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6/25/2016gqsi, llc1 UDI and Traditional Laser Marking, Sterile and Non-Sterile Inspection and Packaging, Cleaning and Passivation, and Validation Services:

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Presentation on theme: "6/25/2016gqsi, llc1 UDI and Traditional Laser Marking, Sterile and Non-Sterile Inspection and Packaging, Cleaning and Passivation, and Validation Services:"— Presentation transcript:

1 6/25/2016gqsi, llc1 UDI and Traditional Laser Marking, Sterile and Non-Sterile Inspection and Packaging, Cleaning and Passivation, and Validation Services: Medical Device, Biotechnology, and Pharmaceutical Industry

2 6/25/2016gqsi, llc2 Mission Statement We are dedicated to providing 100% customer satisfaction, while maintaining our total commitment to Quality. “We Help Make Good Things Better” Certifications ANSI/ISO/ASQ 9001:2000 Certified (#20031) Tennessee-Minority Supplier Development Council (TN-MSDC) Certified (#0912-0303)

3 6/25/2016gqsi, llc3 Medical Device Industry – Implants and Non-Implants State of the Art FOBA M2000 and M3000 Series Laser Marking Intelligent Mark Position Vision System Materials: Metals - 17-4 SS, 300 Series SS, 400 Series SS, Ti, Al, CoCr Plastics - POM-C, POM, H, PPSU, PEEK, PMMA, Polypropylene, PTFE, ABS, Polycarbonate Compliant with 21CFR801.45 Fully Validated Systems GQSI - US OEM and Supplier UDI and Traditional Laser Marking Services:

4 6/25/2016gqsi, llc4  Medical Device Industry – Implants and Non-Implants  State of the Art Belco Sealers and Tunnels  UDI and Traditional Label and Packaging Services  Clean Room – Class 8 Environment  Seal validation  Tray sealing (single and double barriers)  Pouch sealing  Labeling  Distribution Services  GSI Barcode in linear form  GSI barcode in 2D datamatrix format  Fully Validated Systems GQSI - US OEM and Supplier Sterile and Non-Sterile Inspection and Packaging Services:

5 6/25/2016gqsi, llc5 Medical Device Industry – Implants and Non-Implants State of the Art ESMA Dual Model E992 Heated System with Rinse Tanks Citric and Nitric Passivation System Fully Validated Systems GQSI - US OEM and Supplier Cleaning and Passivation Services:

6 6/25/2016GQSI, llc6 Validation Services WE OFFER A VARIETY OF SERVICES: Equipment Installation, Operational, and Performance Qualification Validations Master Plan Facility Qualification Clean Room Certification Test Equipment Qualification Process Equipment Validation Computer Validation Cleaning Validation Temperature Mapping

7 6/25/2016gqsi, llc7 OEM Engineering Launch Support Launch Support – GQSI has provided the following US OEM Facility, Product, and Process Launch Support:  Memphis, Fort Worth, Los Angeles Engineering - Determine Validation Methods and Validation Protocols (Installation, Operation, Performance and Process Operational Qualifications) Analyze Validation Data, Investigate Failures and CAPA’s Develop Validation Master Plan (VMP), validation site and activity Biological Tissue and Medical Device Operations –Product and Process Validation - including Control Documents and Final Reports Generation for new and relocated equipment Multi-Facilities Validation Products – Medical and Biomedical Equipment and Devices including Human Tissue

8 6/25/2016gqsi, llc8 QUALITY SYSTEMS and STANDARDS ISO 13485 ISO14971 ISO 9000 Series cGMP FDA ASTM EPA DNR ADDITIONAL SUPPORT & TRAINING LOGISTICS AND MANUFACTURING SUPPORT SERVICES CONTAINMENT SERVICES AUDIT SERVICES ENGINEERING SUPPORT SUPPLIER SUPPORT SERVICES VALIDATION MASTER PLAN FULLY TRAINED INSPECTORS INTERNAL & EXTERNAL AUDITING SERVICES CUSTOMER LIAISON PROJECT MANAGEMENT Core Strengths

9 6/25/2016gqsi, llc9 GQSI SERVICES THE FOLLOWING INDUSTRIES: MEDICAL DEVICES BIOLOGICAL TISSUES PHARMACEUTICAL LOGISTICS ELECTRONIC CHEMICAL ENVIRONMENTAL AUTOMOTIVE AEROSPACE Industry Support

10 6/25/2016gqsi, llc10 GQSI Locations MEMPHIS, TN DETROIT, MI ST. LOUIS, MO BIRMINGHAM, AL

11 6/25/2016gqsi, llc11 Leadership Will Graham, President Over 25 years experience in New Product Launch, Process Development, Engineering Support, and Equipment and Process Validations George Graham, CPA, JD - CFO and Head Legal Counsel Over 20 years in Accounting and Law Certification in International Law, University of Brussels


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