To gain efficiency, many manufacturers have turned to electronic documentation to comply with U.S. Food and Drug Administration regulations. Learn more about how SYSPRO helps companies simplify compliance with 21 CFR Part 11, a set of rules that dictate how FDA-regulated industries manage electronic records and electronic signatures.
“Because electronic documents are subject to greater risks of falsification, misrepresentation, and change than paper records, the FDA determined that electronic documents required special controls. This resulted in the introduction of 21 CFR Part 11.”
– Document Excerpt