Validation Master Planning Capabilities
Kymanox caters to your specific needs to ensure your Validation Master Plan (VMP) is set up for success.
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!
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!
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!
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
Markets That Benefit from Our Validation Master Planning Solutions
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
Nathan Blazei Joins Kymanox as Head of Quality
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How the FDA Defines Combination Products
Is your product a combination product? Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products. The FDA identifies.Ta...