Pharmaceutical
Secure your systems and stay HPRA audit ready with GMP-aligned IT governance.
Control access, protect batch records, and keep audit trails ready for HPRA before an inspector asks
HPRA IT Compliance and Data Integrity Risks
PHARMACEUTICAL
Access is not kept tight as teams change
Old permissions stay active longer than they should, and that's a gap an inspector finds fast.
Audit trails are not always defensible
Batch records and approval trails need to hold up on the spot, since a gap an inspector finds midaudit costs more than the fix ever would.
Systems are not consistently validated
Change control drifts as systems update, and an undocumented change is exactly what an HPRA inspection flags first.
EU GMP Annex 11 Requirements for Pharmaceutical IT
The expectation has shifted from having controls to proving them.
That means you can show:
• ISO 27001 aligned cybersecurity governance
• 24/7 monitoring and tested backups
• governed access with a clear audit trail •
defensible batch records and approval logs
• validated, documented system change control
Pharmaceutical IT Governance Risks in Ireland
Risk builds where regulated data sits across systems with access that hasn’t kept pace with staff and team changes.
Add an HPRA inspection and a gap in the audit trail, and a small oversight becomes a compliance finding, unless it’s managed deliberately.
IT Governance for Pharmaceutical Companies in Ireland
Hybrid builds Technology Success into every regulated environment we serve. Centralised Services keeps batch records, approval trails, and access logs governed and available, helping your team maintain an audit-ready trail during an active inspection. Your vCIO turns that foundation into a roadmap aligned with your compliance timeline and business goals. Engineers who understand regulated environments monitor your systems every day and answer fast when something needs attention.
Want a clear view of your biggest exposure points?
Cyber Security Services
Threat Detection and Prevention
- Proactive Threat Protection: We deploy layered threat protection across your entire environment using licensed firewalls (SonicWall, Cisco, Meraki, Unifi, Ubiquiti, TP Link), antivirus (BitDefender, ESET, Microsoft Defender), and email scanning (Vade, Defender) to detect and neutralise threats in real time.
- Multi-Factor Authentication: We secure every login with MFA, adding an extra layer of verification that stops unauthorised access before it becomes a breach.
Watch Our Webinar to learn more about a live ransomware attack and about the top solutions out there to protect your data.
Security Audits and Compliance
- Regular Audits: Ensuring your business meets all necessary regulatory requirements, keeping you compliant and secure.
- ISO 27001: Conduct a GAP analysis to identify security gaps, prioritizing issues using a traffic light system for efficient resolution, ensuring ongoing adherence to ISO 27001 standard and other regulations.
Gain insights from our ISO 27001 Case Study and its impact on business.
Business Continuity and Disaster Recovery (BCDR)
We build recovery strategies designed to restore your business operations fast after any disruption, keeping your data protected and your team back online as quickly as possible.
- Minimise Downtime: Our Recovery Point Objective (RPO) ensures backups run three times a day, minimising data loss and keeping your business as close to normal as possible.
- Fast System recovery: Our Recovery Time Objective (RTO) focuses on getting your systems back online quickly, powered by Datto RMM to reduce the time your business is offline.
- Backup Integration: We ensure data integrity and continuous protection through proactive backups, fully integrated with Datto RMM.
What’s your Plan B? Every Irish business needs one.
Get in Touch with our team today and we will build a BCDR plan around your business.
Software Security Patching
- Proactive Patch Management: Testing and deploying security updates after thorough evaluation.
- Comprehensive Service: Managing the patching process, including server-related and Microsoft Windows server updates.
Stay Up to Date and ensure your software is secure with our patching service.
Remote Monitoring and Management (RMM)
- Endpoint Monitoring: Continuous monitoring of every device, catching issues before they reach your business.
- Integrated SOC and EDR Services: SOC and EDR combined to detect and respond to threats across every endpoint.
- Automated Maintenance: Software updates and security patching automated, keeping your systems secure and current.
Incident Response and Recovery
Immediate Action: Preparedness to respond swiftly to any security incidents to protect business continuity.
Respond to Threats and Contact Us for rapid incident response.
Employee Training and Awareness
- Security Awareness Training: We equip your team with the knowledge to recognise phishing attempts, social engineering, and cyber threats before they cause damage.
- Phishing Simulation Tests: We run realistic phishing simulations to test and strengthen your team’s ability to spot and respond to real-world attacks.
Why Choose Us for Cybersecurity and Monitoring
“The question is never if your business will be targeted. The question is whether you will be ready.” – Paul Browne, MD
When you choose us for cybersecurity and monitoring, you get more than protection. You get a dedicated team of security engineers who know your environment, respond fast, and treat your security as their own responsibility.
Frequently Asked Questions
What does the EU GMP Annex 11 revision mean for pharmaceutical IT?
Annex 11 places cybersecurity, access controls and data integrity at the centre of GMP compliance, so audit trails and access logs need to hold up on demand, actively maintained rather than left to sit.
Where do pharmaceutical cybersecurity risks typically come from?
Risks build through access that hasn’t kept pace with staff changes, audit trails with gaps, and validation records that fall behind system updates.
Do pharmaceutical companies need ISO 27001 certification?
It isn’t a legal requirement, but it’s increasingly expected by customers and auditors as evidence of managed cybersecurity risk ahead of Annex 11 taking effect.