How do life sciences companies secure their information systems to ISO/IEC 27001 without losing sight of their GxP and cybersecurity obligations?
We assess your information security in a structured way against ISO/IEC 27001 and the life sciences specific risks across pharma, biotech, MedTech and IVD, expose gaps in access management, incident response and data backup, and support the build-up of a robust ISMS through to certification. The decisive weak point is rarely the standard itself, but the demarcation: the gap that becomes visible during inspection arises exactly where ISO/IEC 27001 ends and the regulatory controls required by EU GMP Guide Annex 11 and 21 CFR Part 11 begin.
- Pharma
- Biotech
- MedTech
- IVD
Overview
Why is information security particularly critical in life sciences?
IT audits & ISMS build-up for pharma, biotech, MedTech & IVD · ISO/IEC 27001, GMP Guide Annex 11, 21 CFR Part 11
Last updated: 2026-06-13
Life sciences companies are highly attractive targets and are at the same time subject to strict regulatory oversight of their IT systems. Clinical data, marketing authorisation dossiers and intellectual property carry high value, while GxP relevant systems must be demonstrably controlled in line with EU GMP Guide Annex 11 and 21 CFR Part 11. Four levers where programmes most often get stuck:
- Data and IP as an attack target: Clinical data, marketing authorisation dossiers and study results are high-value targets for ransomware and industrial espionage. A loss endangers not only operations but also data integrity, which must remain demonstrable under 21 CFR Part 11 and EU GMP Guide Annex 11.
- OT and production systems: GMP critical production and control systems (OT/SCADA) have grown over time and are often not hardened against modern cyberattacks, even though they fall within the scope of EU GMP Guide Annex 11.
- Regulatory pressure for medical devices: MDR (EU) 2017/745 and IVDR (EU) 2017/746 require explicit cybersecurity evidence for connected products; MDCG 2019-16 and IEC 81001-5-1 set out the detailed expectations across the entire product life cycle.
- Supply chain requirements: Large customers and partners increasingly make ISO/IEC 27001 certification a contractual prerequisite; at the same time, GxP obligations call for a documented assessment of IT service providers and cloud vendors.
Services
How we support you
IT security audit & gap analysis
Structured IT audit against the requirements of ISO/IEC 27001 and life sciences specific IT risks. We assess network architecture, access management, incident response and data backup concepts and deliver a prioritised findings report with an action list.
ISMS implementation to ISO/IEC 27001
Build-up of a complete information security management system: risk assessment, security policy, asset management, access control and business continuity, mapped against the controls in ISO/IEC 27001 Annex A. The result is a certification-ready ISMS including a Statement of Applicability.
Cybersecurity for medical devices
Consulting on the cybersecurity requirements arising from MDR (EU) 2017/745 and IVDR (EU) 2017/746 as well as MDCG 2019-16 and IEC 81001-5-1. We integrate the security activities demonstrably into design controls and risk management to ISO 13485.
Learn more →IT supplier & cloud assessments
Auditing of IT service providers and cloud vendors against ISO/IEC 27001 and GxP requirements. We assess the information security of SaaS solutions for eQMS, LIMS and other regulated applications and deliver a documented supplier assessment report.
Learn more →Inspection & certification readiness
Preparation for the ISO/IEC 27001 certification audit and for GxP inspections of computerised systems. We run mock audits, close open findings and establish consistency between ISMS evidence and CSV documentation.
How we work together
What it comes down to
In life sciences, information security is not a standalone IT topic but hinges on three requirements that have to fit together, and in this order: the ISMS scope under ISO/IEC 27001 determines which systems are considered at all. The risk assessment decides which Annex A controls are applicable and justified in the Statement of Applicability. And the GxP controls from the EU GMP Guide Annex 11 and 21 CFR Part 11 define which of these systems must additionally be demonstrably validated and audited. Draw the scope too narrowly and you lose exactly the OT and SaaS systems as a blind spot, which are the first to surface during inspection.
This is precisely where we come in: the gap analysis makes visible at the outset where ISO/IEC 27001 and the GxP obligations overlap, before controls are implemented and suppliers assessed. For connected medical devices, the early anchoring of the cybersecurity requirements from MDR (EU) 2017/745, MDCG 2019-16 and IEC 81001-5-1 in design controls and risk management to ISO 13485 is added. This shifts the effort forward, to where corrections are cheap, rather than into the certification or inspection audit, where a gap between ISMS evidence and CSV documentation sets the programme back.
Our approach
Our approach
Step
Result
Scope & risk analysis
Defined ISMS scope and risk inventory: which systems are GxP relevant, which fall under ISO/IEC 27001, and where the requirements overlap.
Gap analysis
Findings report with a prioritised action list against ISO/IEC 27001 Annex A and against the requirements of EU GMP Guide Annex 11 and 21 CFR Part 11.
ISMS build-up
Implemented policies, risk treatment plan and Statement of Applicability; Annex A controls implemented and supported by evidence.
Supplier & cloud assessment
Documented assessment of IT service providers and cloud vendors for eQMS, LIMS and SaaS systems, ready to feed into GxP supplier qualification.
Mock audit
Trial audit with findings, closed gaps and documentation checked for consistency ahead of the certification or inspection date.
Certification & operation
Supported ISO/IEC 27001 certification audit and an ISMS in live operation with internal audit and management review.
Common pitfalls
Where projects commonly fail
The ISMS scope and the GxP scope are not aligned.
Treating ISO/IEC 27001 in isolation overlooks the fact that the same systems are simultaneously subject to the control requirements of EU GMP Guide Annex 11 and 21 CFR Part 11. During inspection, the disconnects between ISMS evidence and CSV documentation come to light.
OT and production systems are left out.
SCADA and control systems are treated as pure plant engineering and are not included in the ISMS risk assessment and asset management, even though they are GMP critical and must be controlled as computerised systems under EU GMP Guide Annex 11.
The Statement of Applicability under ISO/IEC 27001 is completed as a formality.
If Annex A controls are flagged as applicable or not applicable across the board, without tying the rationale to the actual risk assessment, nonconformities arise in the certification audit because the evidence for the individual control is missing.
Cloud and SaaS vendors are ticked off on the basis of the provider's certificate.
A submitted ISO/IEC 27001 certificate does not replace your own documented assessment of the responsibility split and the GxP relevant functions that matter for eQMS or LIMS. GxP supplier qualification requires your own evidence.
Cybersecurity for medical devices is planned in only after the design phase.
If the requirements of MDR (EU) 2017/745, MDCG 2019-16 and IEC 81001-5-1 are not anchored early in design controls and risk management to ISO 13485, the evidence across the product life cycle is missing, and the gap becomes visible in the conformity assessment procedure.
FAQ
Frequently asked questions
Sources
- ISO/IEC 27001 - Information technology, Security techniques, Information security management systems, incl. Annex A
- EU GMP Guide Annex 11 - Computerised Systems
- FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures (primary text)
- Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) - primary texts
- MDCG 2019-16 - Guidance on Cybersecurity for medical devices
- IEC 81001-5-1 - Health software and health IT systems safety, effectiveness and security
- https://theentourage.de/expertise/it-audits-iso-27001/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- ISO/IEC 27001 (Information Security Management System)
- ISO/IEC 27001 Annex A (Controls)
- EU GMP Guide Annex 11 (Computerised Systems)
- FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
- MDR (EU) 2017/745 (Medical Device Regulation)
- IVDR (EU) 2017/746 (In Vitro Diagnostic Regulation)
- MDCG 2019-16 (Guidance on Cybersecurity for medical devices)
- IEC 81001-5-1 (Health software - Security activities in the product life cycle)
- ISO 13485 (QM system for medical devices)
- ISO 9001 (Quality management systems)
Related topics
Computer System Validation →
GxP control of computerised systems under EU GMP Guide Annex 11
Data Integrity Assurance →
ALCOA+ and data integrity as the bridge between ISMS and GxP
Audits & QA for IT Systems →
Supplier and cloud assessments for regulated IT systems
Cybersecurity Embedded Systems →
Cybersecurity for connected medical devices to MDCG 2019-16 and IEC 81001-5-1
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