Approach to Computerized Systems Validation and Compliance

This course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices that are required to meet FDA’s regulations. It identifies ways to organize policies and procedures, and plans FDA expects a manufacturing company to establish. This course draws on current industry good practice. Though it also draws on FDA medical device guidance, this course is not intended to describe an approach to developing software that subsequently becomes part of a medical device. This is the second course in a series of four courses. Before taking this course, you should have successfully completed Requirements for Computerized Systems Validation and Compliance.

After this course learners will be able to identify the type of framework that is suitable for computerized systems validation and compliance. recognize planning and reporting requirements. recognize how a validation strategy is selected and the activities that are required to ensure ongoing compliance.