Carolyn Troiano

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

About

Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.

Credentials

  • 45+ Years CSV Experience
  • 21 CFR Part 11 Co-Developer
  • Independent FDA Consultant

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