Thomson Scientific & Healthcare, a part of The Thomson Corporation, has announced a solution to meet the Structured Product Labeling (SPL) challenge. Thomson expects to enable pharmaceutical companies to submit labeling and immediately go to market with labeling in the impending FDA-required format.
By mid-to-late 2005, the FDA wants to timely and accurately receive prescription product labeling electronically in XML format to help improve patient safety. To ensure compliance, life sciences companies face new challenges, including converting existing labeling to SPL format, producing new labeling in SPL format, and managing the information at a much greater level of detail. To address the challenges faced by their customers, Thomson offers the following solutions: outsourced label conversion using Liquent Direct and transformation and lifecycle management technology via Liquent InSight Manager for Labeling. Both will support 21 CFR Part 11 compliance. When life sciences companies turn to Liquent for SPL services, the Liquent team of regulatory experts uses proprietary technologies to convert their labels into the standard format. Once converted and checked for accuracy, companies can then go through their normal quality assurance and approval cycles.