Providing technical expertise to support our clients in the development and production of life-changing products

We understand today’s competitive manufacturing environment requires a commissioning and qualification partner that can support you from project inception through production. For the highly regulated biopharmaceutical and medical device industries, this means focusing on improving both the project budget and schedule, while ensuring all systems and equipment meet design requirements, are properly constructed and installed, and perform as intended. Our experienced team will guide you through the entire process, providing a comprehensive approach to the CQV lifecycle.

    “SSOE proved that great things can be achieved when a team is fully committed and will do what it takes to support the customer. It was the thinking outside the box approach for solutions such as developing the optimum cutover schedule by integrating all the interdependencies of the supporting equipment that made the SSOE team a second pair of eyes to the project lead.”

    Project Manager

    An Integrated Team

    SSOE’s C&Q experts function as an extension of your project team to guide you through the process from beginning to end. We understand the importance of upfront planning in avoiding potential issues during C&Q execution later in the project.

    Schedule

    Developing and maintaining an integrated schedule is vital to your project’s success. The SSOE team coordinates with your existing operations to identify planned shutdowns, vendor availability, and the interrelationships between your utilities, facilities, and process systems. We collaborate with you to develop a plan for an effective C&Q process, moving you to the production of qualified product more efficiently.

    Our C&Q Services

    Creative and innovative solutions that provide a competitive advantage. 

    Expertise in: 

    Commissioning Services

    • Commissioning plans that support the overall project schedule
    • Owner Project Requirements (OPR) and Design Reviews
    • Commissioning schedule integrated with construction
    • Participation in the RFI process
    • Pre-functional checklists and functional performance tests
    • LEED enhanced commissioning
    • Review of contractor training plans
    • Seasonal testing
    • Systems manual development
    • Final commissioning reports
    • Execution of commissioning activities to allow leveraging into qualification activities

    Qualification Support

    • User Requirement Specifications (URS) System Requirement Specifications (SRS)
    • Validation Master Plans (VMP)
    • Standard Operating Procedures (SOP)
    • Impact Assessments (IA)
    • Factory Acceptance Testing (FAT)
    • Site Acceptance Testing (SAT)
    • Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocol development and execution
    • Schedule integration 

    Have a project you’d like to discuss?