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SERVICES

With experience ranging from Quality to Facilities Validation and Management and Information Technology, Bryan Hudson at Summit Quality can guide you and your group to achieving compliance.  Highlights of available services are included below.  Looking for something that you do not see?  Please contact us.   

GxP Quality Assurance

  • Overall strategic quality vision and direction for compliance with federal and local regulations

  • Interface and managing, hosting, and responding to FDA and EMA audits

  • Third party supplier audits

  • Client and Supplier Quality Agreements

  • Document Management Systems

  • Internal Auditing Program

  • Regulatory licensure and inspections (FDA, NRC, State licenses)

  • Deviations and Investigations, CAPA Program

  • Laboratory Information Management System (LIMS) setup, interface, and execution

  • GMP Labeling and Packaging, including Batch Record development, material design and release, and QA oversight

  • New method validation and method transfer 

Facilities Validation and Management

  • Facility Master Validation Plan and associated validations

  • Business Continuity Planning:  backup redundancies including diesel generators, equipment and supplier contingency identification, mock disaster drills

  • Test protocol development

  • Temperature mapping of multiple zones

  • Warehouse Management System (WMS)

  • Building management System (BMS)

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  • Enterprise Planning System (ERP)

  • Generate equipment user requirement specifications

  • Vendor interface throughout procurement and installation

  • Commissioning and validation protocols for critical systems (air, water, steam, gas)

  • Calibration and maintenance programs

Information Technology

  • 21 CFR Part 11 Validation Program and lifecycle maintenance

  • Software validation 

  • SOP generation and implementation

  • Inventory assessment, gap analysis, and risk mitigation planning

  • IT core network infrastructure qualification

  • Cloud hosting of 21 CFR 11 systems

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