Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements

By R. D. McDowall

Glossary

Acceptance criteria: The criteria a system must meet to satisfy a test or other requirement (FDA Technical Report 18)

Boundary value: A minimum or maximum input, output or internal data value, applicable to a system (PDA Technical Report No. 18)
Branch testing: Execution of tests to assure that every branch alternative has been exercised at least once

Change control: A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status to determine the need for corrective action that would assure that the system retains its validated state
COTS Software: Commercial off the shelf software applications that are used as is or can be configured to specific user applications by filling in the blanks without altering the basic program
Commissioning: Activities to put a computerised system into proper operation
Computer hardware: Various hardware components in the computer system, including the central processing unit, printer, screen and other related apparatus
Computer system: Computer hardware components assembled to perform in conjunction with a set of programs, which are collectively designed to perform a specific function or group of functions
Computer related system: One or more computerised systems and the relevant operating environment
Computerised system validation: Establishing documented evidence which provides a high degree of assurance that a specific computer related system will consistently operate in accordance with predetermined specifications
Computerised system: A computer system plus the controlled function which it operates
Computerised system specification: A document or...

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Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements