Commissioning and Qualification

Commissioning and Qualification

Azzur's engineering experts are committed to helping clients start up or renovate their facility, utilities, systems, and equipment (FUSE) through our commissioning and qualification (C&Q) services. We strive to provide cost-effective solutions in a timely manner. Our streamlined engineering practices use a risk-based approach.

At Azzur, our goal is to understand the unique requirements of your process and product and to build a plan focused on the associated critical aspects while maintaining regulatory compliance.   Our subject matter experts (SMEs) are backed by real-world experience and the technical skills to help make your project a success.
 

Our Credentials:


Our C&Q project experience spans the pharmaceutical, biotechnology and medical device industries and includes products that utilize various platforms and at various phases of their product lifecycle. Azzur's SMEs have C&Q experience with facilities, utility systems, support equipment, process equipment, analytical instrument, cleaning processes, and sanitization/sterilization processes.
 

Our C&Q services include:

 

Installation & Start-Up Commissioning


●    Design Reviews
●    Factory Acceptance Tests (FATs)
●    Receipt and Inspection
●    Site Acceptance Testing (SAT)
●    Commissioning Protocol/Checklists
●    Punchlist Management
 

Verification/Qualification and Validation


●    User Requirement Specifications
●    Function Requirement Specifications
●    Detailed Design Specifications
●    Critical Aspect Risk Assessments
●    Facility Validation Master Plans
●    Installation Verification/Qualification
●    Operational Verification/Qualification
●    Cleaning/Steaming Cycle Development
●    Performance Verification/Qualification
●    Cleaning Validation
●    SOP Generation
●    Change Control Assessments
●    Deviation/Investigation Management