GxP Cybersecurity Assessments

Independent cybersecurity assessments for GxP-regulated environments — manufacturing systems, laboratory networks, OT infrastructure and medical devices — aligned to FDA cybersecurity guidance, NIS2 and NIST CSF.

Executive Overview

Cybersecurity has become a direct compliance obligation for pharmaceutical, biotechnology and medical device organisations. The FDA now specifically examines cybersecurity as part of manufacturing inspections, medical device cybersecurity requirements have been strengthened significantly through 2023 guidance, and the EU NIS2 Directive imposes mandatory security measures and incident reporting obligations on organisations in the pharmaceutical and medical device sectors.

For GxP-regulated organisations, cybersecurity risk carries a dimension that is absent in other sectors: a security compromise can directly affect data integrity, batch record reliability and product quality assurance. An uncontrolled modification to manufacturing system data, a ransomware event affecting laboratory information management systems or unauthorised access to audit trail records creates simultaneous cybersecurity and regulatory compliance risks that require coordinated response.

Sthira Assure GxP cybersecurity assessments examine security controls through both a cybersecurity and a regulatory compliance lens. We identify vulnerabilities in manufacturing networks, OT systems, laboratory environments and quality systems — and assess their impact on GxP compliance as well as information security. Our assessments are conducted by assessors who understand both the technical security requirements and the regulatory expectations of pharmaceutical inspectors.

Regulatory Frameworks

FDA Cybersecurity Guidance (2023)
EU NIS2 Directive
NIST Cybersecurity Framework
IEC 62443 (OT Security)
EU MDR / IVDR
EU GMP Annex 11
MHRA Cybersecurity Guidance

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Common Compliance Risks

Converging IT and OT Networks in Manufacturing

Pharmaceutical manufacturing increasingly relies on networked OT systems — DCS, SCADA, MES and process analytical technology — that were designed for availability and reliability rather than security. As these systems are connected to corporate IT networks and cloud services, they inherit cybersecurity vulnerabilities that legacy industrial control systems were not designed to withstand. Regulators and auditors are increasingly examining the segmentation between IT and OT environments.

Insufficient Cybersecurity Incident Management

GxP-regulated organisations are required to manage cybersecurity incidents in a manner that protects data integrity and product quality. Many lack incident response procedures specifically addressing GxP system compromise — including procedures for assessing whether data integrity has been affected, initiating regulatory notifications and conducting post-incident data recovery validation. A cybersecurity incident without adequate response capability can rapidly become a regulatory compliance event.

Inadequate Privileged Access Controls

Shared login credentials, generic system accounts and uncontrolled privileged access remain persistent findings in GxP cybersecurity assessments. These configurations directly conflict with data integrity requirements for individual accountability and audit trail integrity. Organisations that have not implemented role-based access controls, privileged access management and access review processes are exposed to both cyber risk and regulatory enforcement.

Medical Device Cybersecurity Compliance Gaps

The FDA's 2023 medical device cybersecurity guidance and EU MDR cybersecurity requirements have substantially raised the bar for device manufacturers. Pre-market submissions must include cybersecurity documentation, and post-market surveillance must address cybersecurity vulnerabilities. Device manufacturers who have not embedded cybersecurity into their design controls and post-market quality systems face increasing scrutiny at both product approval and inspection stages.

Scope of Services

GxP cybersecurity risk assessments for manufacturing and laboratory systems

OT and IT network security assessments for regulated environments

FDA cybersecurity readiness reviews for medical devices and manufacturing

NIS2 Directive gap assessments for critical infrastructure organisations

Network segmentation and segregation reviews

Vulnerability management programme assessments

Security control effectiveness reviews for GxP systems

Privileged access management reviews

Backup and recovery procedure assessments for GxP data

Incident response plan review for regulated environments

Typical Deliverables

→GxP Cybersecurity Risk Assessment Report

→OT/IT Network Segmentation Review Report

→Vulnerability Assessment Summary

→Access Control Review Report

→FDA Cybersecurity Readiness Gap Assessment

→NIS2 Compliance Gap Analysis

→Incident Response Plan Review

→Cybersecurity Remediation Roadmap

Frequently Asked Questions

Are there specific regulatory requirements for cybersecurity in pharma?

Yes. FDA has issued specific cybersecurity guidance for medical devices (2023) and has incorporated cybersecurity expectations into manufacturing inspection programmes. EU NIS2 Directive (2024) applies to pharmaceutical manufacturers meeting the essential entity thresholds, introducing mandatory incident reporting and security measures. EU GMP guidance on computerised systems (Annex 11) requires appropriate security measures for GxP systems, and MHRA has issued specific cybersecurity guidance for medical devices.

What is the difference between a cybersecurity assessment and a traditional IT audit?

A GxP cybersecurity assessment specifically examines security controls from the perspective of their impact on regulatory compliance and product quality — including data integrity, audit trail integrity, access control and system availability. Traditional IT security audits focus on confidentiality, integrity and availability from an information security perspective without the specific regulatory lens required for GxP environments. Both perspectives are relevant; our assessments address both.

Does cybersecurity apply to OT systems like process control and SCADA?

Yes. OT systems used in pharmaceutical manufacturing — DCS, SCADA, MES, process analytical technology and building management systems — are GxP systems subject to the same data integrity and security requirements as laboratory information management systems and quality management systems. OT cybersecurity assessments address network segmentation, patch management in operational environments, remote access controls and industrial control system-specific vulnerabilities.

What does NIS2 require for pharmaceutical manufacturers?

NIS2 applies to pharmaceutical manufacturers classified as essential or important entities under EU Directive 2022/2555. Requirements include implementation of risk management measures covering network and system security, incident handling, supply chain security, access control and cryptography, mandatory reporting of significant incidents to national authorities within 24 hours of detection, and senior management accountability for NIS2 compliance. Non-compliance can result in significant financial penalties.

Discuss Your Cybersecurity Compliance

Contact our team to discuss your GxP cybersecurity obligations, network environment and the assessments your organisation requires.

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