Food & Beverage

Chemicals

Life Science & Pharmaceutical

Primary Metals

Pulp & Paper

Fullscope helps medical device manufacturers address two distinct operational challenges: running efficient discrete production activities while maintaining FDA compliance.

Efficient Discrete Production Activities
Designed for mid-size and larger companies, Microsoft Dynamics AX is a multi-language, multicurrency enterprise resource planning (ERP) solution. Its core strengths are in manufacturing and order processing.

Microsoft Dynamics AX has over 5000 users worldwide and frequently replaces Oracle and SAP. It is sold only by authorized Microsoft resellers like Fullscope, and includes applications for financials, CRM, SCM, human resources, project management and analytics.

Because it integrates with widely-familiar Microsoft products such as Microsoft SQL Server, BizTalk Server, Exchange, Office, and Window, employees can work with the tools they are likely to be already familiar with, lowering training costs.

FDA Compliance
Medical device manufacturers have discrete/hybrid production processes that rely on bills of material (BOMs), but they must meet the same FDA compliance guidelines as pharmaceutical/life sciences companies that have formula-driven production processes.

All companies that produce regulated devices or substances must demonstrate that they can meet the processing, safety and tracking standards required by law. Fullscope’s FDA Validation Workbench 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.

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 medical devices company to conduct a complete validation process. The software, documentation and services provided in Fullscope’s FDA Validation Workbench can help reduce the time and effort required by capturing as much of the standard information as possible from each manufacturer.