Purpose :: SAS(R) Clinical Standards Toolkit 1.5: Operational Qualification

Starting with the SAS Clinical Standards Toolkit 1.5, an internal validation process is provided. This process has been designed using tools and metadata already available with the product. In other words, the SAS Clinical Standards Toolkit is set up as a standard within the product and is validated against a set of reference metadata.

The SAS Clinical Standards Toolkit internal validation addresses two primary use cases:

Perform installation qualification and operational qualification.

This is implemented with and illustrated by the use of the validate_iqoq sample driver, located in the sample study library directory/cst-framework-1.5/programs folder. This is a two-step process.
1. Select the CST-FRAMEWORK standard, and run the checks that are defined in the validation_control_glmeta view of the internal validation validation_master data set. This is a set of 64 checks (checkid < CSTV100) that look only at the global standards library metadata folder.
2. Select 1 to n specific standards, and run the checks that are defined in the validation_control_stdiqoq view of the internal validation validation_master data set. This is a set of 30 checks (checkid > CSTV100 that are relevant to installation qualification and operational qualification issues) that look only at metadata libraries other than the global standards library metadata folder.
Perform validation on standard-specific metadata.

This is implemented with and illustrated by the use of the validate_standard sample driver. Select 1 to n specific standards, and run the checks that are defined in the validation_control_std view of the internal validation validation_master data set.

This is a set of 39 checks (checkid > CSTV100) that look only at metadata libraries other than the global standards library metadata folder.

For the purpose of operational qualification, this document implements the SAS Clinical Standards Toolkit internal validation for installation qualification and operational qualification.

For more information about internal validation, see Chapter 7, “Internal Validation,” in the SAS Clinical Standards Toolkit: User’s Guide.

This document explains how to verify that the SAS Clinical Standards Toolkit 1.5 has been installed correctly and is operating properly. The installation is tested by running a series of SAS Clinical Standards Toolkit internal validation programs. These programs must be run in the sequence that they are presented. In addition to the internal validation process, a separate process enables you to manually run driver programs to verify that the product is operating correctly.