Commissioning Agents, Inc.

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Pharmaceutical, Biotech, Medical Device    |   Building Cx Services    |   Energy Services    |   Manufacturing and IT

Pharmaceutical, Biotech, Medical Device

  • Commissioning Services
  • Qualification & Validation
  • GxP Compliance Consulting
  • Manufacturing Support Services
  • Quality Risk Management

Commissioning Agents, Inc

Glen Doki

5 Years with CAI

 

Featured Project

Sterile fill/ finish facility using barrier isolator technology

Greenfield Sterile Fill/Finish Facility

Quality Risk Management

Genentech, Hillsboro OR

 

Commissioning Services

Commissioning Agents specializes in the commissioning and start-up of production facilities, including utilities, process equipment and control systems. Our commissioning projects have ranged from single systems to the largest biotech facilities. We assemble a team of the right size and experience to match your project needs before we bid the work.


Our teams can:

  • Provide project delivery services such as project management, commissioning or validation coordination for large and small projects, equipment integration engineering and expediting, and other specialized services.
  • Develop and implement commissioning plans.
  • Plan and coordinate the quality assurance activities of vendors, construction contractors, owners, and contract resources.
  • Develop commissioning inspection and test procedures, forms, and protocols tailored to project specifications to guide and document these activities.
  • Integrate our work within the overall project schedule, establishing an optimal system commissioning sequence to minimize project delivery timelines.
  • Document the inspections, start-up, and initial testing of equipment to streamline later validation activities.

When problems arise, we take charge, we take responsibility, and we ensure re-testing is thorough, documented, and completed quickly to stay on schedule. Our teams have the engineering, operational, and regulatory experience to identify and implement the best solutions for you, and for your project. Commissioning Agents leads our industry in effectively integrating commissioning and qualification to achieve regulatory compliance and project business objectives.

The result: Facilities and equipment are commissioned more quickly and with fewer problems.

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