| Publisher | SAS Institute | ||
|---|---|---|---|
| Format | 35.6KB PDF | Date added | 28 Feb 2006 |
| Topics | Virtualization | ||
| Downloads | 135 | ||
21 CFR Part 11 states that computer systems used in the clinical trials process must adhere to certain criteria, one of which is validation. The Computer Systems Validation (CSV) paradigm exists to provide guidance and structure to this process. Within the SAS programming environment, there is a lot of debate on how to approach validation, both of the SAS programming environment itself, and the applications that get created. There often are contentious viewpoints. The CSV model calls for separate areas for development, testing, and production to ensure that there is an orderly, documented path to the development of SAS programs and enhancements to the SAS infrastructure itself. This paper examines how virtualization of systems can play a role in adhering to CSV principles for SAS systems.
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