With massive quantities of highly sensitive information making its way through a number of different companies, business units and regulatory agencies, biopharmaceutical companies need a very high bar for the digital identification of individuals and the verification of signatures.
Recently, the SAFE-BioPharma Association, an industry initiative launched in 2005 and sponsored by the Pharmaceutical Research and Manufacturers Association, announced that it has delivered digital identity and signature standards that have already been adopted by two companies.
Johnson & Johnson can now provide SAFE-compliant digital identity credentials for use in authentication and digital signature services across its companies.
Similarly, Cybertrusts customers who are members of SAFE-BioPharma Association can use the SAFE-compliant digital identity in a range of business-to-business and business-to-regulator transactions over the Internet.
"Johnson & Johnson understands the growing business need to exchange sensitive information over the Internet between many disparate entities and information systems," says Gary Secrest, director of Johnson & Johnson information security and chairman of the SAFE-BioPharma Association.
"We have cross certified with SAFE in order to take full advantage of a standards-based digital credential capability and to enhance our ability to move to more paperless business processes," Secrest said.
The signatures are designed to be legally binding and regulatory compliant, meeting 21 CFR Part 11 requirements for electronic signatures and signed electronic records.
The FDA accepts SAFE-enabled digital signatures for legally binding documents and regulatory submissions. Each time a SAFE signature is used, it uniquely identifies the signer and creates a permanent date and time record of its use.
Identity credentialing and managing, retrieving and storing paper documents add significant cost to the pharmaceutical and healthcare industries.
SAFE-Biopharma estimates that more than $1 billion is spent annually for identity credentialing in both industries.
In addition, SAFE-Biopharma notes that paper documentation contributes to as much as 40 percent ($9 billion in the United States alone) of all pharmaceutical research and development cost and to as much as 30 percent of all healthcare delivery cost.
The SAFE-BioPharma Association said it provides a mechanism to reduce these costs and realize efficiencies through the migration from paper to electronic documents.