Known as a dominant 21 CFR Part 11 compliant and validated LMS, this time-tested technology is used extensively by U.S. and global pharmaceutical, medical device and biologics companies. ComplianceWire has been the trusted technology used by the FDA to train more than 36,000 global, federal, state and local investigators.

The agency chose ComplianceWire as their training solution to ensure the proficiency of their investigators under a unique Cooperative Research and Development Agreement (CRADA). This solution integrates the ComplianceWire web-based platform with curriculum we co-develop with the FDA. The same technology platform and coursework used by the FDA and its virtual university are available exclusively to UL’s customers.

“Life Science companies appear to not be taking full advantage of better communication and guidance from the FDA. One-half of Life Science firms overall, and nearly two-thirds of Medical Device companies surveyed (62 percent), admitted that they are not incorporating the Agency’s feedback into their product development progress. In addition, a significant number said they do not participate in stage review meetings, especially later in the product approval process.”

–Pharma 2020: The Vision – which path will you take?, PriceWaterhouseCoopers