Axapta Releases Life Sciences Edition

Axapta for Life Sciences, a special life sciences edition of Microsoft’s high-end business management package, will ship in the first quarter of 2005 in North America and Europe. Based on Axapta 3.0, the release could reduce burdensome manual work that companies such as drug and medical device manufacturers expend to meet government regulations. In addition, the release opens opportunities for Microsoft Business Solutions (MBS) and its partners in a well-funded, technology-savvy industry. However, the product is not an out-of-box solution, and company-specific solutions and customizations will need to be implemented by specially certified Microsoft partners.

Special Requirements

Companies in the life-sciences industry, such as pharmaceutical companies and medical device manufacturers, must comply with a set of manufacturing, processing, and documentation requirements referred to as Good Manufacturing Processes (GMPs), which are mandated by the United States Food and Drug Administration (FDA). For example, the GMPs include a byzantine specification referred to as “Part 11,” which outlines rules and restrictions governing the use of electronic records and electronic signatures in FDA documentation requirements (such as the documentation a drug manufacturer must maintain to track production lots).