Skip to content

Pharmacy

The pharmaceutical industry requires innovative solutions to overcome complex challenges.

Our services for the pharmaceutical industry

Woman at a microscope

Customized services for the pharmaceutical industry

TÜV NORD offers the pharmaceutical industry a wide range of services focussed on safety, efficiency and compliance. Compliance with building regulations and plant safety are ensured through specialised testing and consulting. Certifications in accordance with ISO standards and specific safety standards support IT security and crisis management. Energy efficiency and document management are further focal points that are optimised through targeted certifications. Our services help to ensure the highest standards in the pharmaceutical industry and strengthen the market position of our customers.

All services for the pharmaceutical industry

A

Audit according to EFfCI

Certification of data centers according to TSI, EN 50600, or ISO/IEC 22237

The certification of data centers according to TSI, EN 50600, or ISO/IEC 22237 by TÜV NORD guarantees availability, security, and resilience. Since 2002, over 1,000 projects have been successfully completed, making certified data centers a reliable benchmark in Germany and internationally and creating trust among third-party users.

Certification of security requirements in accordance with IEC 62443-2-1 and -2-4

The IEC 62443 standard provides an internationally recognized standard for network security in the process and automation industry, which is increasingly used in Industry 4.0. It helps prevent cyberattacks and serves as proof of due diligence in accordance with the Industrial Safety Regulation and Product Safety Act.

Certification of technical control centers according to TSA.STANDARD

The certification of alarm receiving centers and technical control centers in accordance with TSA.STANDARD or EN 50518 by TÜV NORD guarantees maximum reliability. It provides objective proof of the effective implementation of technical, operational, and organizational requirements, including process control and plant monitoring centers, for precise control and monitoring.

Commissioning of data centers

TÜV NORD's commissioning of data centers includes integration tests that ensure the proper functioning of critical infrastructure such as power supply, climate control, and security systems. As a neutral third party, TÜV NORD provides quality assurance to ensure trouble-free operation and verify system interactions.

Conformity assessment and GAP analysis of alarm receiving centers and technical control centers

TÜV NORD's conformity assessment and GAP analysis of alarm receiving centers and technical control centers identifies risks and potential for improvement. It provides a snapshot of the current level of security and optimally prepares you for certification according to EN 50518 or TSA.STANDARD.

Conformity assessment of data centers

TÜV NORD's conformity assessment of data centers ensures physical security and availability through standards such as TSI, EN 50600, and ISO/IEC 22237. These provide comprehensive requirements definitions for power supply, climate control, building construction, and security systems, enabling companies to demand quality guarantees from colocation providers.

Design Assesment of data centers

TÜV NORD's planning assessment of data centers ensures compliance with standards such as TSI.STANDARD, EN 50600, and ISO/IEC 22237. Early review of the draft design allows for corrections to be made in the event of deviations, ensuring high availability classes and optimal structural and technical measures.

Document management systems: Examination & certification PK-DML

TÜV NORD offers testing and certification of document management systems (DML) to ensure audit-proof archiving. We examine technical and organizational aspects to meet legal requirements such as unalterable archiving and process traceability.

The TSA.STANDARD certification from TÜV NORD ensures maximum reliability for alarm receiving centers and technical control centers in accordance with DIN EN 50518. It confirms the effective implementation of technical, operational, and organizational requirements for the reliable reception and processing of emergency calls and alarm signals 24/7.

The European standard EN 50600 provides comprehensive guidelines for the planning, construction, and operation of data centers, focusing on power supply, air conditioning, and security infrastructure. TÜV NORD experts support you in designing your data center to be future-proof and state-of-the-art.

ISO 15378 Certification

ISO 22301 - Business Continuity Management System (BCMS)

The ISO 22301 standard for business continuity management systems (BCMS) helps companies ensure business continuity in the event of critical incidents such as natural disasters or IT failures. TÜV NORD CERT offers certification to ensure proactive measures and testing procedures for crisis management.

ISO 27001 Certification

The ISO/IEC 27001 standard defines criteria for an effective information security management system (ISMS) that ensures the confidentiality, integrity, and availability of data. TÜV NORD offers customized audits for certification to ensure trust and continuous improvement.

The international standard ISO/IEC 22237 provides comprehensive guidance on the planning, construction, and operation of data centers to ensure their physical security and availability. TÜV NORD experts support you in planning, operating, or expanding your data center in a future-proof manner in line with the latest state of the art.

KRITIS and the IT Security Act

The IT Security Act 2.0 extends the protection of critical infrastructures (KRITIS) to include municipal waste disposal and companies of particular public interest. It lowers thresholds to oblige more organizations to increase their IT security, especially those that serve more than 500,000 people.

Location assessment of data centers

The location assessment for data centers is crucial for security. Early identification and mitigation of risks such as water, explosions, and hazardous substances are essential. The location influences the level of security, whereby potential hazards and traffic routes must be taken into account to ensure optimal conditions.

Safe on the EU market: As a globally recognized notified body, we support you with the MDR certification of your medical devices. The Medical Device Regulation (MDR) sets the EU standards for the safety and quality of medical devices – we ensure that your products are compliant and market-ready.

MDSAP certification

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet the regulatory requirements of multiple markets with just one audit. Learn how TÜV NORD CERT can support you on your path to successful MDSAP certification.

Quality Gates & Construction guidance for Data Centers

TÜV NORD offers effective construction supervision to ensure the conformity and certifiability of high-availability data centers. Up to five on-site appointments during the construction phase allow deviations to be identified and corrected at an early stage, based on standards such as TSI.STANDARD, EN 50600, and ISO/IEC 22237, in order to avoid high costs for subsequent changes.

Supply chains & due diligence obligations

Since 2023, the Supply Chain Due Diligence Act has required organisations to protect human rights and environmental standards throughout their entire supply chain. Through risk management, preventive measures, and grievance mechanisms, violations can be identified and prevented at an early stage. Annual reporting ensures transparency

TSA.STANDARD: Physical protection of alarm receiving centers/technical control centers

The TSA.STANDARD from TÜV NORD is a comprehensive catalog of criteria for the certification of alarm receiving centers and technical control centers, based on DIN EN 50518. It ensures physical security and reliability, supplemented by additional features for functional safety. Continuous further development ensures conformity with the current state of the art.

TSE.STANDARD: Energy efficiency & sustainability in data centers

The TSE.STANDARD from TÜV NORD supports data centers in implementing energy efficiency and sustainability in accordance with the Climate Neutral Data Center Pact and the Energy Efficiency Act. It offers a modular system for compliance with EU directives and ISO 50001:2018 to demonstrate CO2 neutrality and sustainable operation.

TSI.PROFESSIONAL Training

The TSI.PROFESSIONAL training course from TÜV NORD offers comprehensive insights into the planning, construction, and operation of data centers, based on the TSI methodology and the TSI.STANDARD. It covers physical security, availability, and energy efficiency, based on BSI IT-Grundschutz and standards such as DIN EN 50600.

TSI.STANDARD: Availability & Physical Protection of Data Centers

TSI.STANDARD is a methodology developed by TÜV NORD for evaluating and certifying the physical security and availability of data centers. It offers a holistic approach that takes into account the physical infrastructure, organizational processes, and documentation to ensure high availability and security of the infrastructure.

Workshops for alarm receiving centers and technical control centers

The workshop for alarm receiving centers and technical control centers provides knowledge on assessment and certification in accordance with EN 50518 and TSA.STANDARD. It introduces the TSA methodology, explains requirements and test procedures, and offers an assessment of certifiability as well as space for project-specific questions.

Workshops for Data Centers

The workshop provides an overview of security standards for data centers based on TSI.STANDARD, EN 50600, and ISO/IEC 22237. Participants receive an assessment of certifiability, clarify project-specific questions, and learn details about test procedures and requirements.

The latest knowledge from the pharmaceutical industry

Eine Nahaufnahme eines Insekts auf menschlicher Haut

06/02/2025

Why are mosquitoes deterred by insect spray?

Chemical and process industry

Health sector

Public administration

Pharmacy

Article

Sustainability and environmental protection

#explore

3D-Visualisierung einer DNA-Doppelhelix mit leuchtenden molekularen Strukturen in Rosa und Blau. Der Hintergrund zeigt verschwommene blaue Bereiche, die eine wissenschaftliche Atmosphäre schaffen.

03/02/2022

Researching for a long and healthy life

Health sector

Pharmacy

Interview

#explore