Advanced Radiation Therapy Device Manufacturer
Implements & Validates Microsoft Dynamics AX 2009
Case Study
Major Medical Device Manufacturer Implements & Validates Microsoft Dynamics AX 2009
The priority goal was the consolidation and global deployment of the integrated ERP system and new enhanced functionality.
Consolidated Financial Reporting
Integrated Quality Management
eDHR / DMR Management
The system was deployed
21 CFR Part 11 Electronic Records; Electronic Signatures
21 CFR 820.30 Device Design Controls
21 CFR 820.100 CAPA
Ensure Compliance And Business Continuity
Maintain Spares Inventory in Multiple Locations
System Validation & Verification
21 CFR Part 11 Compliance
Management Of Multiple Warehouses And Perform Requirements Planning On Multiple, Nettable Warehouses
Eliminate The Disparity Between The Sales Order Installation And Planned Shipment Date
Streamline Rework Orders Process
New Enhanced Approved Supplier List
Purchase Toolkit and/or Automated Validation Software Tool
Did the client purchase the
FDA Validation Toolkit?
yes
Did the client purchase the automated
validation software tool?
no
onshore professional services
Methodology and approach
To achieve the objectives for this client, Fullscope assembled a team of qualified professionals to assess client needs and deliver the enhancements identified by their requirements. The team worked together as a joint team to accomplish the project objectives. Microsoft SureStep was leveraged as the project methodology to ensure that all requirements were document and the project was managed in a manner consistent with project management best practices. GAMP 5 is the methodology of choice leveraged for the FDA Validation Toolkit. All validation deliverables and test documentation was developed in a manner consistent with GAMP 5. The approach for this implementation was to migrate the legacy data from the existing systems and validate the new enhanced systems according to GAMP 5 and FDA validation guidelines.
Results
Impacts and outcomes
The FDA validation toolkit was used to streamline validation efforts. The templates and validation processes developed were used by the company to develop a corporate approach for validation and the test scripts were used to validate the system. All functionality and enhancements were delivered to the client as agreed.
Conclusions
The client acquired a new company and needed to leverage the validation documentation previously used and bring the new location online in a compliant manner. After the first successful implementation, the previous validation processes and documentation to validate the new location. In selecting Microsoft Dynamics AX 2009, the customer needed the confidence that the system could be validated in a compliant manner. In addition to the many features delivered by the integrated Microsoft Dynamics AX 2009 system, the customer achieved the following key business benefits: