Basic Information

Session Title: Analytical Instrument Qualification for Systems Utilizing Multi-Vendor Components

Facilitator Name:Christopher Hahn
Affiliation:CSols, Inc.

Date: Wednesday, March 8, 2017
Start Time: 10:30 AM
Location: W185bc


Modern labs have increasing amounts of computerized analytical instrumentation, highly comprised of components from more than one manufacturer. There are no specific regulatory requirements or industry guidelines that address instrument qualification and software validation of such multi-vendor systems. Typically, vendors execute their standardized IQ/OQ protocols leaving the onus on the customer to assemble well-organized, comprehensive and inspection ready PQ packages which cover the systems intended use. These PQ packages require time-consuming, customer specific, user requirements testing to ensure that the various components perform together as a single “system.” Join us for this open forum session to learn the various ways other organizations have handled such complex systems.