INFORMATION TECHNOLOGY LABORATORY INFORMATION MANAGEMENT-SYSTEMS - PROBLEMS OF REGULATORY COMPLIANCE

Despite the attention paid to the regulatory requirements for computer systems, recent inspections continue to report basic failings in the standards of validation and documentation. This paper describes the need for validation of vendor-supplied software such as Laboratory Information Management Systems and the procedures necessary for control of the production phase in a regulated environment. Whereas these requirements may be considered ''good computing practices,'' their adherence remains a management challenge at odds with pressures of cost, business need, and time.