Validation Master Planning Capabilities
Kymanox caters to your specific needs to ensure your Validation Master Plan (VMP) is set up for success.
01
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.
Start Getting More Done!
02
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.
Start Getting More Done!
03
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.
Start Getting More Done!
04
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.
Start Getting More Done!
Meet our Validation Master Planning Solutions Experts
Faith Fraley
PRINCIPAL ENGINEER
Markets That Benefit from Our Validation Master Planning 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 Validation Master Planning 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.
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...