ABSTRACT
Computers are widely used in analytical laboratories for instrument control, data evaluation, and data management, and are subject to all validation and verification activities. Verification and validation activities to assess computer systems used in analytical laboratories cover all life-cycle phases, from user Requirements Specifications, design, development, and manufacturing to installation and operation. In this case study, users of computer systems will find guidelines on:
• How to define user requirements and Functional Specifications (FSs) • Which type of documented evidence the vendor should provide to prove that the system
was developed according to recognized standards • How to validate and document software developed in the user’s own laboratory • How to proceed in cases where vendors do not give evidence of validation • How to qualify a computer system at installation and for operation • How to evaluate computer systems in analytical laboratories retrospectively • How to ensure an ongoing performance control during routine analysis
This case study does not cover verification activities during development at the vendor’s site. This is described elsewhere.1
