Stelex University, the professional education and technical training arm of Stelex- The Validation Group, Inc., has presented a training session entitled "Computer Systems Validation in a Good Laboratory Practice (GLP) Environment" for the FDA's NCTR group located in Jefferson, Arkansas.
The topics of the session included:
- Overview of the need for Computer Systems Validation (CSV) in a FDA- regulated environment
- Maintaining a computer system in a validated state
- The context in which CSV will be reviewed by the FDA
- The auditing of computer systems
- The concepts, terminology and methodology used in a System Life Cycle (SLC)
Stelex U has contributed to Stelex's success by keeping a constant focus on the ever-changing technological and regulatory environments and transferring this knowledge to their consultants and clients.
Instructor James Bardunias stated, "The FDA does not normally go around asking people to come and train their staff; so when they do, not only is it a rare opportunity, it is an honor."
Information Technology at NCTR encompasses the use of computers for automated data collection systems, computational science analysis, and a network infrastructure that includes servers, a high-speed LAN, and multiple T1 lines to the FDA in Maryland.
With long-lasting results in mind, the Computer Systems Validation and Quality Auditor training will help assure that studies performed by NCTR are regulatory-compliant and meet expectations related to the control of computer systems used in their studies.
In reference to the training conducted by Stelex U, NCTR Acting Director Dr. William Slikker Jr. stated, "I have already received positive feedback."