Our recent webinar, “When SEND Quality Matters Most”, explored the recent FDA communications regarding data quality, why regulatory expectations are shifting, where common issues arise, and how organizations can strengthen confidence before filing SEND datasets...
Comprehensive electronic recordkeeping is a cornerstone of all laboratory functions in regulated industries, but establishing and maintaining 21 CFR Part 11 compliance is challenging when processes are fragmented across multiple instruments and systems.
FDA Form 483 observations related to data integrity remain a persistent issue for the industry, and the consequences for a lab are significant.
Turning Insight into Innovation in Preclinical R&D
“For the first time, the FDA openly acknowledged that they are rejecting some SEND datasets because the quality isn’t good enough. No ambiguity. Just a clear statement that quality matters, and that poor SEND has...
SEND 4.0 introduces one of the most significant updates to nonclinical data standards, expanding scientific coverage and modernizing core structures across the SEND ecosystem. This white paper outlines the key changes such as new domains,...
