FDA Key Points for Regulated Life Science Industries

ComplianceWire^® is UL Solutions’ best-in-class web-based platform specifically designed for highly regulated industries. Our experts designed it to effectively and efficiently automate the creation, delivery, and reporting of role-based training, qualification and compliance programs. ComplianceWire Learning Management System (LMS) was built to be compliant with 21 CFR Part 11 and EU Annex 11 validation requirements.

Since 1999, ComplianceWire, as well as UL Solutions’ Life Science e-Learning courses, have been the trusted learning solution used by the U.S. FDA to train more than 40,000 global, federal, state and local investigators.

Through our direct relationship, in tandem with feedback from our biopharma, medical device and healthcare customers, we have identified five distinct themes that we project FDA will be prioritizing in 2021 and beyond.

To meet these increasingly rigorous requirements, we recommend that life sciences professionals master these essential competencies prior to FDA inspections.