The United States Food and Drug Administration requires certain manufacturing industries to maintain strict records.
Title 21 Code of Federal Regulations Part 11 (21CFR11) is a comprehensive legislation that provides criteria for
using electronic records and signatures in the place of their handwritten equivalents. It addresses confidentiality,
authentication, integrity, availability, and non-repudiation. 21CFR11 further specifies details about general
security guidelines, auditing, training, validation, and additional procedural and administrative controls.
When properly implemented, Ignition can help manufacturers in regulated industries achieve and maintain compliance.
The bigger goal is to improve efficiency, simplify manufacturing, help with patent filing, and standardize your
process. 21CFR11 is necessarily relevant to manufactures who submit their records to the FDA for review. Many
guidelines represent “common sense” and “good practice” for manufacturers.
To learn how Ignition can create 21CFR11 compliant systems, download the white paper,
“Creating a 21CFR 11 Compliant Application with Inductive Automation”.