By Mike Anello

Technological advances and globalization are forever changing the way the world conducts business. Enterprises and economies that once operated separately now find themselves increasingly enmeshed with new competitive partners, working together on common ground to push innovation and progress and ensure viability in an increasingly complex marketplace. Standardized digital signature and identity technologies are a means for the industry to continue to become more efficient in the face of these challenges.

Biopharm’s Business Problem
Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association, believes there are two aspects to the business problem facing the biopharmaceutical industry today. “The FDA and the European Medicines Evaluation Agency [EMEA] have clearly stated that in the next several years they are going to require electronic receipt and review of regulatory submissions. The FDA already requires electronic submissions for safety reports. The EMEA has stated it recommends the Electronic Common Technical Document [ECTD] format, and that it would prefer only electronic as of this year. This is really guidance meaning, ‘better do it now because it’s just a matter of time.’”

The ECTD is essentially a single dossier that companies can submit to regulatory authorities in different countries that allow for product approval in the United States, Europe, and Japan without the necessity of keeping separate dossiers for submission. There may be elements of a dossier that vary according to various regulatory jurisdictions, but the use of ECTD essentially eliminates duplicative paperwork.

The second aspect of the business problem is for entities to move toward the efficiency of interoperability in a global economic environment. The biopharmaceutical industry is becoming increasingly partnered with CROs, CMOs, and CSOs at every step of the process from discovery through marketing. “The industry is running global clinical trials all over the world,” says Shields-Uehling. “If you look at the cost and time of moving paper, Fedexing, Xeroxing, and storage, it’s a very costly, cumbersome, and antienvironmental process. One of the things the industry is aware of is that it really needs to take advantage of the cost savings and process efficiencies it can achieve by going fully electronic.”

Many firms are currently using some form of electronic signature or submission to regulatory agencies. However, faxed submissions or submissions scanned to CD fail to take full advantage of the enormous benefits that can be realized by embracing a fully electronic model. Issues surrounding the business process of biopharmaceutical companies have been of concern. Would regulators recognize digital signatures? Would the signatures comply with 21 CFR Part 11? Would regulators be able to audit electronic signatures?

The Safe Signature And Digital Identity Standard
Early in 2004, some of the leading pharmaceutical companies came together and discussed ways to address some of the issues keeping the industry from going fully electronic. After meeting to develop standards and establish a legal entity, the SAFE-BioPharma Association was established as a nonprofit legal entity.

SAFE is a nonprofit industry collaboration and association, which is operated by the world’s major pharmaceutical companies. The eight companies that founded SAFE are AstraZeneca, Pfizer, Johnson and Johnson, Proctor and Gamble, Sanofi Aventis, Merck, Bristol-Myers Squibb, and GlaxoSmithKline. Those members still sit on the board today, along with Amgen and Argonon.

The driving purpose behind SAFE-BioPharma was to create an interoperable system for digital security, signatures, and submissions. The SAFE association, along with the FDA and the EMEA, developed the SAFE standard, which is interoperable across all member firms. International law firms were consulted to ensure the standard mapped to the European Union, U.S., Japanese, and Australian laws, providing a truly global solution.

Components Of The SAFE Standard
The first component is a set of identity standards. Shields-Uehling states, “SAFE requires you have to do something called a face-to-face identity verification process, which is like the I-9 process a person has to go through when they get a job. Although we can rely on a previous I-9 type of vetting, we have an online procedure, which is quite secure and trustworthy in terms of determining if that person is who they say they are.”

The second component of the SAFE standard involves the technical aspects of the system. Shields-Uehling explains that, “When you are identity-proofed, at the end of the process you get a safe credential or certificate, which can be a software certificate that you download onto your computer, or a USB fob, or it can be something called a digital roaming ID, which at this point, is also a USB fob, but one that you can carry around with you and use on any computer.”

The third component is a set of legal provisions that member firms must agree to in order to accept SAFE signatures, and they must agree to be governed by arbitration rather than litigation. The member firms agree that these are indeed SAFE signatures, that you will accept them as a valid signature, and you will sign them as a legally binding signature.

Once the standard was created, the association needed a set of services to help the standard function properly. Members are invested in a set of identity proofing and credentialing services that SAFE offers through an outsourced contractor. Companies come to SAFE to credential their partners, investigators, and many times their employees. The identity-proofing and the credentialing services are performed at cost and available only to members.

Digital Standards Can Help Facilitate Industry Modernization
The breadth of the SAFE standard is wide-ranging. Member companies are currently implementing SAFE in regulatory submissions, e-lab notebooks, and in interaction with external partners. Shields-Uehling sees a logical progression toward U.S. government interaction with the SAFE standard. The federal government also operates a similar system standard that is cross-certified with SAFE. The government standard includes identity-proofing and technical requirements. Shields-Uehling explains that, “The rules are equivalent to the federal rules, and they recognize a SAFE digital identity as equivalent to a federally digital identity. We believe there will be great usage in terms of e-government to pharmaceutical processes, as well as the broader healthcare space.”

As the healthcare industry moves to electronic health records and electronic prescribing, its systems will ultimately require some type of identity management and digital signature scheme or multiple schemes that are federated together. What makes SAFE unique is that it is interoperable across corporate, industrial, and national interests.

Another major utilization of the SAFE standard has been in the area of electronic lab notebooks, chemistry lab notebooks, and biobooks. These documents are crucial to the approval process and are often used in patent disputes. Moving to a fully digital standard saves time and eliminates much of the cumbersome physical presence of these notebooks.

The Group Purchasing Organization (GPO), a consortium of U.S. hospitals working together to lower costs, is also using the SAFE standard. The group makes purchases for approximately 1,600 hospitals and purchases from 600 to 800 suppliers. The GPO has recently completed a pilot and is moving forward with a major implementation using SAFE to digitally sign electronic contracts, which is helping move the GPO into an electronic contracting environment.

Many enterprises are beginning to understand the gains in efficiency and cost-savings benefits offered by moving away from the paper trail toward a fully digital environment. Shields-Uehling sees the value of SAFE in complete interoperability and the creation of a very large network. “Enabling multiple parties across the sector to be able to do business with one another contributes to the value of an interoperable digital identity standard,” she says. In fact, Safe- BioPharma’s stated goal is to transform the healthcare and biopharmaceutical industries to a fully electronic business environment by 2012.

Those who wish to learn more about digital identity and signature standards can find excellent resources at www.safe-biopharma.org. SAFE offers webinars, case studies, and other media designed to help companies make a smooth transition to a more efficient and cost-effective fully digital environment.