GMP Manufacturing Systems
CyberGXP helps organisations secure GMP manufacturing systems without disrupting validated operations or production continuity.
GMP manufacturing systems sit at the heart of regulated pharmaceutical operations, directly supporting product quality, patient safety, and regulatory compliance.
These environments rely on complex, interconnected IT and operational technology (OT) systems that must remain secure, validated, and available at all times.
Cyber incidents in GMP manufacturing are not just IT events — they are quality events. A security failure can disrupt production, compromise validated states, trigger regulatory findings, or result in costly batch loss or recalls.
What You’re Protecting
in GMP Manufacturing
GMP manufacturing environments include a broad range of regulated systems and technologies, often operating continuously and under strict change control.
Key assets include:
Manufacturing Execution Systems (MES)
Laboratory Information Management Systems (LIMS)
Quality Management Systems (QMS)
Industrial Control Systems (ICS) and SCADA
Operational Technology (OT) networks
Batch records, quality data, and release documentation
Each system plays a direct role in maintaining product quality and regulatory compliance.
Cyber Risks in GMP
Manufacturing Environments
GMP manufacturing systems face a unique blend of cyber and operational risk, particularly as legacy systems become more connected.
Common risks include:
Ransomware or malware disrupting production
Unauthorised changes affecting validated systems
Inadequate access control across IT and OT environments
Poor segregation between corporate IT and manufacturing networks
Limited logging and monitoring in OT systems
Third-party access risks from vendors and integrators
Any of these risks can place an organisation in a non-compliant state.
How CyberGXP Secures GMP Manufacturing Systems
Our approach is specifically designed for regulated manufacturing environments.
CyberGXP supports GMP manufacturing systems through:
GMP-aligned cyber risk assessments
IT/OT security architecture and network segmentation
Secure access management for operators, engineers, and vendors
Assurance of validated systems and interfaces
Logging, monitoring, and incident readiness for manufacturing environments
Support for regulatory inspections and quality audits
We work closely with QA and manufacturing teams to ensure security controls align with validated processes.
Regulatory & Compliance Expectations
Regulators expect GMP manufacturing systems to remain secure, controlled, and in a validated state throughout their lifecycle.
CyberGXP supports alignment with:
GMP requirements and quality system expectations
Annex 11 and 21 CFR Part 11
Data integrity principles (ALCOA+)
Change control and system validation requirements
Inspection readiness for manufacturing and quality systems
Cyber security controls must support validation — not undermine it.
Protecting Production
& Patient Safety
Disruption in GMP manufacturing can have far-reaching consequences — from delayed supply to patient harm and regulatory action. Cyber security must reduce risk without introducing instability or unplanned change.
CyberGXP helps organisations protect production continuity while maintaining compliance and inspection readiness.
Preparing for Ongoing Oversight
Following approval, GMP manufacturing systems remain under continuous regulatory oversight. Secure, well-governed manufacturing environments support post-approval operations, inspections, and long-term compliance.
Cyber security must evolve alongside manufacturing operations — without compromising validated states.
Secure Manufacturing.
Maintain Compliance.
If you operate GMP manufacturing systems and need to protect production, maintain validation, and meet regulatory expectations, speak to CyberGXP. We’ll help you secure manufacturing systems today, and stand up to inspection tomorrow.