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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • Guide

FDA Key Points for Regulated Life Science Industries

To meet increasingly rigorous requirements, UL Solutions recommends life sciences professionals master essential competencies prior to FDA inspections.

Scientist working in lab for drug production

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.

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