Carolyn Troiano has more than 40 years of experience in Computer System Validation (CSV) and compliance in the pharmaceutical, medical device, tobacco, and other FDA-regulated industries. She is currently an independent consultant advising companies on computer system validation and large-scale IT system implementation projects. She also delivers webinars and seminars on topics related to CSV, 21 CFR Part 11 (Electronic Records/Signatures), and data integrity compliance.
Carolyn has worked in industry supporting CSV for most of her career and has adapted the ISPE GAMP5 “V” Model for use with an agile methodology for system development, testing, implementation, and support. Her approach is in line with the Computer Software Assurance (CSA) methodology that focuses on critical thinking rather than documentation, requiring us to shed our compliance blinders. Instead of asking what deliverables are needed, we should start by asking why we’re doing things in the first place and tempering our testing and validation accordingly, along with following a risk-based approach.
Posted in Who’s Who at EAS.