CIMdata PLM Industry Summary Online Archive
5 April 2007
Product News
Fullscope Announces FDA Validation Workbench
Fullscope, Inc ., a Microsoft Gold Certified business partner, announced the availability of a new software and services product, FDA Validation Workbench, designed to assist life sciences companies to achieve and maintain U.S. Food and Drug Administration (FDA) validation. The new option complements Process Industries for Microsoft Dynamics AX, supply chain management software also developed by Fullscope as part of the Microsoft Business Solutions Industry Builder ISV (IBI) program.
Companies that manufacture medical devices, pharmaceuticals or other regulated substances must demonstrate that they can meet the processing, safety and tracking standards required by law. Fullscope's FDA Validation Workbench includes software for tracking and managing validation activities, templates for completing the documentation required by the U.S. FDA, documentation for a vendor audit of Process Industries for Microsoft Dynamics AX, and consulting services to assist the manufacturer in completing the validation process.
"This product directly addresses one of the most difficult and time-consuming problems faced by life sciences manufacturers," said Russell Smith, president of Fullscope. "Until now, products targeting this issue have been expensive, complicated and cumbersome. With the new FDA Validation Workbench, a pharmaceutical manufacturer or other life sciences company can quickly and cost-effectively navigate the complicated validation process."
The U.S. FDA and other similar regulatory agencies worldwide validate a manufacturer's implementation and use of a vendor's software rather than the software itself, forcing each life sciences company to conduct a complete validation process. The software, documentation and services provided in the FDA Validation Workbench can help reduce the time and effort required by capturing as much of the standard information as possible from each manufacturer.
Templates in the FDA Validation Toolkit include:
• Validation Master Plan (with risk assessment)
• Software Plan
• Requirements Disaster Recovery
• Software Traceability
• Validation Test Plan
• Supplier Audit Check List
• Internal Procedures
• Signature Matrix
• Validation Standard Operating Procedures
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation Summary Report
Additional software provides users with tools to manage the validation process, track company-specific changes made to Microsoft Dynamics AX, and monitor on-going compliance status. The consulting services include on-site assistance from experienced validation consultants to implement the software, plan the validation project and complete the templates.
About Microsoft Industry Builder ISV (IBI)
The Microsoft Business Solutions Industry Builder ISV program combines the company's global reach with the strength of locally focused reseller and services partners. Through IBI, Microsoft markets business management software solutions developed by independent software vendors. These solutions extend and enhance the functionality of Microsoft Dynamics AX, expanding the industries and business functions supported. With the Microsoft IBI program, manufacturers can deploy global solutions tailored to local issues and receive local support.
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