Commissioning, Qualification, & Validation (CQV)

Commissioning, Qualification, & Validation of systems supporting drug production processes are crucial for patient safety, product quality, and regulatory compliance.

Kymanox's Subject Matter Experts (SMEs) collaborate with clients to ensure efficient and successful CQV processes, from user requirements to operations handover. Key practice areas are all encompassing and include facilities, utilities, cleanrooms, equipment, processes, cleaning, computer systems, and environmental chambers.

Skilled services in the following:

  • Validation Master Planning (VMP)
  • Lab & Equipment Assessments
  • Gap Assessments & Remediation Programs
  • Design Qualification
  • Commissioning, Factory Acceptance Tests (FAT)
  • Site Acceptance Tests (SAT)
  • Installation & Operational Qualification
  • Validation Master Planning Capabilities

    Kymanox® caters to your specific needs to ensure your Validation Master Plan (VMP) is set up for success.

    Integrated Perspective

    Creating a VMP requires a combination of engineering, project management, and regulatory expertise. By using an integrated team of experts, Kymanox will save you time and create a clear path to your goal.
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    Holistic Approach  

    By understanding the bigger picture, our experts can find the correct, phase-appropriate solution for your process. Our clear understanding of the regulatory landscape will save you effort bringing your process into compliance.
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    Continuous Improvement

    Our experts can help you identify weaknesses in your program and create the documents needed to address them. Ask about our validation gap assessments and remediation for your program.
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    Proven Track Record 

    We have a proven track record in developing customized Process Validation Master Plans from stage 1 development, through Process Qualification to Continued Process Verification.
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    Voice of the Customer

    "Kymanox provides us great support"
    "Kymanox provides a very high value."
    "They understand my needs."

    Frequently Asked Questions (FAQS)

    Why is there so much documentation involved with Validation?
    Proper documentation is required to capture the planning, requirements, testing, and quality approvals associated with a system.  Without documented evidence, there is no proof that a system was evaluated and qualified appropriately.  Gaps in documentation can reflect gaps in control.  On the bright side, the level of documentation should be appropriate for the system.  If a system has low impact to the quality of the product or patient impact, the level of documentation should reflect that.  For example, a formal risk assessment may not be necessary and risks can therefore be discussed elsewhere such as in the Validation Plan or associated protocol. 
    How can I maintain the validated state of my facility/utilities?
    After qualification, it is important to maintain the validated state throughout the life cycle of your equipment. There are many reasons why equipment/systems can no longer maintain a validated state (breakdowns, modifications, aging, regulatory updates, introduction of new product, etc). Therefore, the best place to start is with a strategic and comprehensive gap assessment prioritizing upgrades and replacements as needed. At Kymanox, we can assist you with a variety of solutions (performing periodic reviews, revalidation, establishing a robust change management system, etc) to ensure your facility maintains its validated state and meets regulatory compliance.  
    What is the purpose of CQV?
    Commissioning, Qualification, and Validation (CQV) is an essential area for the life science industry. Commissioning and qualification of systems that support the drug production process (facilities, utilities, and equipment) is critical to ensure patient safety, product quality, regulatory compliance, and business needs. Our SMEs will work together with you to ensure an efficient and successful CQV process from the early stages of user requirements to operations handover. Throughout the process, Kymanox will continuously educate your team to enable knowledge transfer and ensure sustainability.  Whether you are a small start-up or commercial manufacturing company, Kymanox is ready to assist you with any of facility, utility, and equipment needs.