Understanding the requirements for 21 CFR Part 11 compliance can be challenging for pharmaceutical and biotech companies. In this first episode of Ask the Expert, we interview Curtis Egan, a 21 CFR Part 11 expert and discuss the history of the FDA regulation, key aspects for compliance, and the role software plays in meeting 21 CFR Part 11 compliance.
Tune in and learn about the:
background and overview of 21 CFR Part 11 and where it applies
importance of data security practices for open vs closed systems
features of the FACSuite software that enable 21 CFR Part 11 compliance