Process Validation Capabilities
At Kymanox, our team of process validation experts can help meet your specific needs with fit-for-purpose solutions.
01
Process Validation Life Cycle
We look at process validation as a lifecycle and follow FDA guidance which presents process validation in 3 phases: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification.
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02
Depth of Expertise
Our broad experience ensures analytical methods are validated to support process development and control. Our qualification experience extends to equipment, facilities, and utilities also.
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03
Integrated Team Approach
Keeping all aspects of process validation on track requires a combination of engineering, project management, and regulatory expertise. Kymanox excels in these cross-functional projects.
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04
Regulatory Focus
Kymanox stays up to date with the regulations issued by governmental agencies and industry guidance issued by both governmental and non-governmental bodies (e.g., ISPE, ISO, ICH, WHO).
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Meet our Process Validation Solution Experts
Nicole Bridgers
PRINCIPAL PROCESS ENGINEER
Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Process Validation 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 Process Validation Questions (FAQs)
Why is a control scheme necessary?
A well-defined control scheme must be developed to ensure the process consistently produces quality product(s). The process must be well-characterized to assist with developing an appropriate sampling plan that produces data that is statistically significant during PPQ.
Does Kymanox follow GAMP guidance?
Whether the focus is on implementing automation into already functioning systems, or purchasing new equipment or systems utilizing automation, Kymanox leverages the Good Automated Manufacturing Practices (GAMP) guidance approach which defines a set of industry best practices to enable compliance to all current regulatory expectations, leveraging your company’s current quality procedures. For this reason, it can be tailored to a number of computer system types without significant impact to current equipment and systems.
We work in concert with users and suppliers so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance, known as User Requirement Specifications (URS) and Functional Requirement Specifications (FRS), that a system is appropriate for the intended use before it goes “live.” We can also ensure that suppliers use GAMP methodologies to test for avoidable defects in the supplied system to ensure quality product leaves the facility. For example, ISPE’s GAMP V-model is fully leveraged and all validations are based on approved, testable requirements.
Read the Latest at Kymanox
The Factor Podcast: Navigating the Real-World Environment of Medical Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into hea...
The Factor Podcast: Factors to Consider in Support of Clinical Readiness
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of har...
The Factor Podcast: The Role of Human Factors in Medical Product Development
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combinatio...