You wouldn’t believe how many times, when trying to conduct a Risk Analysis in an organization, we’ve heard things like: “If we only think about the bad stuff, we’ll never get anything done,” “There’s no time to assess risks, we need to sell,”or the classic “We focus on goals, not risks… if something happens, we’ll fix it.” Needless to say, some of those organizations didn’t survive COVID.
Although global pandemics have always existed in threat catalogs, they were usually dismissed due to their low likelihood (like the meteor example: if a meteorite hits our organization, the impact is huge, but the probability is low—none of us have anti-meteorite missiles on the roof). Today, pandemics are a standard part of Risk Analyses (RA) and Business Impact Analyses (BIA), with countermeasures in place in case we can’t reach the office for any reason.
NIS2: Strengthening Cybersecurity in Critical Sectors
To bring some structure to this evolving landscape, the NIS2 Directive (Network and Information Security Directive) came into effect on October 17, 2024. Its goal is to strengthen cybersecurity across the European Union, directly impacting critical sectors such as the pharmaceutical industry.
This new version expands and improves on the original NIS directive, as recent reality has shown that many organizations in essential sectors still lack basic cybersecurity measures. These include continuous risk management, proper documentation and notification of security incidents, regular vulnerability assessments, and incident response and continuity plans—especially important in the face of increasingly frequent and sophisticated cyberattacks.
The core idea behind NIS2 is to broaden cybersecurity enforcement to more sectors (from the original 7 under NIS1 to 35 under NIS2), compelling many more organizations to comply with updated security requirements. Antivirus software and regular backups are no longer enough; now it’s about continuous risk management, advanced technical and organizational safeguards, and stricter penalties for non-compliance.
For the pharmaceutical sector, the directive applies to the entire value chain—from research and development to manufacturing, distribution, and storage. As the sector undergoes rapid digital transformation through the adoption of technologies like AI and connected production systems, its attack surface grows significantly. This makes the confidentiality, integrity, availability, and traceability of critical data more important than ever.
From Obligation to Strategic Opportunity
It’s important to understand that NIS2 doesn’t necessarily mean huge tech investments or inflated IT budgets. In reality, it promotes business resilience and efficiency by enforcing what should be seen as common-sense cybersecurity measures that many companies should have implemented years ago.
This directive shouldn’t be viewed as a burden but as a valuable opportunity to strengthen the resilience of pharmaceutical companies in an increasingly digital and risk-prone world. Cybersecurity is no longer just a technical issue or a cost—it’s a strategic pillar that can make the difference between business continuity and disruption during a crisis.
Additionally, GxP regulations not only require validation of systems but also qualification of the IT infrastructure that supports them—directly tied to both security and cybersecurity. Beyond being a regulatory requirement, this is an opportunity to enhance security, ensure data integrity compliance, and guarantee business continuity.
Qualipharma: Ready for What’s Next
At Qualipharma, we’ve been complying for years with the very standards that the NIS2 Directive now formalizes, ensuring resilience and cybersecurity across our operations.
If you’re not sure whether your organization meets the new requirements, we can help identify gaps, create a solid action plan for compliance, and support your IT infrastructure qualification.
Don’t let cybersecurity be a barrier—turn it into your competitive advantage with Qualipharma.