IVTracer – Environmental Monitoring (EMS)

IVTracer

is the software solution for environmental monitoring in the pharmaceutical industry, GMP certified.

IVTracer

allows the centralisation of measurements in order to harmonise the monitoring of a pharmaceutical plant

IVTracer

is a complete monitoring solution that guarantees the right manufacturing conditions and alerts users of deviations in real time.

IVTracer

can be accessed from any web browser to meet monitoring needs
in a simple and intuitive way.

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IVTracer est la solution logicielle de monitoring environnemental en milieu pharmaceutique certifiée BPF/GMP qui permet de centraliser les mesures afin de garantir les bonnes conditions de fabrication et d’alerter les utilisateurs des déviations.

Accessible depuis tout navigateur web (connexion au réseau interne), l’ergonomie d’IVTracer a été étudiée pour répondre de manière simple et intuitive aux besoins de monitoring pour les industriels du secteur pharmaceutique.

IVTracer est une solution complète de monitoring qui offre une prise en main rapide et efficace.

21 CFR Part 11: Monitoring requirements

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Compliant with GxP and 21 CFR part 11 requirements, IVTracer is the solution to improve the monitoring of environmental parameters to ensure the safety and integrity of critical GMP measures.

IVTracer - Environmental Monitoring (EMS)

Particle counting

IVTracer - Environmental Monitoring (EMS)

Temperature

IVTracer - Environmental Monitoring (EMS)

Hygrometry

IVTracer - Environmental Monitoring (EMS)

Air quality

IVTracer - Environmental Monitoring (EMS)

Water quality

IVTracer - Environmental Monitoring (EMS)

Pressure

An interface to monitor many sensors 

Our pharmaceutical application sectors

IVTracer is an EMS (Environmental Monitoring System) currently used by many manufacturers in the pharmaceutical sector, for applications such as the production of injectables, production of dry forms, packaging, research, production of active molecules and medical diagnosis. IVTracer can be integrated in the production, storage or laboratory context.

PHARMA
BIOTECH
MEDICAL DEVICES
ANIMAL HEALTH
HOSPITALS
IVTracer - Environmental Monitoring (EMS)

Comptage de particules

IVTracer - Environmental Monitoring (EMS)

Qualité de l'air

IVTracer - Environmental Monitoring (EMS)

Température

IVTracer - Environmental Monitoring (EMS)

Qualité de l'eau

IVTracer - Environmental Monitoring (EMS)

Hygrométrie

IVTracer - Environmental Monitoring (EMS)

Pression

IVTracer - Environmental Monitoring (EMS)

Pression

IVTracer - Environmental Monitoring (EMS)

Hygrométrie

IVTracer : challenges of measurement traceability

The monitoring of critical environmental parameters is an indispensable aspect in the pharmaceutical industry and the medical field. Companies whose activities are subject to regulatory requirements have multiple needs:

  • To comply with regulatory requirements and standards such as ANSM (Annex 11), FDA (21 CFR part 11…) data integrity (ALCOA+)
  • To be able to comply with Good Manufacturing Practice (GMP) and Laboratory Practice (GLP) rules.
  • Protecting their most valuable raw materials
  • Ensure real-time non-contamination of production batches
  • Provide evidence of compliance in the event of an audit or disputes
audit-trail-courbe-historique-visualisation-ivtracer-monitoring-environmental

Our Monitoring Expertise

Our strategy based on expertise and innovation is at the heart of the IVTracer product, which since 1997 has made it possible to respond both to the problems of environmental control and to the challenges of technological evolution (ease of use, flexibility in the proposed architectures, integration of existing hardware, secure measurement / Data-Integrity, innovative concepts of industry 4.0 and compliance with the cybersecurity policy).

With a specialised team with a wide range of skills, the NetCeler team will support you throughout your project.

Audits & Studies

Audits & Studies

A precise analysis of your project

Innovation

Innovation

The continuous evolution of the product to meet needs

Project management

Project management

A turnkey solution and a controlled schedule

Qualification

Qualification

Our quality expertise (FAT/SAT, QI, QO, QP)

Support & Maintenance

Support & Maintenance

A dedicated team at your service

Audits & Études

Audits & Études

Une analyse précise de votre projet

Innovation

Innovation

L'évolution continue du produit pour répondre aux besoins

Gestion de projets

Gestion de projets

Une solution clef en main et un planning maîtrisé

Qualification

Qualification

Notre expertise qualité (FAT/SAT, QI, QO, QP)

Support & Maintenance

Support & Maintenance

Une équipe dédiée à votre service

Our clients

Since its creation IVTracer has been dedicated to environmental monitoring in clean rooms for major accounts in the pharmaceutical industry. 
Our clients trust us and allow us to provide a long-lasting solution. 

Find below our references: 

Our key figures

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Years of experience in industrial monitoring projects
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Measuring points collected with our IVTracer software
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Collaborateurs dynamiques aux valeurs fortes d'efficacité

Our EMS architecture

IVTracer - Environmental Monitoring (EMS)

Key advantages of the IVTracer solution

Safety and reliability

- Redundancy
- Bufferisation
- Integrity
- LDAP access rights
- Automated configuration

IT integration

- Web Interface
- VLAN, WAN
- Virtualization
- Data base
- E-mail

21CFR Part 11 compliance

- Electronic signature
- Audit trail
- Configuration review
- Magazine accès
- Validation

Compatible equipment

- Analogue sensors
- Digital sensors
- Ethernet PoE
- Wireless Radio/Wifi
- OPC-UA
- MQTT

Sécurité et fiabilité

- Flux de données redondant
- Rétention à chaque étage
- Garantie d’intégrité des données
- Politique de droits d’accès
- Identification via LDAP

Intégration informatique

- Interface Web et bureautique
- Intégration réseau (VLAN, WAN)
- Lien annuaire d’entreprise LDAP
- Virtualisation serveur
- Téléphonie et e-mail

Facilité de déploiement

- Diffusion de la configuration automatique
- Diffusion des programmes
- Configuration Excel
- Synchronisation différée
- Coûts de qualification réduits

Conformité 21CFR Part 11

- Signature électronique
- Audit trail des actions utilisateurs
- Audit trail de la configuration
- Validation des systèmes
- Rapport de fabrication

Matériels compatibles

- Sondes 4-20 mA / 0-10V / TOR
- Compteurs de particules
- Sondes radio, WiFi, Ethernet
- Sondes numériques Modbus
- Tout type de sonde sur demande