Case Study: Bachem Americas achieves FDA 21 CFR Part 11 compliance with Ignition by Inductive Automation

Bachem Americas - Customer Case Study

Bachem Americas, a pharmaceutical and biotech company with facilities in California, needed an HMI/SCADA system for a peptide manufacturing step that would also meet FDA 21 CFR Part 11 requirements. The company chose Ignition from Inductive Automation to improve operations while ensuring compliance for electronic records, signatures, authentication, and auditability.

Inductive Automation, working with system integrator Wunderlich-Malec Engineering, implemented a custom Ignition application with data historian, trending, alarming, audit trails, reporting, and Active Directory authentication. The solution simplified validation, testing, troubleshooting, and expansion, reduced costs through unlimited licensing, and gave Bachem a platform it plans to roll out across the Vista site and eventually Torrance as well.

Bachem Americas

Tim Tran

Site Manager