Product category:
Enterprise Resource Planning software (ERP)
News Release from: Microsoft Dynamics | Subject: Axapta 3.0 for Life Sciences
Edited by the Manufacturingtalk Editorial
Team on 05 November 2004
Axapta for Life Sciences
Microsoft Is Poised to Expand Opportunity To Offer Life Sciences Customers a Compliance-Enabled Solution at an Affordable Price
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
This article was originally published on Manufacturingtalk on 25 Feb 2003 at 8.00am (UK)
Related stories
IT services operator takes up Microsoft agency
Microsoft Business Solutions has announced that Steria, a leading European IT services operator, has become an authorised Axapta channel partner in the UK.
IT partner signed up as reseller
Microsoft Business Solutions has announced that it has signed up leading IT solutions supplier, gedas UK, as a partner for its Axapta reseller channel.
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.
Further reading
New finance option for complete IT solutions
Businesses can now finance a total solution purchased from a Microsoft Certified Business Solutions Partner at competitive rates and convenient terms
Microsoft invests in ERP solutions
Microsoft Business Solutions has made a series of announcements focused on enhancing and supporting its current line of enterprise resource planning (ERP) business solutions and service offerings.
Leam manufacturing modules developed
eBECS, a leading Microsoft Business Solutions' partner, has developed a complete series of Lean Manufacturing modules designed to complement and enhance the functionality of Microsoft's Axapta.
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 Ostergaard, CEO of the The Data Centre 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 Centre can build on a solid foundation of applications to meet the stringent requirements of this industry.
Thy Data Centre 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." 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.
Microsoft Axapta for Life Sciences will be available in the United States, the European Union, Canada and Switzerland.
• Microsoft Dynamics: contact details and other news
• Email this article to a colleague
• Register for the free Manufacturingtalk email newsletter
• Manufacturingtalk Home Page
Search the Pro-Talk network of sites
