Implementing CFR 21 part 11 for SAS® without tears or joins

Abstract

Abstract This paper argues that the best way to construct an easy-to-program in and CFR 21 part 11 compliant environment for SAS® programming is by using a version control system, specifically the IBM Rational product ClearCase®. It concentrates on architectural issues to do with protecting data and outputs as well as programs, and stresses the importance of linking an output with its constituent parts. The main reasons for using ClearCase® are explained and illustrated with examples from a successful implementation. Enough information about ClearCase® is included to show why it is uniquely suited, among all Source Code Management Systems, for this task. Although this paper focuses on SAS®, the environment can also be used for other programs with little or no changes.