Requirements for Computerized Systems Validation and Compliance

This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.

After this course learners will be able to recognize the regulatory requirements for the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices.