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.
NIS2 for Pharma & Life Sciences, in three questions
Yes — manufacturing pharmaceuticals and medical devices is an “other critical” sector under NIS2 Annex II.
Important / essential entity · NIS2 (Manufacture of pharmaceuticals & medical devices)
Manufacturers of medium size and up are Important entities. This sits on top of your existing GxP obligations, not instead of them.
NIS2 generally applies from medium-sized up — broadly 50+ staff, or annual turnover / balance-sheet total over €10M. (Medium is under 250 staff and up to €50M turnover or €43M balance sheet; larger than that is a “large” entity.) Some entities are in scope regardless of size, and the exact rules are set by your country’s transposition.
Register with your national competent authority once the transposing law applies.
Put the ten cybersecurity risk-management measures in place — and be able to show them working.
Report significant incidents: a 24-hour early warning, a 72-hour notification, and a final report within a month.
Your management body approves and oversees the measures — and can be held personally liable.
Scope is ultimately set by your national transposition — use the self-checks above, or ask us to confirm against your estate.
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.