Press Releases

Recent News Press Releases Article Archive

Press Releases

Idiom Delivers Integrated Xml Global Electronic Publishing Solution For Pharmaceutical And Medical Industries

WorldServer™  Global Electronic Publishing Meets SPL and PIM Standards for Labeling Compliance

Waltham, Massachusetts, USA - March 7, 2005 - Idiom^® Technologies, Inc., the leading provider of XML-based global electronic publishing solutions, today announced its full support for U.S. Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMEA) mandated standards for pharmaceutical and medical labeling.

Regulatory agencies in the US and Europe are requiring pharmaceutical and healthcare device companies to utilize XML for the electronic submission of labeling and product information. This trend is likely to evolve further to include additional XML-based submission requirements for information such as health records and clinical trial protocols.

For example, an article entitled "The Future of Labeling", in the January issue of Pharamceutical Executive states that by fall 2005, the FDA plans to accept labeling submissions for prescription drugs only in Structured Product Labeling (SPL) form. By the end of 2007 the requirement to submit labeling information in SPL will extend to all FDA-regulated products: OTC medications, devices, diagnostics, veterinary medicines, or any product with package information or a package insert. In addition, the EU PIM standard is on a similar timeline and is as comprehensive in scope.

WorldServer™  Global Electronic Publishing solutions enable Idiom customers to more rapidly migrate product information to XML and globally publish that content in SPL and PIM compliant formats, in multiple languages simultaneously. WorldServer substantially reduces the cost and effort required to both meet regulatory standards, and package, localize, and release pharmaceutical products globally.

Migration to XML authoring and publishing using the standards-based WorldServer OpenTopic framework provides compelling benefits:

- Eliminate redundancy and non-compliance by reusing only approved product content, authored and managed in XML

- Reduce costs through business process automation and reuse of previously approved translations

- Accelerate time-to-market by automating the label creation, approval, and publishing process

Importantly, WorldServer integrates seamlessly with Enterprise Content Management (ECM) solutions from vendors such as Documentum, which enables users to navigate, translate, and transform content directly from existing content repositories. As a result, pharmaceutical and medical device companies can continue to leverage their existing ECM investments, while efficiently addressing the complexities of publishing multilingual, multicultural labeling and packaging content.

"Pharmaceutical and medical device companies should move to XML-based publishing solutions like Idiom WorldServer now," states Eric Silberstein, Founder and CTO of Idiom Technologies. "Not only is it necessary for government-mandated electronic submissions, but the benefits in terms of resource savings and effective reuse of approved product information, particularly when faced with disseminating information in different languages - are unrivaled."

About SPL

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging medication information. For more information, please visit www.fda.gov or www.hl7.org.

About PIM

Product Information Management (PIM) is a joint project of the European Agency for the Evaluation of Medicinal Products (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) initiated to design, develop and pilot secure electronic submission of product information to competent authorities of the European Union. For more information, please visit www.emea.eu.int or www.efpia.org.

About Idiom Technologies

Idiom uniquely combines the power of a modern XML publishing platform with market leading globalization capabilities to deliver the only end-to-end enterprise software solution for authoring, managing, and publishing content in any format and any language. Since 1998, Idiom has been helping companies such as Adobe Systems, Baxter Healthcare, Caterpillar, Medtronic, Motorola, and Oracle accelerate time-to-market, ensure content quality, and improve global customer satisfaction.

The company is headquartered in Waltham, Massachusetts, with offices throughout North America and in Europe. To learn more please visit www.idiominc.com or call +1 781.464.6000.



# # #
Idiom and WorldServer are trademarks, or registered trademarks of Idiom Technologies, Inc. All other brand names, product names, or trademarks belong to their respective holders.