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IFS Application Software Validation and Nordson Medical

Nordson MEDICAL is a global expert in the design, development and manufacturing of complex medical devices and component technologies. Nordson MEDICAL serves interventional, surgical and specialized markets as the engine of innovations that saves or enhances patient lives. Arbour Group completed a validation of a comprehensive set of modules for Nordson MEDICAL. A strategy was deployed to standardize on IFS Applications throughout the organization as the single supply chain management software. The IFS Applications solution also allows business integration of processes and data across multiple locations. The user interface of the application provides users the ability to organize tasks and roles within their work environment.

Implementing IFS Application

Arbour Group performed consulting services related to a risk-based validation of the regulated (GMP) uses of the core installation of IFS Applications. Validation included development of planning and requirements documents, writing and execution of test scripts and preparing summary documentation.  The validation ensures compliance with applicable regulatory guidance to include the US Food and Drug Administration (FDA) 21 CFR Parts 11 and 820 as well as applicable international regulations and industry best practices.

The Arbour Advantage

Arbour Group has been a trusted advisor to over 250 life sciences companies.  We can ensure that your IT policies and procedures contain the appropriate depth and breadth of coverage that will ensure regulatory compliance and reflect industry best practices. For more information, contact Arbour Group today!