Pharma Company Meets Standards for 21 CFR 11 with Ignition

When Bachem Americas needed a system for human-machine interface (HMI) and supervisory control and data acquisition (SCADA), it required one that could not only improve its processes, but also satisfy requirements from the United States Food & Drug Administration (FDA). The FDA’s Title 21 of the Code of Federal Regulations Part 11 — also known as 21 CFR 11 — establishes rules for the use of electronic records and signatures, covering authentication, confidentiality, integrity, availability, and more.