Products · Pharma & Life Sciences
Alexus for Pharma & Life Sciences
Pharma and medical-device manufacturers are in NIS2 scope, on top of an already audit-heavy GxP world. Alexus adds the operational-security evidence NIS2 wants without disturbing your validated environment.
Manufacture of pharmaceutical products and medical devices falls within NIS2 (important, and essential for critical players). GxP / GAMP 5 validation gives you quality evidence, not the cyber-risk-management and incident-reporting evidence NIS2 requires. Alexus fills that gap, alongside (not inside) your validated systems.
Complements GxP / GAMP 5 validation and supply-chain rules.
What makes NIS2 hard in Pharma & Life Sciences
Validated systems, frozen by design
GxP-validated environments resist change. Bolting a heavyweight compliance tool into them is risky and slow.
Sprawling supply chains
CDMOs, lab partners and logistics widen the attack surface, and NIS2 expects supply-chain security to be evidenced.
IP and continuity on the line
Research IP and uninterrupted production are existential. Incidents must be contained, resolved and proven defensibly.
The evidence layer, tuned for Pharma & Life Sciences
Operational evidence beside GxP
Alexus captures the cyber-risk and incident evidence NIS2 needs without touching the validated state of your GxP systems.
Supply-chain visibility
A live graph of systems and dependencies, including third-party integrations, so supply-chain risk is mapped, not assumed.
Article 23 incident reporting
Early-warning and full reports generated from the operational graph, ready for you to review and submit.
Accountability for the board
Quarterly evidence supporting Article 20 due diligence and cyber-insurance conversations.