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Commissioning, Qualification, and Validation (CQV)

Global Turn-Key Services (GTKS) is a leader in total project support for the pharmaceutical, biotechnology, and medical device industries. We specialize in project delivery services that emphasize our ability to provide efficient, dependable, and accurate projects while driving business performance. With clientele all over the United States and Puerto Rico, we ensure our staff has a variety of skills to seamlessly integrate into your business. GTKS strives to set all-inclusive measurable goals, gather talented resources, and create a plan of action to be implemented in a timely and cost-effective manner. We have successfully managed projects ranging from $0.5MM to $150MM in TIC.

The commissioning and qualification specialty of Global Turn Key Services (GTKS) focuses on facilities, processes, and manufacturing in the Pharmaceutical, Biotechnology, and Medical Device industries.

We provide a full range of services in startup, commissioning, qualification, validation, maintenance programs, training, operational procedures, and other regulatory compliance services for the Pharmaceutical, Biotechnology, Medical Device, and Chemical Industry.

GTKS CQV division specializes in:

  • Startup of production facilities
    • Facilities
    • Clean and Plant Utilities
    • HVAC
    • Process Equipment
    • Control Systems (BMS, PLC based, DCS)
  • Commissioning, qualification and validation of processes and facilities to ensure compliance and approval to meet design specification.
  • Coordination and acting as liaison for project between the owner, design, commissioning, startup, validation, and  the various owner groups (e.g. manufacturing engineering, maintenance, and quality)

GTKS works on projects ranging from single pieces of equipment or system to complete green-field manufacturing facilities. We are familiar with government regulatory requirements (e.g. FDA, EMEA, WHO, etc.), ISPE commissioning and qualification guidelines, ASTM E2500 Verification, EPCV, the “V-model”, and traditional validation approaches. Major services provided by GTKS CQV division include:

  • Commissioning / Qualification and Validation Planning
  • Early Project Planning
  • Coordination and Management of Vendors
  • Ensuring Overall Quality Compliance to Meet Client Specifications
  • Startup Coordination and Planning
  • Design Audit
  • FEMA Analysis
  • Development and Execution of Commissioning Documentation
  • Development and Execution of Validation Documentation
  • Preparation of Final Reports
  • FAT Documentation Coordination, Execution, and Oversight
  • Coordination Care-Custody-Control Turnover
  • Decommissioning
    • Initial Site Investigation
    • Project Cost Analysis
    • Historical File Review
    • Preliminary Site Survey
    • Decommissioning Plan Development
    • Technical Supervision
    • Regulatory Assistance
    • Waste Management

Areas of CQV Expertise:

  • • Startup, Commissioning, Qualification, and Validation Project Management
  • 21CFR Compliance
  • ASTM E-2500 Risk Based Approach
  • ISPE Commissioning & Qualification Guidelines
  • Validation Program Management
  • Process Validation
  • Cleaning Validation
  • Facility Qualification
  • Equipment Qualification (IQ, OQ, PQ)
  • Critical Utility Qualification (IQ, OQ, PQ)
  • Automated Systems Validation
  • Process Transfers/Validation
  • Analytical Method Validation and Stability Program
  • Decommissioning
    • Decommissioning Documentation
      • Protocol Development, Execution and Final Report
      • Equipment Exit PM Coordination and Database Update
      • Instrument Exit Calibration Coordination and Database Update
      • Spare Parts Inventory Reconciliation
      • Decontamination Studies
      • Validation File Reconciliation
    • Decommissioning Project Management
      • Project Plan Development and Execution
      • Project Schedule Development
      • Cost Control
      • Project Team Management

If you are looking for an experienced Commissioning & Qualification consultant
to assist with your project support needs

Contact Us Today