Validated systems. Deployed AI. Fewer audit findings.
Independent IT consulting for pharma, biotech and medtech — based in Skåne, working across the Nordics.
MSET sits at the intersection of regulated IT and emerging technology. We validate systems. We deploy AI with the audit trail regulators expect. We run IT through inspections. We don't sell software — we design what you need and help you run it.
Computer system validation, qualification, eQMS rollouts, and ongoing compliance. Built on GAMP 5.
See services 02 / AIStrategy, validation and governance for AI and ML — built to hold up under inspection.
See services 03 / SecuritySecurity awareness training, phishing simulation, access control, and backup — the human and technical layers together.
See services 04 / LeadershipInterim IT Director, independent assessments, and multi-year IT roadmaps for regulated environments.
See servicesEvery regulated IT system you run eventually meets an auditor. We design, implement, and document systems so that meeting is uneventful — with rigorous computer system validation built on GAMP 5, 21 CFR Part 11, and EU Annex 11.
End-to-end validation for GxP systems — user requirements through to performance qualification, using risk-based approaches that satisfy regulators without over-engineering.
Electronic records and electronic signatures, done properly. Audit trails, access controls, and data integrity across the ALCOA+ framework.
Selection, configuration, and rollout of electronic quality systems — deviations, CAPAs, change control, training, and document lifecycle in one validated platform.
Periodic review, change control, and decommissioning. Validated systems don't stay validated by themselves — they need maintenance built into operational reality.
Deploying AI in a life-science company is fundamentally different from any other industry. We understand the validation requirements, the data governance expectations, and the regulatory scrutiny that comes with it — and we help you navigate all of it.
Deep dive: AI Consulting servicesPragmatic AI strategies tailored to your regulatory context, data maturity, and organisational readiness.
AI and ML systems implemented with the rigour of GxP — covering model validation, explainability, and audit readiness.
From AI-assisted document review and deviation analysis to intelligent batch release — practical applications with compliance built in.
Frameworks for responsible AI adoption — ensuring your teams, processes, and regulators are all aligned.
Over 90% of successful cyberattacks begin with a phishing email. Firewalls and antivirus software cannot protect against an employee who clicks the wrong link — but training and testing can.
MSET helps life-science and regulated organisations build a culture of security awareness — combining hands-on phishing simulations with structured Security Awareness Training that actually changes behaviour.
Deep dive: Security Awareness Training programmeRegulated sectors including pharma and medtech are among the most targeted globally — high-value IP and patient data are prime targets. Sources: Verizon DBIR 2024 · IBM X-Force Threat Intelligence Index · ENISA Threat Landscape
We run realistic, controlled phishing campaigns against your organisation — measuring who clicks, who reports, and who is most at risk. Results feed directly into targeted training.
Your people are your perimeter. Our role-based SAT programme turns employees from the weakest link into your first line of defence — with curriculum tailored to life-science and regulated work, and evidence your auditors will actually accept.
Develop and maintain IT security policies that satisfy both regulatory requirements and practical operational needs — aligned with ISO 27001, NIS2, and sector-specific expectations.
The right people in the right systems — and no-one else. Especially critical in GxP environments where access to validated systems must be documented and controlled.
We deploy and manage Acronis Cyber Protect — an integrated solution combining backup, ransomware protection, and endpoint security. Your data stays safe even when attackers get through.
Many organisations know their IT needs work — but lack the internal resource or independent perspective to define what good looks like. MSET provides that outside eye: honest assessment, clear priorities, and a practical roadmap to get you there.
When you need senior IT leadership now — during a transition, a growth phase, a restructuring, or simply a gap between permanent hires — MSET steps in as your Interim IT Director. Experienced, vendor-neutral, and immediately effective.
Available part-time or full-time, embedded with your leadership team, accountable for outcomes.
Active engagements
Interim IT Director
Life Science — Nordic
IT Steering — Quality & Tech
Medtech Group — Sweden
Interim IT Director
CRO Partner — Europe
Typical engagement structure
An objective, outside-in review of your entire IT landscape — infrastructure, security posture, systems, processes, and team. No vendor agenda. No internal politics. Just an honest picture of where you stand and what needs attention.
Translate your business goals into a concrete, prioritised IT strategy with a multi-year roadmap — covering systems, infrastructure, security, compliance, and capabilities. Built to survive contact with reality.
MSET (Mjukvara som en tjänst) is an independent consultancy based in Skåne, Sweden, operating as Kifarkis Nätsäkerhet. We combine hands-on technical experience with a pragmatic understanding of what it takes to work inside a regulated industry.
We work directly with quality, IT, and operations teams to deliver solutions that hold up under regulatory scrutiny — and serve the people using them every day.
Technology in life science should enable better science — faster, safer, and fully compliant. That's the standard we hold ourselves to on every engagement.
Deep, practical experience with GMP, GCP, and GLP environments across pharmaceutical, biotech, and medtech organisations.
Hands-on expertise deploying AI and ML tools in organisations where compliance is non-negotiable.
We recommend what's right for your situation — not what earns a commission. Honest advice, practical solutions.
Headquartered in southern Sweden, working with clients across the Nordics and wider Europe.
Life-science IT is our home — pharma, biotech, medtech, CRO/CMO, diagnostics, gene therapy. The same principles apply wherever compliance, audit trails, and system validation matter.
We're at our best when you'reExperience
15+
Years in regulated IT & life-science consulting.
Industries
6
Pharma, biotech, medtech, CRO/CMO, diagnostics, gene therapy.
Frameworks
8+
GAMP 5 · Part 11 · Annex 11 · ISO 27001 · NIS2 · ISO 14971 · GMP · GCP.
Independence
100%
Vendor-neutral advice. We partner where it serves you.
Whether you're planning a system validation, exploring AI possibilities, need an interim IT leader, or want an expert second opinion — we'd love to hear from you.
Location
Skåne, Sweden
info@mset.se
Web
www.mset.se
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