NIS2 for the chemical & pharma sector
Reactors, distillation units and pharmaceutical production lines fall under both NIS2 and sector-specific regulations (SEVESO III, GMP). OT security here directly affects safety and continuity.
OT systems that fall under NIS2
What NIS2 means for your OT
SIS integrity
Safety Instrumented Systems must never be tampered with. Yet in many older installations they are connected to the DCS network without strict isolation.
SEVESO reporting obligation
NIS2 requires incident reporting within 24 hours. Combine this with the SEVESO reporting obligation: every disruption notification must be carefully prepared.
GMP audit trail
In pharma, GMP Annex 11 requires a demonstrable audit trail for computer-controlled systems. NIS2 adds a security layer on top of this.
Three steps to NIS2 compliance
SIS isolation per IEC 62443
Strict separation of SIS and DCS network via hardware firewall. Monitoring of SIS traffic without interfering with the safety logic.
Combined notification procedure
Integration of NIS2 incident notification into existing SEVESO and/or GMP crisis response procedures. One timeline, one report.
DCS hardening and patch management
Structured patch management for DCS clients and historians, based on vendor advisories, with test protocol to manage production risk.
OT security and machine refit often go hand in hand. A refit to a modern PLC also improves your NIS2 posture.
Start your NIS2 assessment for Chemical & pharma
A gap analysis starts with a technical intake specific to your sector and OT landscape.