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Fullscope's FDA Validation Workbench is 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.
Who Needs It 
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.
How It Works
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.
Software & Services
Additional software in the FDA toolkit 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 feature 25 days of on-site assistance from
experienced validation consultants to implement the software, plan
the validation project and complete the templates.
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Fullscope FDA Toolkit for Microsoft Dynamics
AX
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Templates included:
- 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
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