Documentation and Validation of a User Writer Program

This article discusses the procedure used to validate the data reduction program, ASSAY, currently being used by DuPont Pharmaceuticals in analytical research and development. ASSAY is a FORTRAN 77 program (written in-house) that runs on Hewlett-Packard (HP) 3357 system (HP1000 E-processor operating under RTE-VI). The assay program retrieves raw and processed chromatographic data files for reprocessing, statistical analysis, and calculation of assay values; it also outputs standard and sample chromatograms, a copy of the analytical method, and calibration curves for inclusion in a lab notebook). This article discusses the organization of documentation (flow charts, standard operating procedures manuals, software logs) and the validation process (automation, test data files, module testing and debugging, determination of acceptable limits and operation limits). Ongoing validation and security will also be covered.