COMMISSIONING & QUALIFICATIONCQV by INTEGRAO
WHAT IS CQV?Commissioning, Qualification, & Validation
CQV is a very detailed process that requires an understanding of several disciplines: engineering, quality assurance, manufacturing and FDA and International regulatory agency compliance in order to place equipment and systems into use.
The process of Commissioning, Qualifying and Validating systems
is a complex series of events that all integrate to provide a validated (quality) product or process.
The steps involved in the process include the following:
- Define the quality target product profile (QTPP)
- Establishment of critical quality attributes (CQAs)
- Define the critical process parameters (CPPs)
- Definethe user requirement specification (URS)
- Definition of the functional design specification (FDS)
- Design The project
- Enhanced design review (EDR)
- Development of the validation master plan (VMP)
- Project construction
- Project commissioning
- Installation qualification (IQ)
- Operational qualification (OQ)
HOW DO WEEngage With You and Your Company?
- Work with your team to develop a Master Validation Plan
- Work with client project teams to define and coordinate the project schedule for the CQV activities.
- Engage in project design review activities
- Generate perspective User Requirement Specifications (URS) and Functional Requirement Specifications (FDS) for equipment and systems
- Write and execute IQ/OQ and PQ protocols for new and existing equipment, facility utilities, and manufacturing processes.
- Write up and document deviations and nonconformance and work to resolve and perform the close out efforts required until there is a resolution.
- Facility and Process Startup Support
- Automation Systems Qualification
- Computer systems qualification (GAMP)
- Process validation support
- Cleaning validation
- Shipping validation