Electronic Signature Standard Aims To Speed Document FlowElectronic Signature Standard Aims To Speed Document Flow

A coalition of biopharmaceutical companies, the leading pharmaceutical industry organization, and government agencies has developed an electronic signature standard to improve the flow of electronic documents throughout the pharmaceutical industry.

The standard, unveiled Wednesday, includes digital-identity technical specifications, policies, and guidelines, and a legal infrastructure developed under the Secure Access For Everyone (Safe) project. The standard provides legally enforceable digital signatures that meet global regulatory requirements, according to the standard's backers.

Electronic signatures are needed for the growing number of electronic documents exchanged in business-partner relationships and for electronic submissions to government regulators. Use of a single standard will help eliminate proprietary digital-identity models, reduce costs, and enable technological interoperability between pharmaceutical companies and other organizations, Gary Secrest, worldwide information security director at Johnson & Johnson and Safe chairman, said in a statement.

The Safe initiative was sponsored by the Pharmaceutical Research and Manufacturers Association and a number of major pharmaceutical makers, including Aventis, GlaxoSmithKline, Eli Lilly, and Pfizer. The association and the drugmakers worked with the Food and Drug Administration, the European Medicines Agency, and the European Federation of Pharmaceutical Manufacturers Associations in developing the standard.

Software vendors that provide document-management applications to the pharmaceutical industry are also expected to adopt the standard. Open Text Corp., which markets content management software for pharmaceutical companies, said Wednesday that it will support the standard in its products.

The Safe standard will also be the topic of several sessions and technology demonstrations at the Drug Information Association conference next week in Washington.