CYBERSECURITY AND NIS2

Cybersecurity and NIS2 compliance

The NIS2 Directive (EU 2022/2555) strengthens the European cybersecurity framework and imposes regulatory obligations on organizations operating in sectors classified as “essential” or “important.”

Adeodata supports all clients, whether in the life sciences sector or not, on their path toward NIS2 compliance, starting with a Cybersecurity Governance Gap Analysis and then designing and implementing a set of security procedures and workflows that consistently incorporate the Directive’s requirements.

NIS2/GxP multi-compliance

Much of the content covered by NIS2 has been part of GxP (Good Manufacturing Practices) for years and is already addressed by GAMP 5 (Second Edition). That is why we recommend that life science companies adopt an integrated approach to managing these two regulations, which share several common elements.

In terms of documentation, life science companies can therefore adopt a single, harmonized approach capable of simultaneously meeting the GxP requirements of GAMP 5 and the cybersecurity requirements of the NIS2 Directive.

Thanks to its extensive experience in the life sciences sector, Adeodata supports clients through every stage of the journey toward NIS2/GxP multi-compliance, providing a team of specialists in GxP and cybersecurity, as well as a dedicated project management team to coordinate and oversee the entire project.