The following software is required prior to attending the class. Some of the software will be supplied by the instructor while others is required on the student's machine.
- Windows XP
- Internet Explorer or Mozilla Firefox
- Microsoft Office: Word and Excel
- Team Viewer - Desk sharing software for viewing course
- Sy/Validate -SAS program change management
and validation tool
Latest download will be made available before week of class.
Sy Truong is the cofounder and president of MXI (Meta-Xceed, Inc.) since 1997. XI 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, and SUGI conferences. He's currently writing a book for SAS Publishing entitled
Becoming a SAS Clinical Trials Programmer.
Change control functions as the fundamental process for quality control and is the foundation for validation. This is standard procedure for software development but is lacking in the development of analysis when programming in SAS. The unstructured adhoc nature of discovery during analyzing data and reporting create challenges from the perspective of change control and validation. However, it is this data driven dynamic programming environment that requires the rigors of change control to ensure the
integrity of the results. This course explores processes and
techniques used to manage change control of SAS programs and the output
they produce within the process of development and validation. Some of the examples it will cover include:
- Version Control - Backward compatibility issues with older versions of SAS programs and output
- Understanding Differences - Comparing differences between versions of programs and output
- Noted Changes - Capture metadata or information describing the meaning or the context of the changes
- Validation Process - Managing changes from requirements through the testing of all programs
- Reports and Documentation - Generate reports documenting all of
the changes from the perspective of validation
This course will demonstrate the challenges faced with managing change control of SAS programs in a regulated industry. One of the objectives is to simplify the process while maintaining the core elements of quality control through change control. In the recent history of computing, the use of the mouse and its right mouse click contextual menu has made it easier to access information upon object within its graphical user interface. This approach is used by Sy/Validate? software to simplify the process of managing change control of SAS programs and will be used to demonstrate how it can effectively document the validation process.