6/14/2016gqsi, llc1 Validation Services: Medical Device, Biotechnology, and Pharmaceutical Industry

6/14/2016gqsi, 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 (# )

6/14/2016gqsi, llc3 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

6/14/2016gqsi, llc4 OEM Engineering Launch Support Launch Support – GQSI has provided the following US OEM Facility, Product, and Process Launch Support:  Medtronic – 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

6/14/2016gqsi, llc5 QUALITY SYSTEMS and STANDARDS ISO 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

6/14/2016gqsi, llc6 GQSI SERVICES THE FOLLOWING INDUSTRIES: MEDICAL DEVICES BIOLOGICAL TISSUES PHARMACEUTICAL LOGISTICS ELECTRONIC CHEMICAL ENVIRONMENTAL AUTOMOTIVE AEROSPACE Industry Support

6/14/2016gqsi, llc7 GQSI Locations MEMPHIS, TN DETROIT, MI ST. LOUIS, MO BIRMINGHAM, AL

6/14/2016gqsi, llc8 Leadership Will Graham, President Over 20 years experience in New Product Launch, Engineering Support, and Equipment and Process Validations ISO 9000 certified Lead Auditor ISO9001 and ISO9002 certified Lead Assessor BS in Chemistry and Biology, University of Missouri George Graham, VP Business Development Lawyer, profit and nonprofit corporate affairs Over 20 years in Certified Public Accountant BS/BA Business, University of Missouri JD degree in Law, St. Louis University Certification in International Law, University of Brussels

6/14/2016gqsi, llc9 Leadership Kerry Turner, Engineering Director Over 20 years experience in Quality, Manufacturing and Process Development Customer Liaison Industrial, Design and Process Engineering B.S. Mfg. Engineering, University of Missouri Bill Phelps, Regional Manager Over 20 years experience in Lean Manufacturing and Facility and Product Validations Industrial, Design and Process Engineering B.S. Industrial Engineering, University of Illinois Univ. of MO