A Model for an End User Computer Validation Control System in a Research Laboratory Environment

Documented evidence for the purported performance of a computer system or program is a requirement for pharmaceutical research laboratories. Most models for computer validation follow those outlined for a system development life cycle. In a research laboratory environment, however, computer programs are often purchased after the development cycle is completed. A model has been developed that is more appropriate for documenting and maintaining validation of computer systems by end users. Validation requirements for testing, documentation, and management are specified by a standard operating procedure (SOP). Testing objectives and procedures, a description of the hardware and software system, functional specifications, and any known limitations are outlined in a validation test protocol. Testing results are summarized in a research report and any additional limitations or operational procedures required for maintaining the system in a validated state are also included in the report. Operational procedures may be added, deleted, or modified as needed. All documents are filed in databooks that are maintained in a validation library. The compilation of test plan, hardware/software description, system limitations, operational procedures, and system management is called a validation control system.