Microsoft Launches Business Solutions-Axapta for Life Sciences

Microsoft Business Solutions 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 the regulatory compliance issues unique to the life sciences industry, which includes organizations that conduct research and produce pharmaceuticals, biotechnology and medical devices.

"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."

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.

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).

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.