An integrated risk assessment for analytical instruments and computerized laboratory systems

In this column we have presented a comprehensive risk assessment process for classifying apparatus, instruments, and computerized laboratory systems used in regulated laboratories. The intention is to demonstrate clearly that an integrated approach to analytical instrument qualification and, where appropriate, computerized system validation, is more efficient than separating the two tasks. The risk assessment also ensures that laboratories qualify or validate all intended use functions in an item and aims to minimize regulatory exposure from omitting work.