xmLabeling Release 4 offers the unique ability of generating data in either Structured Product Labeling (SPL), Product Information Management (PIM) or other regulatory formats as required, from a single content source.
This feature will bring relief to many pharma companies who are struggling to manage the complexities of circulating and publishing drug labelling documentation according to the new requirements of the regulatory authorities in the US and Europe.
"This product is unique in that we offer a single place to create, edit, approve, manage as well as generate labelling content according to the individual regulatory requirements of each country," company spokesperson Ken Lownie told In-PharmaTechnologist.com.
Two global pharma companies have already implemented the software and Glemser expects 8 to 10 more companies will do so this year, with a complete implementation of the solution costing between $400,000 (€330,000) and $1m.
"At the moment we are focusing on the US and European markets, however, the software has also been designed to apply to Asian and South American countries and we will expand into these markets in the future," he said.
The product is built on Documentum's WebTop interface to offer ease of integration, and stores labeling content in an XML format, which essentially compartmentalises the data, making the reuse of labeling content easier.
This feature, available in the previous version of xmLabeling, is already saving companies such as Pfizer millions of dollars through streamlining and centralising the use of labeling content throughout the company's global locations.
"With this product our clients can get all the elements of a complete labeling solution from a single source," said company president, Ray Glemser.
"As a result, they can lower their technology risks by implementing a commercial, off-the-shelf solution and obtain a single point of accountability as they move through their implementation," he said.