Commissioning, Qualification, & Validation (CQV)
ProPharma has more than two decades of experience commissioning, qualifying, and validating (CQV) manufacturing facilities and processes for regulated clients.
Why is CQV Important?
Commissioning, Qualification, and Validation (CQV) are essential processes in regulated industries, ensuring compliance, product quality, and safety. They mitigate risks, maintain data integrity, improve efficiency, and support regulatory approvals. CQV also enhances reputation, saves costs, and prioritizes patient safety in healthcare.
Expert Solutions. Proven Results.
With all clients, we take a balanced, risk-based approach to deliver the most current, relevant, and value-added services and recommendations so they can achieve their regulatory compliance and quality assurance goals efficiently and effectively.
FDA & ISO Experience
We have in-depth knowledge of 21CFR Parts 210, 211, 11, & 820 and ISO13485.
Industry Standards & Best Practices
Flexible Approach
Right-Sized Solutions
We provide tailored CQV-related policies and procedures to clients at the level of equipment usage and related regulatory and business risk they need.
CQV Training & Resources
Access essential training and resources for computer system validation, compliance, and data integrity at Validation Center, a ProPharma knowledge center and resource.
Attend free webinars, enroll in online and in-person classes in the US and Europe, and download valuable templates and standard operating procedures. Validation Center offers everything you need for CQV and software quality assurance.
Meet our CQV Experts & Consultants
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Kyle Nordstrom
Vice President, Compliance & Quality Assurance
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John Ryan
Senior Director, CQV Expert
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Todd Sevier
Associate Director, CQV Expert
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Jaime Vaquer-Morales
Senior Project Manager, Cleaning Validation Expert
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TJ Stough
Senior Project Manager, Sterilization Expert
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Fred Wiles
Principal Consultant, Process Validation Expert
Customized Strategy. Globally Scaled Solutions.
With offices and compliance consultants located around the world, ProPharma offers the capability to execute CQV projects / support in different GxP areas on a global scale, creating efficiency and savings.
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