Regulatory inspections shouldn’t require weeks of searching for records, rebuilding audit trails, and pulling teams away from their day-to-day work. This blog explores why organisations are moving from reactive inspection preparation to continuous compliance, and...
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.
Compliance Builder 12 introduces several enhancements that directly support stronger compliance control and faster issue detection, helping organizations prevent minor issues from becoming major CAPA violations.
Real-time monitoring involves assessing data compliance as it changes, rather than after issues arise during review.
