Tuesday, May 5, 2009

Validation of the SAS System

Validating a new version of SAS on a production server used to be a daunting task. The SAS System version 9.1.3 and 9.2 ships with user friendly installation qualification tools. This is coupled with existing tools that make it easier to validate SAS. Besides qualifying the installation, 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 and programming practices.

The interconnectedness of the SAS computing environment does require considerable efforts in validating a SAS System. However, if this is executed successfully, it can allow for greater traceability between output, programs and source data. The performance qualification also sheds light on ways of optimizing the work and data flow of your computing environment. The many benefits of performing validation of the SAS System will outweigh the costs. In addition, it is a requirement within a regulated environment so it is recommended to be prepared.

Validation Overview
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 paper include migrating from SAS 8.2 to SAS 9.1.3 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 zoom in on individual components. This allows you to access the scope and interconnectedness of each component so that your validation efforts are balanced and thorough. Once the architecture is clearly understood, the requirements and functional specifications of each component are documented. These functional specifications then drive the validation testing.
It is important to follow these steps in a systematic and orderly fashion since they are interdependent. Documentation of each step in the validation process is also essential in capturing and proving that the validation effort was done properly. Besides documenting each step, it is also important to capture the traceability of each validation task. 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 make the difference between a successful validation audit and a complete failure.

The main goal of the validation effort is to ensure that the installation and implementation of the SAS system and its associated tools function as intended by the vendor (SAS Institute) and your organization. The validation will ensure this success. In addition to this goal, the documentation of your validation effort will also ensure the integrity of your computing environment and be in compliance with regulatory requirements such as the CFR Part 11 within the biotechnology and pharmaceutical industry.

System Components
The first step in your validation effort is to understand what it is that you are working with. The SAS System, as delivered to you in a series of CDs, is a system which contains modules such as Base, Stat, Graph and other components of SAS. This however only makes up part of the system that you are implementing in your organization. The SAS software fits into a computing environment that interacts with other software and hardware. If you were to take into account all the associated hardware and software that SAS interacts with, this is what is considered the “SAS System” from a validation perspective. It is therefore important for you to take the right steps to identifying and documenting all these components.

Step 1: Identify all the hardware components of your computing environment. For example:

Hardware Component

Name

SAS Application Server

SASAPPSRV

SAS File Server

SASFILESRV

Client Desktops

CLIENTDSK


complete paper at "Validating Your SAS System " and related SAS Validation...


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