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.

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