With the release of eQCM 10.01, Instem is introducing tighter document control and audit trail integrity for regulated environments.
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.
Version 5.3 introduces new modules for automated and validated sleep analysis alongside improved signal processing and reporting, supporting robust and compliant physiological research.
From preparation to analysis and reporting, BioRails actively supports the entire experimental workflow.
FDA Form 483 observations related to data integrity remain a persistent issue for the industry, and the consequences for a lab are significant.
