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Thinking on Regulated Digital Transformation

Technical perspectives on compliance, OT/IT security, and building digital capability in environments where accuracy and adherence to regulations are mandatory.

OT/IT Security
NIS2IEC 62443OT Security
Featured March 2026 8 min read

What NIS2 Means for OT Environments in Dutch Manufacturing

The NIS2 directive is reshaping cybersecurity obligations for Dutch manufacturers. For organisations operating OT environments — bioreactors, clean rooms, industrial control systems — the implications go far beyond IT governance.

NIS2IEC 62443OT SecurityManufacturing
JD
Jasper Donkers
Management Consultant
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Compliance 12 min read

Mapping IEC 62443 to NIS2: A Practical Framework for Asset Owners

NIS2 defines the 'what' — IEC 62443 delivers the 'how.' This article provides a practical mapping between the two frameworks, helping asset owners translate regulatory obligations into concrete security controls.

NIS2IEC 62443ComplianceRisk Assessment
Jasper Donkers · February 2026
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GxP 6 min read

Five Things to Get Right Before Your EU GMP Annex 1 Compliance Audit

The revised EU GMP Annex 1 on sterile manufacturing raises the bar for environmental monitoring, data integrity, and computerised system validation. Here are the five areas auditors look at first.

EU GMP Annex 1GxPPharmaAudit Readiness
DCC Team · January 2026
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OT/IT Security 10 min read

OT/IT Network Segmentation Patterns for Bioreactor Environments

When connecting a Cytiva Xcellerex XDR bioreactor to your corporate network, how do you balance operational accessibility with security isolation? A three-VLAN architecture with IEC 62443 and Cisco ISE integration.

IEC 62443Purdue ModelCisco ISEBiotech
Jasper Donkers · January 2026
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Digital Transformation 7 min read

Assessing Digital Maturity in Regulated CDMOs: Where to Start

Cell and gene therapy CDMOs face a unique digital maturity challenge: they must move fast to scale manufacturing while maintaining GxP compliance at every step. Here’s how we approach the assessment.

CDMOGxPDigital MaturityCell & Gene Therapy
Kees Mensch · December 2025
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Digital Transformation 9 min read

Selecting a GxP-Compliant Technology Stack for Regulated Manufacturing

When every software decision carries regulatory implications, how do you select a technology stack that serves both innovation and compliance? Our approach to vendor evaluation in GxP environments.

GxPSaaSVendor Selection21 CFR Part 11
DCC Team · November 2025
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