Regulatory & Compliance
IT Audits & ISO 27001.
Information Security Compliance in the Life Sciences. We assist pharmaceutical, biotech, and medtech companies with targeted IT security audits and the seamless implementation of Information Security Management Systems (ISMS) in accordance with ISO 27001.
Why is IT security particularly critical in the life sciences?
Life sciences companies are highly attractive targets and are also subject to extremely strict regulatory oversight.
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Privacy & IP.
Clinical data, regulatory documents, and intellectual property (IP) are prime targets for ransomware and targeted industrial espionage.
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OT Security.
GMP-critical production systems and networks (OT/SCADA) have evolved over time and are often inadequately secured against modern cyberattacks.
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Regulatory pressure.
MDR and international regulations (FDA) are increasingly requiring explicit cybersecurity measures and evidence of compliance for networked medical devices.
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Supply chain risks.
Major clients and strategic partners now require ISO 27001 certification as a mandatory contractual prerequisite for cooperation.
When was your last formal IT security audit—and have you already addressed all critical findings?
ISO 27001 ISMS and Cybersecurity Audits.
We conduct a structured assessment of your IT security risks, identify blind spots, and implement robust ISMS systems in accordance with ISO 27001.
IT Security Audit & Gap Analysis
A structured IT audit against ISO 27001 requirements and life sciences-specific IT risks. We assess your network architecture, access management, incident response, and data backup strategies, and provide a findings report.
ISMS Implementation (ISO 27001)
Implementation of a comprehensive information security management system. We establish risk assessment, security policies, asset management, access control, and business continuity, and provide targeted preparation for certification.
Cybersecurity for Medical Devices
Strategic consulting on regulatory cybersecurity requirements (MDCG 2019-16, FDA Guidance, IEC 81001-5-1). Assistance with integrating robust cybersecurity measures into your design controls and risk management.
IT Vendor Audits & Cloud Assessments
Auditing of IT service providers and cloud providers against ISO 27001 and specific life sciences requirements. We assess the information security of SaaS solutions for eQMS, LIMS, and other regulated applications.
What does an ISO 27001 IT audit assess?
An ISO 27001-compliant IT audit evaluates the entire information security management system: risk assessment processes, implemented technical controls (Annex A), management oversight, incident response, business continuity, and supplier security.
Is ISO 27001 mandatory in the pharmaceutical and medical technology industries?
ISO 27001 is not directly required by law. However, regulatory requirements for information security measures are mandated by GMP Annex 11, FDA 21 CFR Part 11, and—for medical devices—by the FDA Cybersecurity Guidance and MDCG 2019-16.
How does an IT audit differ from a GMP audit?
A GMP audit evaluates quality systems, documentation, and processes with regard to patient safety. An IT audit focuses exclusively on information security (networks, access rights, data security, cyber resilience). Computer System Validation (CSV) serves as the bridge between the two.
What are the critical IT security risks in the pharmaceutical industry?
The main risks include ransomware attacks on OT/SCADA systems (production downtime), loss of clinical data (regulatory risk), phishing attacks on QA/RA teams, and inadequately secured third-party cloud applications (SaaS).
Frequently Asked Questions About IT Audits and ISO 27001.
What does an ISO 27001 IT audit assess?
An ISO 27001-compliant IT audit evaluates the entire information security management system: risk assessment processes, implemented technical controls (Annex A), management oversight, incident response, business continuity, and supplier security.
Is ISO 27001 mandatory in the pharmaceutical and medical technology industries?
ISO 27001 is not directly required by law. However, regulatory requirements for information security measures are mandated by GMP Annex 11, FDA 21 CFR Part 11, and—for medical devices—by the FDA Cybersecurity Guidance and MDCG 2019-16.
How does an IT audit differ from a GMP audit?
A GMP audit evaluates quality systems, documentation, and processes with regard to patient safety. An IT audit focuses exclusively on information security (networks, access rights, data security, cyber resilience). Computer System Validation (CSV) serves as the bridge between the two.
What are the critical IT security risks in the pharmaceutical industry?
The main risks include ransomware attacks on OT/SCADA systems (production downtime), loss of clinical data (regulatory risk), phishing attacks on QA/RA teams, and inadequately secured third-party cloud applications (SaaS).
Related topics.
Expertise
Computer System Validation
Ensuring GMP compliance of IT systems (Annex 11).
ExpertiseData Integrity Assurance
Ensuring compliance with the ALCOA+ principles for sensitive data.
ExpertiseISO Audit Consulting
Preparation for traditional QMS audits in accordance with ISO 9001 and ISO 13485.
Close your IT security gaps.
Whether you have an upcoming supplier audit or are proactively preparing for ISO 27001 certification, we’ll discuss your IT risks during a no-obligation initial consultation