GAMP 5 is the guideline for ensuring the quality and compliance of automated systems in the pharmaceutical industry.

Summary:
NIS2 elevates cybersecurity to a top priority. This EU directive significantly widens the scope of affected companies and tightens obligations, deadlines, and liability risks. However, being well-prepared pays off: systematically managing risks and establishing clear reporting channels not only helps avoid severe penalties but also enhances the resilience and future viability of your company in the long run.
With NIS2, cybersecurity takes its rightful place in the executive suite. The new EU directive not only tightens the approach to information security but also significantly broadens the scope of affected companies. But what does this mean for you in concrete terms? We provide you with an overview: Who needs to take action? What are the deadlines? And how can you implement the requirements pragmatically?
The NIS2 Directive (EU 2022/2555) is the latest update on Europe's digital security. Its clear objective: to significantly enhance the cyber resilience of organizations in critical sectors.
NIS2 distinguishes between "essential entities" and "important entities." Whether you are affected depends on your industry and size.
Important: NIS2 goes far beyond the traditional KRITIS law. Many companies will face regulated requirements for the first time.
NIS2 requires not only security but also demonstrable risk management. It's no longer just about technology; documented processes are essential. The focus is on:
NIS2 demands much more than technical barriers - the directive calls for clear organizational and strategic steps. Cybersecurity becomes a top priority: Business leaders bear the responsibility for implementation, are accountable, and must always be aware of current risks. At the same time, knowledge becomes a crucial protective factor, as mandatory training for executives and employees instills awareness of dangers and reporting channels throughout the team.
This is based on a consistently risk-based approach. Measures are not aligned with theoretical models but with real threat scenarios and are regularly reviewed. External partnerships also come into focus: Collaborations with IT service providers require contracts that firmly establish security standards.
Additionally, the protection of sensitive data through encryption and physical security are included. In short, NIS2 demands a dynamic security management system that integrates technical, organizational, and strategic levels and continuously evolves.
During a security incident, time is of the essence, and deadlines are tight:
One thing is clear: violations of the NIS2 directive do not go unnoticed. The penalties are significant and can quickly become expensive. For "essential entities," fines of up to 10 million euros or 2% of annual global turnover are possible, whichever is higher. "Important entities" can face fines of up to 7 million euros or 1.4% of annual turnover.
However, the risk does not only affect the company as a whole. In cases of severe negligence, executives can be held personally liable. Authorities also have the power to impose conditions, order special audits, or even temporarily restrict the activities of those responsible. Do not view the reporting requirements as mere formalities, but as crucial tools to minimize financial and legal risks and to protect your good reputation.
The most common stumbling blocks are typically:
While NIS2 does not mandate a specific architecture, modern cloud and SaaS models can greatly reduce your workload. Why? Because updates, system hardening, and availability are often included in the service. The "shared responsibility principle" still applies, but you significantly reduce your operational risks.
Approach the topic systematically:
View NIS2 not as a bureaucratic burden, but as a strategic lever. Acting now not only minimizes regulatory risks but also ensures the sustainability of your company. In our complex industries, stability and resilience are the currency of tomorrow.
What is GAMP5? | Principles and more – Beitrag öffnen
GAMP 5 is the guideline for ensuring the quality and compliance of automated systems in the pharmaceutical industry.
Process validation of an ERP system – Beitrag öffnen
Learn how to validate your ERP system in line with GAMP5 and discover insights tailored to regulated industries.
What is GxP and who sets the guidelines? – Beitrag öffnen
GxP stands for “Good Practices” – a set of guidelines to ensure quality and compliance in the life sciences.