Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistAll AssessmentsReadiness Assessment, 8 Questions, About 7 Minutes
Data Integrity & Part 11
Data integrity is a rising enforcement theme. Rate your electronic records and signatures against Part 11 and ALCOA+.
21 CFR 11.10(e)
Do your systems keep a reliable, reviewed audit trail?
Are audit trails on, tamper-evident, and actually reviewed?
What FDA inspects: 21 CFR 11.10(e), audit trail. See the trend