Microsoft Business Solutions-Axapta 3.0 for Life Sciences

While most of us are awaiting release 4.0, Microsoft Business Solutions unveils Microsoft Axapta for Life Sciences. Microsoft Axapta for Life Sciences builds on the Axapta release 3.0 version and is scheduled for the first quarter of 2005.

Microsoft Axapta for Life Sciences will be available in the United States, the European Union, Canada and Switzerland.

When companies in the life sciences industry seek to implement new technologies, regulatory agencies must first validate that those implementations comply with Good Manufacturing Practice (GMPs). This is often a complicated and extensive undertaking. Microsoft Axapta for Life Sciences, in conjunction with industry-specific solutions from independent software vendors (ISV) or value-added resellers (VARs), is designed to simplify the validation process, making it more affordable for life sciences organizations.

Microsoft Axapta for Life Sciences has been developed specifically for the midmarket segment and divisions of large enterprises. It includes a set of functionalities that are broadly applicable across a variety of industries but are absolutely critical to the life sciences industry. Examples include electronic signatures and the improved control capabilities, which will make it easier for life sciences businesses to adhere to regulatory requirements.

Features and Functionality for Today’s Life Sciences Organizations

Key functionality included in Microsoft Axapta for Life Sciences can help provide manufacturers in the life sciences industry with the level of control over their operations mandated by the U.S. Food and Drug Administration (FDA). Even more broadly, any company in the world manufacturing products for U.S. distribution that the FDA would categorize in the life sciences industry must comply with FDA regulations. Such regulations are established by the FDA and other agencies worldwide to ensure the safety and efficacy of drugs and medical devices.

A key component of the Microsoft Axapta for Life Sciences platform is validation documentation. A crucial part of any validation process is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The solution’s validation documentation verifies compliance with regulatory requirements and allows significant simplification of the customer’s validation efforts.

Another key feature of Microsoft Axapta for Life Sciences is Part 11 compliance functionality. Part 11, passed in 1997, is an FDA mandate that sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and as valid as signatures on paper. As more manufacturers automate production, FDA inspectors are increasing their scrutiny of the systems those manufacturers use to manage the flow of materials and finished products through the plant. Therefore, Part 11 compliance is central to the compliance strategy of any life sciences manufacturer using systems to manage its business.

Microsoft Business Solutions has engaged with NNIT, a company 100 percent owned by the Novo Nordisk Group, to qualify Axapta for Life Sciences according to FDA regulatory requirements and to certify partners’ software development processes. This certification can help save customers the time and expense of engaging in a supplier audit of their own before they decide to purchase a solution.