Laboratory Equipment Qualification Process

PROJECT OVERVIEW
CAI assisted a global healthcare company in Chicago, Illinois with upgrading their laboratory for a new product release. The project involved determining necessary laboratory equipment, providing resources for equipment qualification and creating operational and maintenance procedures. CAI’s team assessed required testing for in-process and final release, determined appropriate equipment types and precision and managed the project from start to finish. Their expertise in laboratory equipment and regulatory standards for validation and testing was crucial in generating appropriate documentation, coordinating deliverables and executing the project on time and within budget.
Topics covered
- Laboratory equipment selection and qualification
- Regulatory compliance in laboratory operations
- Project management for laboratory upgrades
- Equipment user requirement specifications development
- Qualification protocols and reports creation
- Operational and maintenance SOP generation
- Methods validation according to ICH Q2 (R1) and USP regulations