21 CFR Part 11 Data Management Are The Basis Of Data Integrity

The FDA's regulation 21 CFR Part 11 plays a critical role in ensuring pharmaceutical manufacturers properly manage and track their data. This regulation requires manufacturers to collect reliable, generally trustworthy electronic records and signatures. It also includes that "data shall not be easily falsifiable." When the requirements of this regulation are met, the resulting electronic records and signatures are considered to carry as much weight as their paper equivalents. Learn more about how Anritsu's achieves compliance with 21 CFR Part 11.