Secure Production Without Risking Validation
Agentless OT security that protects GxP-validated systems, batch processes, and legacy lab equipment without triggering revalidation
Protect pharmaceutical manufacturing from cyber threats without installing software on validated systems. TXOne delivers network-based and portable security that maintains GxP compliance, batch integrity, and audit trail requirements from production floor to quality lab.
Pharmaceutical Manufacturing and Life Sciences
In validated environments where software changes cost $50K-$500K in revalidation, security must work without touching qualified systems
Pharmaceutical manufacturers face a unique constraint: validated production systems cannot accept software changes without expensive revalidation cycles. Meanwhile, 25% of top OT security incidents are triggered by removable media, and legacy lab instruments run operating systems with no vendor support. TXOne provides agentless and network-based protection that secures your validated environment without touching your qualified systems.
THE CHALLENGE
pharmaceuticals Security Challenges
Critical security challenges facing pharmaceuticals organizations today.
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Validated Systems Block Security Updates
Production systems qualified under FDA 21 CFR Part 11 and EU Annex 11 cannot accept software installations or patches without triggering full revalidation. Traditional endpoint security is incompatible with validated environments, leaving critical systems exposed.
Validated Systems Block Security Updates
Production systems qualified under FDA 21 CFR Part 11 and EU Annex 11 cannot accept software installations or patches without triggering full revalidation. Traditional endpoint security is incompatible with validated environments, leaving critical systems exposed.
TXOne Pharmaceutical Protection
Agentless security inspection, network-based threat prevention, and legacy endpoint coverage designed for GxP-validated pharmaceutical environments.
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Validation-Preserving Media Security
TXOne Element and Portable Inspector scan USB devices and removable media before they enter validated zones, without installing software on qualified systems. Safe Port kiosks process 7,200 files per minute at facility entry points with LED pass/fail indicators for non-technical operators.
Validation-Preserving Media Security
TXOne Element and Portable Inspector scan USB devices and removable media before they enter validated zones, without installing software on qualified systems. Safe Port kiosks process 7,200 files per minute at facility entry points with LED pass/fail indicators for non-technical operators.
Measurable Business Outcomes
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Revalidation Cost
Revalidation Cost
WHY TXONE
Why TXOne for Pharmaceuticals
Purpose-built for GxP-validated environments where equipment revalidation costs millions, batch integrity is non-negotiable, and legacy lab equipment must stay qualified.
Agentless Portable Inspector and network-based Edge appliances protect GxP-validated systems, chromatography equipment, and batch controllers without installing software or triggering revalidation cycles.
Legacy approach creates operational risk
Automated audit trails map to 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 requirements. Security generates the documentation quality and regulatory teams need without manual reporting.
Legacy approach creates operational risk
Full offline operation with USB-delivered updates keeps air-gapped labs and cleanroom systems protected without connecting to the enterprise network. Safe Port validates contractor media at facility entry.
Legacy approach creates operational risk
LEARN MORE
Pharmaceutical Security Resources
Whitepapers and compliance briefs for GxP, 21 CFR Part 11, and EU GMP Annex 11 environments.
Building Cybersecurity Immunity in Pharma: A Strategy for CISOs
As digital transformation accelerates, the cyberattack surface has expanded significantly. Cybercriminals are increasingly targeting pharmaceutical companies, driven by the high value of their intellectual property and sensitive data. The sector’s ecosystem presents numerous vulnerabilities due to a blend of legacy systems and new technologies, making data theft and system manipulation prime threats. With the shift… Read more
Annual OT/ICS Cybersecurity Report 2024
As the line between IT and OT continues to blur, new efficiencies are unlocked in tandem with new risks—namely, supply chain vulnerabilities, aging infrastructure, patching difficulties, and gaps in incident response. These challenges are the main focus of our Annual OT/ICS Cybersecurity Report, which is grounded in a large-scale survey conducted jointly by TXOne Networks… Read more
OT Patch Management Playbook: Defend Without Disruption
Operational Technology (OT) environments are the backbone of critical infrastructure, encompassing industries such as manufacturing, utilities, energy, as well as food and beverage. OT encompasses hardware and software designed to monitor and control physical equipment, processes, and events within organizations. These systems are typically built for longevity, often operating for over a decade. However, these… Read more
See All Resources
Browse all resources related to pharmaceuticals
NEXT STEP
Ready to Secure GxP Production Without Risking Validation?
A TXOne engineer reviews your batch-process controls, cleanroom systems, and quality labs; identifies validated equipment and air-gapped environments most exposed to ransomware; and shows how agentless and network-based protection deploy on GxP systems without triggering revalidation or breaking batch integrity.