96061 Computer Systems Validation Principles and Practices6cp; 1hpw (lecture), 2hpw (workshop), on campus
There are course requisites for this subject. See access conditions.
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.
Spring session, City campus
Detailed subject description.