Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug. To satisfy regulatory expectations, these computer systems should be validated. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data […]Read More
Author: Debra Fontana
Debra Fontana is a Quality Assurance Manager at Certara. She is responsible for the overall Quality Management System at Certara. She has been performing computer system validations for large pharmaceutical companies and CROs for over 15 years. When not working, she enjoys kayaking, reading, and gardening. Ms. Fontana is the proud mother of a son who is a college sophomore at UNC-Chapel Hill.