the global SAFE-BioPharma digital identity and signature standard. As a member, Astellas is able to utilize the SAFE-BioPharma standard. It is the first Japanese pharmaceutical company to become a 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 certifying scanned documents associated with case processing, computerized system validation for IT systems and change management procedures.
“Their use of the standard will helpimprove productivity, cost reduction and time to market by moving their processes more completely online,” said Mollie Shields-Uehling, president and chief executive officer, SAFE–BioPharma Association.
The SAFE-BioPharma standard was created to provide standardized, high-assurance identity trust for cyber-transactions. The U.S. 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 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.