University of Technology, Sydney

Staff directory | Webmail | Maps | Newsroom | What's on

96061 Computer Systems Validation Principles and Practices

6cp; 1hpw (lecture), 2hpw (workshop), on campus; availability: science students wishing to enrol in this subject as an elective must send a one-paragraph expression of interest for consideration to science.admin@uts.edu.au
There are course requisites for this subject. See access conditions.

Description

Information technology is a rapidly evolving field, and the development processes for information technologies are shifting equally fast. In this subject students review Computer System Validation (CSV) methodologies for changing environments, and navigate through guidance and current industry best-practices related to Good Automated Manufacturing Practices (GAMP). Students examine all stages of the software development lifecycle, including electronic records, electronic signatures, current regulatory requirements, and computer systems validation documentation and testing. Finally, students assess the criticality of computer systems validation to pharmaceutical manufacturing.

Typical availability

Spring session, City campus


Detailed subject description.

Access conditions

Note: The requisite information presented in this subject description covers only academic requisites. Full details of all enforced rules, covering both academic and admission requisites, are available at access conditions and My Student Admin.