CQV Services
CQV Services | Commissioning, Qualification, and Validation for Life Science Industries
Our Commissioning, Qualification, and Validation (CQV) team is equipped with the expertise to deliver a range of services, including assisting with new facility start-ups, implementing modifications to existing facilities and equipment, supporting regulatory inspections and submissions, responses to regulatory inspection observations, and remediations.
​
At every stage of a project, we bring top-tier expertise to the table.
​
The goal of our CQV team is to meet the diverse needs of our clients by offering an extensive range of solutions and support. Whether it involves consultancy, project management, process engineering, quality assurance, or other offerings, we employ a seamless and cohesive approach to deliver a unified solution that addresses each client's unique requirements.
​
Our services include:
-
Equipment Commissioning & Qualification
-
Process Engineering & Facilities Engineering
-
Quality Engineering (QE), Quality Assurance (QA), and Quality Assurance Validation (QAV) Consulting
-
Project Management
-
Manufacturing Process Validation
-
Cycle Development for Cleaning & Sterilization Processes
-
Shipping/Supply Chain Validation
-
Laboratory Equipment/Analytical Instrumentation Validation
-
Validation Master Plans, Project Plans, Protocols, Reports & SOPs
-
Consent Decree & FDA 483 Remediations
-
Regulatory Submissions and Inspections: USFDA, EMEA, TGA
Employing decades of experience across highly technical industries, our team is prepared to ensure your success. By integrating SteriQual into NEXA and harnessing the expertise of Transcat, our clients across all regulated industries receive the benefits of a synergistic team that brings together diverse skills and knowledge and can deliver a comprehensive range of services from a single source.
​
We welcome the opportunity to learn about your specific requirements and will work closely with you to tailor a strategy that facilitates a thorough assessment of your Commissioning, Qualification, and Validation processes.
Partnering with us unlocks the potential for optimizing manufacturing efficiencies in your operations.
Contact our team for a consultation to discuss your Commissioning, Qualification, and Validation needs.