IT Governance & Quality in Life Sciences
NetQualIT supports organisations in their ISMS, Microsoft 365, ISO 27001 compliance and operational excellence initiatives.
Our Services
ITIL-aligned execution (incidents / service requests / change management) for controlled, measurable and auditable operations.
IT Governance & Quality
ISMS structuring, Microsoft 365 governance, ISO 27001 compliance and support for Life Sciences regulated environments.
IT Managed Services
User support, monitoring, Microsoft 365 security and structured change management within a documented and controlled framework.
Our Method
A PDCA (Plan • Do • Check • Act) approach tailored to Life Sciences environments: structure, deploy, verify and continuously improve — with full traceability and governance control.
Scoping, audit, governance framework, risk assessment and prioritisation.
Implementation: Microsoft 365, Intune, SharePoint, process design and security hardening.
Controls, KPIs, internal audits and preparation for external audits.
Continuous improvement, CAPA management, optimisation and sustainable governance.
Our Expertise
Practical, auditable and run-oriented expertise for demanding and regulated environments.
ISMS & ISO 27001
Risk assessment, governance framework, internal audits, certification readiness and evidence management.
Microsoft 365 & Security
Intune, SharePoint, Microsoft 365 compliance, security hardening, data protection and governance.
Life Sciences Quality
Annex 11 / GMP, audit trails, document management, validation and audit-ready regulatory environments.
A Trusted Partner
Life Sciences experience, IT governance and regulatory quality — a pragmatic, audit-ready approach inspired by PDCA.
Information Security & Compliance Lead (SPOC)
- Definition and maintenance of the Information Security Policy, procedures and associated controls.
- Risk / threat / impact assessment, decision support and prioritization.
- Awareness programs, training, security charter and control enforcement.
- Support for computerized systems compliance (GxP) and data protection requirements.
IT Project Lead — GxP-Compliant Document Management
- Project reframing (document management best practices, GxP requirements, business needs).
- Structuring: document taxonomy, classification plan, metadata attributes.
- Gap analysis against EU/US regulations (Annex 11, 21 CFR Part 11, etc.).
- Approach: assessment → interviews → consolidation → roadmap & deployment trajectory.
MES / Electronic Batch Record Project Lead
- End-to-end design & delivery leadership (planning, milestones, risk management, governance).
- Coordination between site and global teams, system integration across production units.
- Project communication and change management.
- Definition and monitoring of performance indicators (KPIs) and reporting.
CSV Program & Methodology Governance
- Administration and governance of a Computerized System Validation methodology.
- Management of an IT methodology framework (documentation, standards, dissemination).
- Audit-ready approach: traceability, evidence management, reviews and continuous improvement.
- Cross-functional support and alignment of practices across a broad scope.
Talk to an expert
Audit, governance, managed services, security or quality — let’s discuss your context, constraints, and priorities clearly and efficiently.