Application software configuration management testing in a pharmaceutical laboratory automation environment

A discussion is presented of the use of the computer system accounting structure to control software change, provide phased software testing, and handle software and data files in parallel with the software life-cycle. The US Food and Drug Administration, as the federal regulating body for the industry, directly influences software maintenance practices and procedures. Traceability to back versions of the software, as well as software validation, is required. Three categories of testing are discussed: systems testing (for designed functionality), user acceptance testing (for validation), and verification testing (for consistent operation). Testing is introduced into the life cycle according to established procedures. Software and data integrity is ensured throughout the life cycle through strictly controlled user access and file management using the operating system accounting structure