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Information security management and data protection in the pharmaceutical industry

In the highly sensitive pharmaceutical industry, data protection, patient safety, product quality, and data integrity are top priorities. In light of increasing cyber threats, a professionally implemented information security management system (ISMS) is no longer a luxury, but an absolute necessity. On this page, you will learn how pharmaceutical companies can protect their sensitive data, comply with legal requirements, and create sustainable competitive advantages through the right management system.

Why information security and data protection are so important in the pharmaceutical industry

  1. Trust and compliance
    • Pharmaceutical and biotech companies process a large amount of highly sensitive patient data and research information that falls under the GDPR (General Data Protection Regulation).
    • Systematic risk management in accordance with ISO 27001 and the implementation of BSI IT baseline protection minimize data loss and ensure legal compliance.
  2. Security for critical infrastructures
    • Under the IT Security Act, pharmaceutical companies are often considered KRITIS operators, which means they are required to implement enhanced security measures.
    • The B3S Pharma (industry-specific security standard) was developed specifically for the pharmaceutical industry and is recognized by the BSI as fulfilling industry-relevant security requirements.
  3. Process optimization
    • A professional IT security strategy creates clear structures and processes, reduces internal risks, and automates compliance tasks.
    • This not only increases the level of protection—it also makes your company more efficient and cost-effective.

B3S Pharma: The industry-specific security standard

B3S Pharma is at the heart of information security in the pharmaceutical industry. It was developed by leading industry associations to:

  • adapt ISMS requirements specifically to the pharmaceutical sector,
  • establish consistent IT risk management, and
  • implement targeted emergency plans and business continuity management (BCM) concepts.

 

It is an indispensable foundation, especially for KRITIS operators, for securely and comprehensively meeting the requirements of the Federal Office for Information Security (BSI).

QSEC – The integrated management system for your pharmaceutical processes

An integrated solution such as QSEC is ideal for mapping all requirements for data protection, information security, risk management, and BCM in a single system. This management system was developed specifically for companies looking for a central platform for all relevant standards:

  • GDPR compliance: Automated documentation and evidence.
  • ISO 27001: Seamless implementation of guidelines, processes, and controls.
  • B3S Pharma: Specific requirements for pharmaceutical companies that must meet KRITIS requirements.
  • Extended standards (e.g., ISO 9001, ISO 14001, ISO 20000): Benefit from a single, scalable platform that efficiently covers multiple standards.

Ensuring compliance security

The strict requirements of TISAX, ISO 27001, and other standards leave little room for error. QSEC guides you step by step through all relevant compliance requirements and ensures that measures are fully documented and stored in an audit-proof manner.

Your advantages at a glance

Efficient audit preparation

Save time and stress by being fully prepared for TISAX and ISO 27001 audits thanks to QSEC.

Holistic management

Benefit from an integrated approach that combines data protection, risk management, and compliance in a single software solution.

Increased transparency

Keep track of the current status of your ISMS processes at all times and identify areas for action before they become a problem.

Sustainable organization

Reduce friction within your team, standardize processes, and establish a long-term safety culture.

What our customers say

  • In summary, we are very satisfied with the performance of QSEC and will continue to develop and use the software intensively in the future. The manufacturer of the software, Nexis GRC, is a reliable partner for us, always providing us with the best possible support thanks to its decades of experience in implementing global GRC and ISMS projects.
    Dr. Paul-Martin Steffen, Head of Data Protection and Information Security, DSW 21 Dortmunder Stadtwerke AG

  • In the end, QSEC was convincing in the cost-benefit analysis and in terms of scalability as a single-source tool. QSEC supports the dissemination of a uniform understanding of processes. The system acts as a central platform in which all business processes are recorded.

    Marcel Reifenberger, Chief Information Security Officer & CSO, CANCOM SE
  • In Nexis GRC, we have found a partner that speaks our "language" and responds openly to our requirements and ideas. The partnership with Nexis GRC has convinced me throughout the entire duration of the collaboration.
    Thomas Prigge, Information Security Officer, HanseMerkur Krankenversicherung AG
  • Auditing our infrastructure has become much easier and more efficient with the support of QSEC. Based on the auditors' positive assessment of the system's performance, we will continue to expand QSEC in line with our requirements.
    Hardy Krüger, Data Protection Officer, Information Security Officer and Head of Document Management, Harzklinikum Dorothea Christiane Erxleben GmbH
  • The methods and processes already integrated in the standard QSEC have significantly supported us in the professional development and operation of our information security management system. The maturity assessment and development enable us to continuously operate, monitor and further develop our Techem ISMS with QSEC in a resource-saving manner.
    Sebastian Fingerloos, Head of Information Security, Techem GmbH

ISMS, GRC, and data protection software QSEC:

QSEC – the information security management system (ISMS)

ISMS with QSEC means complete support for all processes relevant to information security management in accordance with the requirements

  • of ISO 27001 and/or
  • BSI IT-Grundschutz,

including the implementation of data protection requirements in accordance with GDPR.

 

This allows you to plan your information security management on a daily basis

  • plan (Plan)
  • implement (Do)
  • check (Check) and
  • improve (Law)

 

The ISMS tool QSEC guides users methodically and clearly through all task areas with workflow, wizard, and task support, and helps with the cost-saving and resource-optimized implementation of information security management through extensive content and best practices.

Selected
success stories

DSW21 on the successful introduction of an Information Security Management System (ISMS) with QSEC

Read success story

Cancom on the global introduction of an Information Security Management System (ISMS) in accordance with ISO/IEC 27001 with QSEC

Read success story

Techem on the challenges and experiences in information security and risk management with QSEC

Read success story

Harzklinikum Dorothea Christiane Erxleben on software-supported security management in accordance with B3S Health, ISO 27001 and GDPR with QSEC

Read success story

HanseMerkur on the development of a holistic management system taking into account the insurance law aspects according to VAIT

Read success story

Take action now: Take the next step with QSEC!

Rely on holistic information security management that meets your requirements - QSEC is a reliable partner at your side.

Request a live demo:

Experience QSEC in action and let us show you how our ISMS software solves your challenges.

Download ISO 27001 checklist:

Find out which steps are crucial for a successful information security management system.

Upcoming expert meetings

Grundschutz++ in 20 minutes: the BSI's next step
Date: October 29, 2025 | 4:00 p.m.

In this compact live session, Jonas Link will take you on a clear and practical introduction to the new Grundschutz++. He will show you how the requirements have fundamentally changed, what advantages the new must/should/can structure brings and why Grundschutz++ will replace the previous IT Grundschutz.

What to expect:

  • The most important differences to the previous IT baseline protection

  • The new focus on target objects instead of classic building blocks

  • Clear reduction and structuring of requirements

  • Outlook: Transition periods, next steps and practical experience