REDMOND, Wash, Nov. 1, 2004 — Microsoft Business Solutions today announced upcoming availability of Microsoft® Business Solutions–Axapta®
3.0 for Life Sciences. Scheduled for release in the first quarter of 2005, Microsoft Axapta for Life Sciences is a preconfigured solution designed to address and greatly simplify the regulatory compliance issues unique to the life sciences industry, which includes organizations that conduct research and produce pharmaceuticals, biotechnology and medical devices.
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. Although Microsoft Axapta for Life Sciences will provide a strong industry-specific technology platform, customers will continue to get the vertically specific functionality they require through ISV and VAR business partners that have a deep level of industry expertise.
Several of Microsoft Business Solutions’ ISV partners have already expressed their support for Microsoft Axapta for Life Sciences. “Microsoft is truly a partner-driven organization,” said Egon stergaard, CEO of the Thy Data Center A/S, Denmark. “The release of Microsoft Axapta for Life Sciences shows that Microsoft understands the needs of life sciences organizations and how ISVs like Thy Data Center can build on a solid foundation of applications to meet the stringent requirements of this industry. Thy Data Center is proud to be able to bring to market our skills and solutions on top of this new, very professional platform, which already has proved its qualities.”
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.
“Our research shows that life sciences manufacturers pay a significant amount of money to have validation consultants create this documentation from scratch,” said Melissa Paulik, senior life sciences industry product manager for Microsoft Business Solutions. “By providing this documentation through our business partners, we are making a life sciences industry solution affordable to the midmarket segment.”
Another key feature of Microsoft Axapta for Life Sciences, according to Paulik, 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.
Availability
Microsoft Axapta for Life Sciences will be available in the United States, the European Union, Canada and Switzerland.
About Microsoft Business Solutions
Microsoft Business Solutions offers integrated business applications and services that allow small and midsize organizations and divisions of large enterprises to connect employees, customers and suppliers for improved efficiency. The financial management, customer relationship management, supply chain management and analytics applications work with Microsoft products such as Office and Windows®
to streamline processes across an entire organization, giving businesses insight to respond rapidly, plan strategically and execute quickly. Microsoft Business Solutions applications are delivered through a worldwide network of channel partners that provide specialized services and local support tailored to a company’s needs.
About Microsoft
Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services and solutions that help people and businesses realize their full potential.
Microsoft, Axapta and Windows are either registered trademarks or trademarks of Microsoft Corp., Microsoft Business Solutions APS or their affiliates in the United States and/or other countries.
Microsoft Business Solutions ApS is a wholly owned subsidiary of Microsoft Corp.
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