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SAS System and SAS Program Validation Techniques

This course will teach methodologies of performing SAS system and SAS program validation including new installations and updating to a new version of SAS on a production server including SAS macros and programs. Some of the topics covered include: backward compatibility, SAS systems versus multi-use SAS macros, project specific and stand alone SAS programs and standard programs for portability. Validation of a SAS system most commonly occurs during an upgrade from an older version of SAS or moving to a new platform. The examples used in this course include migrating to SAS 9.2 and moving from a legacy operating system to the windows platform. In either case, similar validation challenges are confronted. It is recommended that you first acquire a global view of the system and identify the architecture. Only after gaining this perspective would it be useful to then focus in on individual components. This allows you to obtain the scope and interconnectedness of each component so that your validation efforts are balanced and thorough. Once the system architecture is clearly understood, the requirements and functional specifications of each component are documented accordingly. These functional specifications then drive the validation testing. INTRODUCTION Validating a new version of SAS on a production server or a series of standard macros can be daunting task. The SAS System ships with user friendly installation qualification tools can assist in this process. This tool coupled with other tools and a well defined process makes it a little easier. Besides qualifying the installation and implementation, there are other tasks and components of the system that need to be validated or verified. Some of these components include: 1. Backward compatibility issues with older versions of datasets and format catalogs. 2. Validating multi use macros and standardized code templates. 3. Verifying stand alone or project specific programming and output. 4. Effects on Standard Operating Procedures (SOP) and programming practices. The interconnectedness of the SAS computing environment does require considerable efforts in validating any addition or changes to the current environment. If the validation is executed successfully however, it can ensure that the new system has greater traceability between output, programs and source data. The performance qualification also sheds light on ways of optimizing the work and dataflow of your entire computing environment. The many benefits of performing validation of the SAS System will outweigh the effort and associated costs. In addition, validated systems are required within a regulated environment so it beneficial internally and when interfacing with an external collaborators or regulatory agencies. It is important to follow validation steps in a systematic and orderly fashion since they are interdependent. Documentation of each step for instance, in the validation process is also essential in capturing and proving that the validation effort was done properly. Along with detail documentation, the capture the traceability of each validation task is essential for the reviewer. For each test case that is performed, there is an associated functional specification which then is connected to the requirements for a particular component of the system as a whole. The map or traceability matrix that ties all these validation components together is pivotal to an auditor. Proper documentation will therefore make the difference between a successful validation audit and a complete failure. One of the main goals of the validation effort is to ensure that the installation and implementation of the SAS system and tools function as intended by the vendor (SAS Institute) or the author of the macro and your organization. The validation will ensure this success of this process. An example work flow for a validation process is shown below in this diagram.