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IT Governance ISO 27001 / ISMS Microsoft 365 GMP / Annex 11

IT Governance & Life Science Quality

A structured and auditable governance framework aligned with ITIL / ISO 27001, tailored to Life Science environments: define, deploy, monitor, and continuously improve — with full traceability and operational oversight.

Optional: audit preparation • KPI governance • documented procedures & traceability (ISO 27001 / GxP).

What the service covers

Operational governance, compliance, and audit readiness — tailored to regulated environments.

ISMS & ISO 27001

Design, deployment, and continuous improvement of an ISO 27001-aligned ISMS, integrating risks, controls, and business requirements.

  • Risk assessment (EBIOS / ISO)
  • Policies, procedures & governance
  • KPIs, internal audits, management reviews
  • ISO 27001 certification preparation

Microsoft 365 in regulated environments

Bringing Microsoft 365 (Intune, SharePoint, Exchange) under control with security, traceability, and document governance.

  • Access & identity governance
  • Controlled document management
  • Securing collaborative usage
  • ISO / GxP alignment

GMP, Annex 11 & GxP requirements

Support for computerized systems subject to GMP, Annex 11, inspections, and audit expectations.

  • Audit-oriented documentation
  • Change & incident management
  • Traceability & operational control
  • Audit / inspection support

A pragmatic, audit-oriented approach

NetQualIT relies on proven methodologies (PDCA, ITIL, ISO) to build an operational, measurable, and truly audit-ready IT governance framework — far from purely theoretical or documentation-driven approaches.

PDCA ITIL / ITSM ISO 27001

Engagements in inspectable (GxP) environments, internal audits, and ISO 27001 pre-certification support — with evidence-driven documentation and pragmatic governance.

The PDCA cycle applied to your governance

A PDCA (Plan • Do • Check • Act) approach tailored to Life Science environments — supported by ITIL-aligned operations, traceability, and measurable governance.

PLAN

Scoping, audit, governance design, risk assessment and prioritization.

DO

Implementation: Microsoft 365, Intune, SharePoint, processes and security controls.

CHECK

Controls, KPIs, internal audits and preparation for external audits.

ACT

Continuous improvement, CAPA, optimization and sustainable governance.

Who is this service for?

Organizations where compliance, traceability, and auditability are non-negotiable.

Pharmaceutical
& biotechnology industries
Laboratories
& Life Science organizations
SMEs & mid-sized companies
in regulated environments
Governance structuring
or ISO 27001 certification

Facturation électronique 2027

Un projet qui combine conformité réglementaire, transformation digitale et maîtrise documentaire.

Audit & préparation

Évaluation de votre organisation, de vos flux et de vos outils afin d'anticiper les impacts de la réforme et construire une trajectoire réaliste.

  • Cartographie des flux de facturation
  • Analyse ERP, comptabilité et Microsoft 365
  • Identification des écarts et risques projet
  • Plan d'action et feuille de route

PDP & intégration

Sélection et déploiement de la plateforme de dématérialisation partenaire (PDP) adaptée à votre environnement et à vos processus métier.

  • Choix de la plateforme adaptée
  • Intégration au système d'information
  • Interopérabilité avec les outils existants
  • Coordination éditeurs et parties prenantes

Gouvernance documentaire

Mise sous contrôle des documents, validations et preuves associées afin de garantir traçabilité, conformité et auditabilité.

  • GED et classement documentaire
  • Archivage électronique
  • Workflow d'approbation des factures
  • Procédures et modes opératoires

Vous souhaitez évaluer l'impact de la réforme sur votre organisation ? Découvrez notre guide pratique ou échangeons sur votre projet de préparation à la facturation électronique.

Let’s discuss your IT governance

A short discussion to clarify your needs, regulatory context, and define a simple, audit-ready roadmap.