SOFTWARE-VALIDATION OF A WORDPERFECT(R) BASED INFORMATION MANAGEMENT TOOL

The writing, compiling and distribution of analytical documents was re organized and implemented on a new system. The new system controls the distribution of the documents to the respective receivers such as reg istration authorities and makes the document history fully traceable. The program consists of eight WordPerfect(R) macros (1709 lines of cod e) and of eight WordPerfect(R) merge facilities (2945 lines of code). Good Manufacturing Practice (GMP) rules require that such a system is validated. This case study reports a possible way of validating a comp uter system in order to comply with the GMP rules as well as of gainin g knowledge about the quality of the system. The emphasis is laid on t he planning, the execution and the documentation of the results of the validation. Eleven different persons worked on the validation of the new tool prior to the beginning of the productive phase. They found 77 defects and classified them into 4 levels of concern.