Quality Assurance Capabilities

At Kymanox®, we provide end-to-end quality and compliance solutions for all stages of your product’s life cycle. Our quality assurance team utilizes a risk-based, patient-centric approach and partners with you to commercialize modern drug/biologic products, medical devices, and combination products.

Quality Management Systems

The quality team at Kymanox offers risk-based support for Quality Management Systems (QMS) and electronic QMS (eQMS) design, implementation, maintenance, and streamlining. Kymanox has extensive experience working with clients to ensure their QMS is current and compliant with all applicable industry standards. We can conduct a review of your current QMS against 21 CFR Parts 4, 210, 211, and 820 and identify gaps, select and implement a QMS that fits your company’s needs, or author and/or review documentation.
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Quality Engineering

Kymanox experts analyze data and develop the necessary documentation to support your product through development, product launch, and life cycle management. Our team can help ensure quality and compliance in your manufacturing process by conducting operations data trending and statistical analyses, using Six Sigma and Lean Manufacturing principles for product and process improvement, evaluating equipment/process capability, implementing Statistical Process Control (SPC), authoring periodic process monitoring reports, and supporting Continuous Process Verification (CPV).
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Risk Management Files and Design History Files

The Kymanox quality team works closely with the Device Development and Commercialization (DD&C) team to author and/or update risk management documentation including Risk Management Files (RMF) and Design History Files (DHF) to support marketing authorization approval.
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Other Areas of Expertise

Kymanox can support other quality activities, including, but not limited to: supplier qualification, implementing, training programs, and quality improvement tool implementation and oversight.
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The Kymanox Quality Assurance Difference

Kymanox delivers “Right First Time” results with the critical thinking and practical experience needed to meet regulators expectations.
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Experience + Approach

We have experience with novel, high-risk, complex products (e.g., biologic with multi-use auto-injector). This experience informs our risk-based approach to personalized support.
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Flexibility & Agility

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
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Right-Sized Solutions

Kymanox prides itself on creating right-sized solutions for our clients based on their specific needs. We will help you avoid the hassle and cost of complex systems that may seem like a foolproof choice.
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Frequently Asked Questions (FAQs)

What is the greatest pitfall today during risk management activities?
Following ICH Q9 Quality Risk Management for drugs is no longer enough. More and more drug products now are categorized as combination products, and the definitions of requirements have changed significantly.  The old ways of doing things don’t work anymore. The FDA has adopted a proactive, holistic approach to identifying and removing risks before they are realized, instead of focusing on the process for handling risks once they are identified. 
Measuring Risk is about potential lost product, right?
Today you can no longer link your risk management tools to lost product or rejection of material, nor can you use economic considerations in the justification of enacting risk controls!!  Risk is measured by severity of the harm to the user and patient, and the frequency that the harm will occur. In the past, severity could be based in a manufacturing framework, where the highest severity was “results in rejection of multiple batches or recall of lots on the market.”  This speaks to an inherent business risk.  In the combination product space now, you have to consider the harm to the user and/or the patient, which drives the risk reduction priorities. 
I have a product in early development, and I am considering a different platform device for my drug product, do I need to implement design controls and risk management now?
Yes! It is critical to begin the documentation of your user needs with your specific intended use (i.e. emergency use device, prophylaxis, etc.).  The first step to every good project is a plan, and design controls and risk management are no different.  A Design and Development Plan and a Risk Management Plan will ensure your device selection process is well defined with objective criteria, that your user needs are defined, and the correct requirements are laid out in the development process. 
Do design controls and combination product development processes end at product launch?
No, design controls and life cycle management are a living system that stay with the product throughout its entire lifecycle. Design History Files are living documents that are started in clinical development, and maintained until the product is retired from the market.  Every change control requires an evaluation against the design of the product.  
What are the high level elements of risk management?
Risk management includes the identification, evaluation, and control of hazards and harms to a user or patient that are associated with the use of a product.  Risk is the combination of the severity of the harm and the potential occurrence of the harm.  Risks pertains to the use of the product, the design of the product, and the processes by which the product are manufactured.  All risks must be controlled and reduced as low as reasonably practicable, and all residual risks associated with the product must be weighed against the clinical benefits of the product, and must be signed off by someone with the clinical competency to assess both the risks and benefits of the product. 
How can we mitigate risks with on-site visits for our third-party vendors when travel conditions are suboptimal?
Kymanox offers virtual audits! We're able to reduce risk and continue quality oversight of your GxP service providers remotely. Virtual tours may be conducted of manufacturing areas, testing laboratories, and warehousing/distribution sites.  Through our online interface, we're able to conduct personnel interviews and review documentation. Our clients are even able to participate in our virtual audits by simply logging in to our online meeting platform.