Carolyn Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device, and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn participated in the FDA/Industry team that drafted 21 CFR Part 11, the FDA Guidance for Electronic Records and Electronic Signatures (ER/ES). She is active in seeking ways to streamline the validation process and do what she terms “Common Sense Validation,” removing tasks that do not add value, but carefully taking a risk-based approach and using critical thinking to drive plans and activities.