Commissioning, Qualification, and Validation (CQV) Services
CQV Services from NEXA Delivering Value
Commissioning, qualification, and validation (CQV) services play a crucial role in ensuring quality, safety, and efficiency within highly regulated industries. Within the Life Sciences industry, these services are essential for the successful development, manufacturing, and distribution of pharmaceuticals, biologics, medical devices, diagnostic tests, and other related products.
The NEXA | EAM team provides CQV Services for leading global manufacturers and mission critical facilities across regulated industries, enabling clients to uphold regulatory compliance, improve operational performance, and ultimately deliver safe and high-quality products to their customers. NEXA’s CQV offerings include commissioning and qualification of new manufacturing and laboratory facilities, modifications to existing facilities and manufacturing lines, regulatory inspections and remediations, and the qualification of a wide variety of equipment, analytical instruments, and computerized systems.
Minimize Risk + Ensure Quality Standards with NEXA CQV Services
The goal of NEXA’s CQV team is to meet diverse client needs by offering an extensive range of solutions and support. As patient safety is of paramount importance in the Life Sciences industry, NEXA’s CQV services help identify potential risks and ensure that systems and equipment are properly designed, installed, and operational. This includes qualifying the functionality of critical systems, such as HVAC systems, cleanrooms, and manufacturing equipment, to ensure that they adhere to design requirements, regulatory requirements, and industry best practice. By working with NEXA to implement rigorous CQV procedures, clients can minimize the risk of product contamination, equipment malfunctions, and other hazards that could compromise patient safety.
Whether it involves CQV consultancy, project management, process engineering, quality assurance, or other offerings, NEXA employs a seamless and cohesive approach to deliver a unified solution to address each client's unique requirements.
NEXA | EAM CQV services include:
- Commissioning & Qualification of Facilities, Utilities and Equipment
- Process Engineering & Facilities Engineering
- Quality Engineering (QE) & Quality Assurance Validation (QAV)
- Project Management
- Manufacturing Process Validation
- Cleaning Validation
- Sterilization and Depyrogenation Validation
- Cycle Development for Cleaning & Sterilization Processes
- Shipping/Supply Chain Validation
- Computer Systems Validation (CSV)
- 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
By thoroughly qualifying equipment and validating critical processes, clients can identify and rectify inefficiencies or bottlenecks that may hinder productivity. This includes writing user requirement specifications, executing equipment performance testing, and implementing robust process controls to ensure that systems and processes continue to operate in their qualified state. CQV services from NEXA | EAM help streamline operations, reduce downtime, and improve overall productivity.
The NEXA CQV team welcomes the opportunity to learn about your specific requirements and work closely with you to tailor a strategy that facilitates a thorough assessment of your Commissioning, Qualification, and Validation processes.