In pharmaceutical manufacturing and clinical environments, connected devices operate under a unique convergence of pressures: validation requirements that make patching complex, patient safety that makes availability non-negotiable, and strict cybersecurity requirements under 21 CFR Part 11, EU GMP Annex 11, NIS2 and the EU Cyber Resilience Act.
Patching triggers revalidation
A vulnerability in a validated system is not patched on a Tuesday — it may stay open for a year while the revalidation cycle runs.
Everything is increasingly connected
MES feeds ERP, instruments connect to LIMS, clinical devices talk to hospital systems. Each connection is a potential attack vector.
Data integrity is a regulatory requirement
Unauthorised access or manipulation of production and laboratory records has direct regulatory consequences.
Device-level protection — without disrupting operations
Protect validated systems without revalidation
Locks install externally. The validated system is not touched — no software, no configuration change, no firmware update. It stays exactly as validated.
Control and audit third-party access
Vendors, service engineers and inspectors get time-limited, device-specific access with full audit trail — supporting Part 11 and Annex 11 requirements.
Reduce attack surface for unpatched systems
A hidden system has no exposed surface for known CVEs to exploit — risk reduced by more than 90% without touching the vulnerability.
Segment manufacturing and clinical systems
MES, quality platforms and instruments each get their own policy — preventing lateral movement even on shared infrastructure.
Pharmaceutical manufacturing (GMP)
Protect MES, SCADA and process control. Auditable remote access for engineers and vendors, inspection-ready logs.
Laboratory instruments & LIMS
Control which users and systems reach which instruments — protecting data integrity where it is a regulatory requirement.
Clinical devices & hospital IoT
Devices that cannot be patched without re-evaluation are protected externally — invisible to reconnaissance, open to authorised care and maintenance.
PKI identity and session logs support 21 CFR Part 11 and EU GMP Annex 11 audit trail requirements. NIS2 supply chain and access management articles are directly addressed, and XoT is developed under an SDL with SBOM transparency for CRA alignment.
See your assets disappear
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