Description
This online program offers an introduction to the international principles and regulations behind computer systems validation. Course objectives include the following: to offer an understanding the computer systems life-cycle and the fundamentals of computer systems validation. In the medicines and healthcare products industries, computerized systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This course describes the planning of such validation. It outlines FDA requirements on electronic records and electronic signatures and describes in detail how to assess software suppliers and their products. It sets out principles of GAMP®5, risk assessment, and risk management. It follows the work of a pharmaceutical company’s team as they validate the dispensary control system for a new production line.
Once all course requirements have been satisfied, a certificate of completion is immediately available in PDF format. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade. Following a brief introduction, topics covered in this course include: Validation plan and strategy, planning phase, and a conclusion that summarizes the previously listed topics.
