SAS System and SAS Program Validation Techniques

Training

SAS System and SAS Program Validation Techniques

Course Overview
This course will teach methodologies of performing SAS System validation including new installations and updating to a new version of SAS on a development server and promotion to a production server. 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.

About Instructor
Sy Truong is the cofounder and president of MXI (Meta-Xceed, Inc.) since 1997. MXI provides software solutions within the Pharmaceutical Industry specializing in CDISC data standards, SAS validation, electronic submission, data analysis and reporting. Sy is one of the committee members of the Bay Area SAS User Group (www.basas.com). He is a frequent contributor and presenter at PharmaSUG, WUSS, SAS Global Forum and CDISC Interchange conferences.

For pricing information and a quote for a customized training course, please contact MXI .

Course Introduction
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 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.

SAS Cluster SAS Grid Cluster SAS Grid SAS SAS Cluster System SAS Cluster Servers SAS Grid Computing SAS Plugin for MS Office SAS MS Office Plugin SAS Plugin for Excel SAS Plugin for MS Word SAS Excel SAS MS Word SAS Macro Interfeace for MS Office Generate Reports from CDISC Data SDTM Reports ADaM Reports Standard SAS Reports SAS Program Library SAS Macro Library CDISC Course CDISC Class SDTM Course SDTM Class CDISC Training CDISC Implementation Training CDISC Implementation Class MedDRA Training MedDRA Class WHO Drug Training WHO Drug Class AE Coding Training AE Coding Class Drug Coding Class Drug Coding Training DEFINE.PDF Training DEFINE .XML Training Domain Documentation Training Domain Documentation Class Data Definition Training Data Definition Class SAS Validation Training SAS Validation Class SAS System Validation Training SAS System Validation Class SAS Program Validation Training SAS Program Validation Class SAS Macro Training SAS Macro Class User Friendly SAS Macro Course User Friendly SAS Macro Training Programming Macro Training Programming Macro Class SAS Excel Course SAS Excel Training SAS MSOffice Course SAS MSOffice Training SAS MSWord Training SAS MSWord Course Change Control Training SAS Change Control Training SAS Program Change Control Training SAS Macro Change Control Training SAS Change Control Class SAS Program Change Control Class MedDRA Coding WHO Drug Coding MedDRA Coding Service WHO Drug Coding Service MedDRA Service WHO Drug Service Thesaurus Dictionary Management ADaM ADaM Consulting ADaM Service Analysis Datasets Analysis Datasets Consulting Analysis Datasets Service Annotated Case Report Form Annotated Case Report Form Consulting Annotated Case Report Form Service Annotated CRF Annotated CRF Consulting Annotated CRF Service Biostatistics Consulting Biostatistics Service CDISC ADAM CDISC ADAM Consulting CDISC ADAM Service CDISC Compliance CDISC Compliance Consulting CDISC Compliance Service CDISC SDTM CDISC SDTM Consulting CDISC SDTM Service Clinical Data Management Clinical Data Management Consulting Clinical Data Management Service CRF Design CRF Design Consulting CRF Design Service Data Management Service Design Case Report Form Design Case Report Form Consulting Design Case Report Form Service Discrepancy Management Discrepancy Management Consulting Discrepancy Management Service Edit Checks Edit Checks Consulting Edit Checks Service Electronic Submission Electronic Submission Consulting Electronic Submission Service SAS Consulting SAS Development Consulting SAS Development Service SAS Program Consulting SAS Program Service SAS Service SDTM Consulting SDTM Service Statistical Consulting Statistical Service Tables Listings and Graphs Tables Listings and Graphs Consulting Tables Listings and Graphs Service TLG Consulting TLG Service Coding Methodologies Contract Research Organizations CRO Data Library Managing Thesaurus Reconciling Dictionaries SAS Macros Table of Contents TOC Biostatistics Case Report Form Case Report Form Design Case Report Form Service CFR part 11 Clinical Data Management CRF Tabulations Custom Database Custom Database Consult Custom Database Design Custom Database Service Data Analysis Data Management Data Warehouse Design Clinical Plans Electronic case report Electronic submission FDA Submission IND Medical Device Medical Writing Ndas Prepare Patient Profile Consult Patient Profile Generator Patient Profile Service RFP SAS Consulting SAS Service SOP Consulting SOP Service Code Optimizer Data Models Data Standards Data Definition Define.xml Define.PDF Domain documentation Data Definition Documentation Coded Terminology Coded Terminology Management Coded Terminology Software SAS Format SAS Format Management CDISC Coded Terminology Coded Terms Coded Terms Coded Terms Software Controlled Terminology Control Terminology Controlled Terminology Management Control Terminology Management Control Terminology Software Controlled Terminology Software CDISC Controlled Terminology CDISC Control Terminology SAS Data Viewer Data Viewer Syview View SAS without lock SAS Dataset Viewer SAS Dataset View SAS Data View Generate Reports from CDISC Data SDTM Reports ADaM Reports Standard SAS Reports SAS Program Library SAS Macro Library