Pharmaceutical
Your HPRA audit deserves an IT environment built for it.
EU GMP Annex 11 makes cybersecurity a core GMP requirement in 2026, explicitly referencing ISO 27001 as the relevant standard. Ireland has close to 300 pharmaceutical companies under HPRA & FDA oversight, and the compliance bar just got higher.
What Irish pharmaceutical companies face in 2026
Defensible records depend on governed IT
Batch records, approval trails, and audit logs need consistently available, controlled IT to stay complete, accurate, and ready to stand up to scrutiny.
Data integrity depends on controlled access and change
As teams, roles, and systems change, access management and structured IT change control are critical to keeping data integrity requirements intact.
High value pharmaceutical data needs stronger protection
Patient records, research IP, and proprietary formulations are highly targeted, which means layered security is essential to protect sensitive data and reduce risk.
Structured IT governance for regulated pharmaceutical environments
Your vCIO provides strategic IT leadership aligned to your HPRA inspection schedule and Annex 11 obligations. Every technology decision supports your compliance timeline.
- Your Technical Account Manager conducts ongoing reviews and ISO 27001 GAP analysis, giving leadership clear, continuous visibility of security posture and compliance standing between inspections.
- Security Plus Complete delivers ITDR, EDR, SAT, and SIEM across your environment. Phishing simulation tests keep your team prepared.
- Datto RMM-powered BCDR ensures backups run three times daily, with a tested recovery time objective protecting your operations and your records.
Getting your IT environment HPRA-ready
Environment assessment. Every system mapped against your GMP, HPRA, and Annex 11 obligations.
vCIO-led roadmap. IT strategy aligned to your compliance timeline and your business goals.
Ongoing management. 24/7 monitoring, proactive patching, ISO 27001 audits, and BCDR. Continuous.
Speak to an engineer who understands pharmaceutical environments
The 2025 draft revision expands Annex 11 to nineteen pages and makes cybersecurity a core GMP requirement. It requires access controls, multi-factor authentication, patch management, incident response, and penetration testing for high-risk systems, explicitly referencing ISO 27001. Irish pharmaceutical companies using computerised systems for GMP activities need IT governance aligned to these requirements before the final version takes effect.
GMP data integrity follows the ALCOA principle: records must be Attributable, Legible, Contemporaneous, Original, and Accurate. This requires role-based access controls, audit trails capturing every change with a timestamp and user ID, consistent system behaviour, and tested recovery processes that preserve record completeness. A cyberattack or outage compromising any of these constitutes a GMP violation.
Under the revised Annex 11, GMP cybersecurity requirements include access controls with multi-factor authentication, patch management, malware protection, network security, incident response planning, and penetration testing for high-risk systems. As ISO 27001 lead auditors, we align pharmaceutical IT governance to both Annex 11 and ISO 27001 as an integrated programme through our Security Plus Complete service.