CQV Process
Commissioning, Qualification, & Validation
Lower Risks While Increasing Productivity: Discover CQV Services from Transcat
Ready to improve the way you work? Transcat can help organizations streamline operations, reduce downtime, and improve overall productivity. Learn how our expert teams thoroughly qualify equipment and validate your critical processes to identify and correct inefficiencies that inhibit productivity.
Transcat can help you write user requirement specifications, execute equipment performance testing, and implement process controls to ensure that systems and processes continue to operate in their qualified state.
Partnering with Transcat: What to Expect From Our CQV Services
While our solutions are complex – just like your business needs – we make partnering with us simple and easy. Learn how our CQV Process supports productivity and efficiency and explore what the CQV implementation process may look like for you.
Step One: Understanding Your Needs
The first step to implementing a CQV process is to define the project’s scope. Our team will work with you to:
- Gain a comprehensive understanding of your organization’s systems and processes, defining goals, requirements, and specifications
- Identify potential hazards
- Perform assessments (Failure Mode and Effect Analysis (FMEA), cGxP, Data Integrity, 21 CFR Part 11, etc.) that the equipment will be tested against
- Define critical project requirements, such as adhering to industry-specific FDA regulations and other compliance requirements
- Clearly define your budget, timeline, and expectations
Our knowledge and experience will help to ensure a seamless and cohesive delivery of a unified solution that addresses your unique requirements.
Step Two: Choosing the Right Experts for Your Project
Implementing effective CQV services requires deep knowledge and experience. Transcat’s CQV Team will identify subject matter experts (SMEs) specific to your industry who can make recommendations on equipment, software lifecycle, and FDA Regulations in order to help your project succeed. These experts may include a validation engineer, project manager, general construction liaison or contractor, and a quality assurance lead to oversee the CQV process.
Step Three: Developing an Effective Master Validation Plan (MVP)
Once goals, challenges, and objectives have been identified, we will build your roadmap for CQV implementation: your Master Validation Plan. This comprehensive document includes:
- An overview of your planned validation strategy
- Key roles and responsibilities
- Your budget and timeline for implementation
- Risk assessment procedures
- Testing and acceptance criteria
- An overview of how services will be delivered, tested, and tracked
Step Four: Commissioning
Implementation of your CQV process begins with installation (overseen by our team), ensuring operation and safe functioning of your system, and ensuring all user requirements are met prior to moving to qualification.
Goals of the Commissioning stage:
- Protect the equipment before placing into service
- Ensure seamless execution of qualification protocols
- Properly document any issues encountered during testing and determine an effective and compliant resolution
Step Five: Equipment Qualification
This important step ensures that finished goods are delivered under repeatable parameters. Here’s how:
- Design Qualification (DQ): Document verification that the design of the new equipment will result in a system suitable for the intended use
- Installation Qualification (IQ): Confirmation that the equipment is installed correctly and verifies the design specifications
- Operational Qualification (OQ): Ensures the machine operates per functional specifications.
- Performance Qualification (PQ): confirms that the equipment consistently performs to user specifications in production situations
Step Six: Validation
During Process Validation, our team supplies documented evidence that the new processes can consistently produce finished goods that meet the defined quality specifications. This is a multi-step process requiring revalidations and periodic reviews to ensure that the system remains compliant and is not trending out of specification.
Also critical to success in the Validation process is ensuring that each product produced consistently meets specifications – also called Process Validation (PV) protocols. This is an essential FDA requirement, and efficiently managing this process helps to ensure compliance. This is the final step in qualification before the release of your equipment for use.
Step Seven: Continued Process Verification
Once your facility has been validated per the MVP defined at the start of the project, our team will turn their focus to Continued Process Verification (CPV): ensuring that the process remains controlled during production. They’ll perform continued assessments of the parameters and attributes within the control strategy as defined in your MVP.
Step Eight: Maintaining Compliance
Finally, in order to maintain compliance with FDA Regulations, the team will regularly review and audit your validation protocols and processes to confirm compliance. This is especially important if changes are made to the systems or process.
Get Started
We make getting started with CQV services easy. Contact us to request a quote today, and our team will reach out to you to learn more.
