Case Study #2: MES Implementation for Medical Device Company
Business Challeges
- Tracking manufacturing subcontracting activities
- Regulatory Compliance
- Manual exchange of information with ERP
- Tool Integration
Objectives
- Implement MES system to comply for FDA standards
- Import process critical data from subcontract into MES
- Detailed Genealogy tracing in the new system to prevent any manual errors.
- Integrate tool data into MES for binning
Value Delivered by Dhruv
- Built solution design while identifying the CRs (Change requests.)
- Camstar 6.13 Med Device Suite was used for the implementation.
- CAMSTAR CIO was used for vendor data and tool data integration into MES.
- Integrated CAMSTAR with SAP through Mulesoft integration layer to eliminate manual process.
- Worked with the customer team in performing validations and verifications (regulatory requirement) activities for system changes.
- Implementation of Non Conformance and Equipment Maintenance solution.
Location:
USA
3 Factories – Wafer Fab, Reagent and Assembly.
Industry:
DNA Sequencer Manufacturing
Partnership Period:
January 2015 – Present
Team Size:
#12
Team Location
Offshore, Development Center
Expertise Delivered
MES Implementation
Technologies
.NET v4.0, SQL Server 2014, IIS 7
