Lab & Equipment CQV Capabilities
The Kymanox team will help you assess and plan for your specific lab & manufacturing equipment Commissioning, Qualification, and Validation (CQV) needs.
01
FAT/SAT Support
Accepting custom equipment after completing a Factory and/or Site Acceptance Test (FAT/SAT) can be time consuming and resource intensive. Kymanox helps streamline the process with “Right First Time” execution.
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02
Unsurpassed Validation Experience
Our team has years of technical experience across a broad range of commissioning, qualification, and validation projects. This expertise, combined with our quality focus, enable us to tackle and CQV project.
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03
Integrated Approach
Kymanox ensures efficient and successful qualification by providing engineering and regulatory resources, using an integrated team approach, and providing a single-point of contact technical project manager.
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04
Safety Comes First
Safety is always our first priority. All work is supervised by appropriately qualified personnel and we take pride in our excellent safety record.
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Meet our Lab & Equipment CQV Solutions Experts
Faith Fraley
PRINCIPAL ENGINEER
Markets That Benefit from Our Lab & Equipment CQV Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
The Kymanox Difference
At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.
"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
Proven Broad Expertise
Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.
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.
Frequently Asked Lab & Equipment CQV Questions (FAQs)
What lab and equipment systems can Kymanox validate?
Kymanox has deep experience across a wide range of GMP systems, including cleanrooms, utilities, aseptic manufacturing equipment, packaging equipment, controlled storage equipment and facilities, computerized software systems, building management systems (BMS), and environmental monitoring systems (EMS).
Read the Latest at Kymanox
The Factor Podcast: Winning Formula to Navigate Combination Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that collects her years of industry experience into a compr...
The Factor Podcast: Transforming Nursing Through Innovation and The Evolving Role of Nurses in Advancing Patient-Centered Care
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, we speak with industry leader, Dr. Bonnie Clipper, to discuss innovations in technologies to empower nurses and improve patient care. Dr. Bonnie C...
The Factor Podcast: Exploring EUDAMED Requirements for EU MDR
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this informative episode of The Factor, we sit down with industry experts, Dr. Christiana Hofmann and Richard Houlihan, to discuss EU MDR's implementa...