Commissioning & Qualification
Commissioning & Qualification of systems ensures reliable operation and regulatory compliance of facility and equipment, to ensure product end quality and traceability.
We design with C&Q in mind and we ensure integration is integral to turn key success, we risk assess at commissioning stage and address the critical path items up front.
We develop and execute the following qualification documentation depending on client project requirements.
⦁ User Requirements
⦁ Functions Requirements
⦁ Design Requirements
⦁ Hardware Requirements
⦁ P&ID Qualification Requirements
⦁ Commissioning and Qualification plans
⦁ Commissioning and Qualification Protocols
⦁ Validation Plans and Protocols (in line with site VMP)
⦁ Factory Acceptance Tests (FAT)
⦁ Site Acceptance Tests (SAT)
⦁ Installation and Operation protocols
⦁ Performance Qualification
We provide a combination of the above documentation to cater for the client’s project needs or we can execute the clients protocols depending on the clients requirements.
Our activities are guided by standards such as ISO 14644 and ASTM-E2500, 21 CFR part 11 and CSV guidelines.
We also provide guidance and assistance on:
⦁ Process & Equipment Validation
⦁ Sampling Locations maps
⦁ Risk Analysis
⦁ Cleanroom Monitoring, Class and Limits
We are not a body shop, but we do offer resource management on large scale projects for the client, this can remove the burden of the client in dealing with vendor documentation approvals and execution competency, we also provide resources to deal client critical path approvals and project management of C&Q packages o client handover stage.