Pharma OT & GxP Cybersecurity Handbook 2026 by Kai London
In a regulated plant, "we cannot patch that, it is validated" has become a security posture. It is not one. This handbook shows how validation and cyber security can be run as one discipline — protecting product quality, patient safety and the data the regulator will inspect.
Available on Amazon. An independent practitioner guide — not affiliated with or endorsed by any regulator or inspectorate.
What is inside
Validation and security together
Running computerised system validation and security control design as one lifecycle instead of two competing ones.
Data integrity
Audit trails, electronic records and signatures, and the access control that makes attributable data actually attributable.
Change control that allows patching
Risk-based assessment, revalidation scope and maintenance windows — closing vulnerabilities without breaking qualification.
Segmentation on the production floor
Process control, building management, laboratory and serialisation systems separated with controls a site can maintain.
Supplier and equipment assurance
Security requirements for OEM skids, lab instruments and integrators, set before the equipment arrives.
Inspection readiness
Documentation, deviation handling and incident evidence presented in the language quality and inspectors already use.
Who it is for: pharmaceutical and biotech OT and IT security leads, validation, quality and compliance teams, site engineering and automation managers, and CISOs covering manufacturing networks.
A validated system that cannot be patched is not compliant. It is merely documented.
About the author
Professor Kai London — CISSP, CISM.
An internationally recognised cybersecurity executive, board advisor and Founder & CEO of Quantum AI Systems Security LLC, writing at the convergence of AI, governance and operational resilience. Honorary Professor and Researcher at UCL.