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Quality Digest

FDA Compliance

New FDA-Required Labeling Solution Introduced

Published: Tuesday, February 22, 2005 - 23:00

Thomson Scientific & Healthcare Corp., a provider of integrated information products for the health care industry, recently introduced a new pharmaceutical product labeling solution that complies with impending FDA regulations. Thomson is now offering outsourced label conversion using its Liquent InSight Manager and Liquent Direct transformation lifecycle management technology for pharmaceutical product labeling. Both approaches comply with 21 CFR Part 11. The use of the products will also comply with the FDA’s Structured Product Labeling challenge, which requires pharmaceutical companies to submit prescription product labeling electronically in XML format to help improve patient safety. This requires a much greater level of detail than is currently commonly used. Compliance to the regulation will be mandatory in mid- to late 2005.

When companies use Liquent for their SPL services, the Liquent team of regulatory experts uses proprietary technologies to quickly convert their labels into the standard format. Once converted and checked for accuracy, companies can go through their normal quality assurance and approval cycles.

“The U.S. pharmaceutical industry and the FDA are both moving rapidly to make professional labeling for prescription products available electronically to practitioners to facilitate access to the very latest prescribing information to promote greater patient safety,” says Dave Duplay, Thomson executive vice president. “SPL readies Thomson for timely introduction of this important advance in drug information technology.”

Thomson Scientific & Healthcare is part of The Thomson Corp. For more information, visit www.thomson.com.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.