A Solution for a Fully Documented Program Run

Within a biostatistics department, it is required that each statistical result reported to the regulatory authorities is traceable (as per CFR21 Part 11). Hereto, it is necessary to know exactly what resources were used to produce the results. Typical resources are input data (e.g. SAS datasets, Excel files, ….) and programs (included SAS programs, macros, …). Each resource has to be identified in a unique way in order to allow exact reproduction of the reported results. Keeping manual track of the resources and reported results is a tedious and labor intensive task. The author has developed a SAS/AF application to allow end users to execute their SAS code in a documented fashion. The application is able to execute the SAS program and keep track of all resources used and all output created. The information will be stored in an Excel file referred to as the output bundle