Governance and management
- Board-approved cybersecurity policy addressing pharma specifics
- CISO or designated cybersecurity responsible person appointed
- Management completed cybersecurity training (NIS2 requirement)
- Cybersecurity budget at minimum 5-8% of IT budget
- Cybersecurity integrated into business risk assessment
- Cybersecurity policy integrated with GMP quality system
- Regular management review (minimum quarterly) of cybersecurity posture
IT and OT infrastructure protection
- IT/OT network segmentation with dedicated firewalls
- EDR/XDR on all endpoints (including lab workstations)
- SIEM collecting logs from IT, OT, LIMS, EDC
- 24/7 SOC (internal or as a Service) with pharma expertise
- MFA on all accounts (including service technician VPN)
- Vulnerability management considering production maintenance windows
- SCADA/DCS monitoring without impacting production processes
- Secure configuration of LIMS, ELN, EDC systems
- VPN with MFA for all remote connections
- Elimination of unmanaged devices in OT networks
Data protection and compliance
- Data classification (clinical data, formulas, IP, personal data)
- DLP protecting clinical data and formulas from leaks
- Encryption at rest (AES-256) and in transit (TLS 1.3)
- 3-2-1 backup with offline (air-gapped) copy, monthly restoration tests
- GDPR compliance: DPIA for systems processing patient data
- NIS2 compliance: incident reporting procedures (24h/72h/30d)
- GMP Annex 11 compliance: audit trail, access control, validation
- 21 CFR Part 11 compliance (if exporting to US)
- Data processing agreements with IT suppliers
- Clinical data processing records up to date
Supply chain and incident response
- Cybersecurity risk assessment of critical suppliers (API, CMO, CRO)
- Cybersecurity clauses in supplier contracts (NIS2 requirement)
- Secure data exchange channels with partners (SFTP, S2S VPN)
- Serialization system integrity monitoring (FMD/EMVS)
- Business continuity plan (BCP) for cyberattack scenarios
- Incident response plan (IRP) accounting for GMP and NIS2
- Incident response exercises minimum twice a year
- IT and OT infrastructure penetration testing (minimum annually)
- Security awareness training for all employees (quarterly)
- Specialized training for IT, OT, and QA departments
- Post-incident procedure review and update
Cybersecurity for Your Industry
Learn more about cybersecurity in your industry:
Why this matters for organizations
Complete cybersecurity checklist for pharmaceutical companies in 2026. 50+ points covering IT, OT, GMP, and NIS2. In the context of growing cyber threats and tightening regulations (NIS2, DORA), organizations must proactively manage this security area. Failure to implement adequate safeguards can lead to data breaches, financial penalties, and reputational damage.
Best practices for implementation
Effective implementation requires several key steps:
- Risk assessment and inventory — identify assets, threats, and vulnerabilities specific to your organization.
- Policy development — document requirements, roles, and responsibilities.
- Technical controls — deploy tools and configurations proportionate to identified risks.
- Training and awareness — engage employees in protecting organizational security.
- Monitoring and continuous improvement — regularly verify effectiveness and adapt to the evolving threat landscape.
Related topics
See also:
