That is exactly where we start – not by proposing to patch the instrument, but with what carries the load instead: the unpatchable system moves into its own zone, gets controlled transitions instead of open network visibility, and monitoring notices when something there starts behaving like an attacker. We know the line between what quality assurance owns and what IT can own – and we work so that validation does not have to be reopened for every firewall rule.
The location fits: between Leverkusen, Wuppertal, Monheim, Hilden, and Düsseldorf lies one of the densest pharma and biotech clusters in Europe, and our office in Solingen sits in the middle of it. Before founding sector7, our owner was permanently employed in this industry – the interplay between qualification, quality assurance, and IT operations is familiar to us first-hand, not from a brochure.
What matters for Pharma & Biotechnology
- B-03Network & ConnectivityLab, production, building services, and office belong in separate zones – especially where qualified systems and legacy instruments stand that cannot keep pace. We plan and operate the segmentation so the unpatchable analyser stays reachable where it must be, and nowhere else.
- B-04Cyber Security & ProtectionResearch data, study documentation, and manufacturing instructions are the industry's capital and a rewarding target for industrial espionage as much as for extortion. We harden the perimeter, control access with a second factor, secure vendor remote maintenance, and run monitoring that flags anomalies early.
- B-06Business Continuity & ResilienceA production stoppage here costs more than revenue – potentially a batch and the chain of evidence behind it. Veeam-based immutable backups to geo-redundant targets of our own, tested recovery, and a rehearsed emergency plan – including the question of how a restore is documented in a validated environment.
- B-09Regulation & ComplianceWe establish which of your entities fall under NIS-2 – medicinal product manufacturers are covered directly within the health sector once the thresholds are met – and work against the measures catalogue. For the GxP side we supply the IT evidence your quality assurance needs for Annex 11 and data integrity; validation itself stays with you and your qualification partner.
- B-05Managed Services & SupportOperations with 24/7 monitoring, documented changes, and reports that feed your evidence – following the change procedure a validated environment requires, rather than the pace a standard ticket system imposes.
Annex 11 and NIS-2: two regimes, one infrastructure
EU GMP Annex 11 applies to computerised systems in a GMP environment: systems must be validated, access personal and traceable, data intact and recoverable across its lifecycle – the data integrity expectations usually summarised as ALCOA+. Anyone shipping to the United States faces a very similar expectation for electronic records and signatures under 21 CFR Part 11. In parallel, the German NIS-2 implementation act has applied since 6 December 2025 and covers medicinal product manufacturers in the health sector directly once the thresholds are met. The two regimes pursue different purposes – product quality here, security of supply there – but technically they reach for the same points: access control, logging, backup, recoverability. We build that once, properly, and deliver the evidence in both directions. What we do not do is validate your systems. That is your quality assurance's job, and we work alongside it rather than replacing it.