IVTracer monitoring
ivtracer monitoring installation et controle
Ivtracer environement controlé
ivtracer monitoring environnemental
ivtracer monitoring bpf
NetCeler 20 ans
IVtracer logo

Environmental monitoring solution (EMS) IVTracer is fully compliant with GMP requirements for pharmaceutical monitoring

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A complete environmental monitoring solution (EMS)

Today, monitoring critical environmental parameters is one of the key aspects in pharmaceutical, cosmetic and chemical industries.

Manufacturers whose activities are subject to regulatory requirements have a wide range of needs:

Particle counts, quality of air or water, temperature pressure or hygrometry, etc. IVTracer is the perfect solution for monitoring and tracking every parameter in a wide range of critical pharmaceutical environments.

News

  • Achieving zero loss of GxP data - what needs to be done

    In a GxP context, the breakdown of traceability and the loss of environmental measures potentially lead to critical consequences for the activity.

    [...] Read more

    Published on March 26, 2018

  • Pharma highlights 2017


    [...] Read more

    Published on January 23, 2018

  • Evolution of an environmental monitoring system in a BPx context

    When choosing the installation of an environmental monitoring system (EMS), the analysis often focuses on budgetary aspects, regulatory compliance, data security, alarm notification and editable reports.
    But another important aspect often set aside concerns scalability...

    [...] Read more


    Published on October 04, 2017

  • Climatic chamber monitoring

    Climatic chambers, cryogenic equipment, ovens, freezers, refrigerators, used in a pharmaceutical environment require precise monitoring of temperature conditions. The temperature probes generally used allow to follow with a good accuracy the temperatures ranging from -200 ° C. to + 100 ° C. The most widely used technology today is the combination of a Platinum Resistance Thermometer (PT100) connected to a 4-20 mA current transmitter...

    [...] Read more

    Published on August 22, 2017

  • Monitoring of a water purified distribution loop

    Water is the most used utility in the pharmaceutical industry and mainly when preparing the vast majority of drugs. Different grades of water based on chemical and microbiological purity are required depending on the type of manufacture.

    [...] Read more

    Published on July 12, 2017

  • FMS Cleanroom Monitoring – GMP Compliant

    Cleanrooms are classified with different critical parameters. The most important is the number of particles per cubic meter/air volume unity.

    ISO 14644-11 is the standard used and expressed in cubic meters which were formerly standard US FED STD 209...

    [...] Read more

    Published on May 19, 2017

  • Is BMS (Building Management System) an appropriate response to the requirements of GMP monitoring ?

    During our missions, we are often exchanging with our industrial clients on the appropriateness of using a BMS to set up a monitoring system meeting the GMP requirements 21 CFR Part 11.

    Is it enough to put up a continuous measurement system to meet its obligations? If necessary to comply with regulatory requirements...

    [...] Read more

    Published on April 18, 2017

  • Automated measurements in controlled area (GMP)

    IVTracer is a GMP Compliant software for environmental monitoring used in different environments:

    Particle counting, quality of air or purified water, temperature, pressure or hygrometry...100% made by NetCeler’s team...

    [...] Read more

    Published on April 14, 2017

  • GMP Environmental Monitoring | ACCINOV - Customer Feedback

    Located in the heart of Lyon Biopôle, ACCINOV is an innovative biotechnology platform, offering a unique solution in Europe:

    A100% GMP compatible production labs, with medical supplies capabilities. ACCINOV chose IVTracer as preferred environmental monitoring software.

    [...] Read more

    Published on March 3, 2017

  • Clean room monitoring

    IVTracer is a tool that brings to an industrial site a veritable " monitoring infrastructure " fully compliant with GMP requirements. Once installed, it is very simple and inexpensive to evolve thanks to a strong technology for automatic diffusion in the system in any case of change.

    [...] Read more

IVTracer : Monitoring GMP Compliant

With secure access from any web browser (connected to an internal network or the Cloud), IVTracer ergonomics have been studied to respond simply and intuitively to the monitoring requirements of industrial environments.

monitoring et conformité, solution logiciel monitoring solution logiciel monitoring BPF solution logiciel

This thorough and easy-to-use solution has been designed for a low-effort, high productivity user adoption.

Designed and developed by NetCeler’s engineering team, IVTracer software architecture provides functionalities for:

  • guaranteeing the traceability chain from sensors all the way through the database
  • optimizing the control of manufacturing environments by means of periodical automatic measurements;
  • tracking data flows in real time
  • providing accurate and user-defined management of alarm triggers (alarms, pre-alarms, appearance and disappearance delays, hysteresis, high and low thresholds, etc..).
Monitoring GMP Compliant

Particularly suited to respond to regulatory constraints, the IVTracer solution meets the “critical parameter traceability” requirements for the validation of audits conducted by the National Agency for Medicines (NAM) or the Food and Drugs Administration (FDA).

Monitoring - Validation & Qualification (IQ, OQ, PQ)

Thanks to IVTracer configurability and because every project is unique, the software is easily adapted to satisfy specific industrial requirements.

Besides customized software add-ons to meet Customer’s specific requirements, NetCeler also offers engineering , installation, qualification and maintenance services.
Support services include project commissioning, optimization of the existing system and software updates. The net result is to maintain Customers’ EMS value over time.

Web interface - PLC - digital sensors - particle counts - GMP - 21 CFR PART 11 - FDA - Quality - EMS

Mastering the Measurement Environment

Mastering the Measurement Environment

Data collection from the field (e.g. sensors in the cleanroom)
Daily check of archived data integrity
Collection of 4-20 mA, 0,10V analog measurements and On-Off-Control inputs
Collection of static or mobile particle counters
Compatibility with new generations of Ethernet or wireless digital sensors (Radio, Wi-Fi)
Compatibility with all Modbus-based communication systems (recorder, CTM, etc…)

Mastering the Monitoring Environment and IT Infrastructure

Mastering the Monitoring Environment and IT Infrastructure

Secured data transmission and communication
Redundant servers
Self-running PLCs (for several days)
Generation of alarms driving warning lights on the field
Buffering of measurements and alarms at each level (PLC’s and servers) for several days

User-interaction

User-interaction

Alarms in case of deviations
Production environment monitoring
Real-time data display
Archived data display: Reports, trends, etc.
Compliance checks: audit trail, 21 CFR PART 11
Web application

Please read the datasheet

IVTracer: an integrated and coherent solution

The IVTracer system is a unique environmental monitoring solution: allowing the easy integration of measurements either coming from a new installation or coming from a site refurbishing with pre-existing devices.

Following the installation set-up, IVTracer evolutions and updates are straightforward, thanks to the capability of automatic pushing every changes into each system element. This also ensures the system consistency, at any given point in time, correct-by-construction.

For utmost efficiency, this infrastructure can be shared among various building or production sites, or central servers.
Each building must simply connect its measurement probes (wired or wireless), without any requalification of the main software. This represents a huge effort and therefore cost saving.

IVTracer is used today to monitor tens of thousands of probes for critical monitoring. At the same time, it is constantly evolving to satisfy Customer new requirements only, as it is a completely manufacturer-independent solution. This independence allows NetCeler to develop a solid, long lasting, flexible EMS solution, easy to maintain and upgrade.

OUR SERVICES

In order to support our Customers during the deployment and maintenance of IVTracer installations, NetCeler offers the following services:

IVtracer SERVICES
  • Existing installation audits
  • Technical implementation studies
  • Mapping services
  • Other studies based on our Field experience
  • Integration of existing equipment and/or deployment of new wired/wireless sensors
  • Project Management, with overall system installation and qualification, according to the current standards (FAT/SAT/IQ/OQ/PQ)
  • Post-installation support from a dedicated team, phone support and access to a secure web-portal to enter, browse tickets.

OUR REFERENCES

Our software is used by several pharmaceutical, cosmetic and chemical companies. Please find our references below :

sanofi
sanofi pasteur
zentiva
stallergenes greer
fareva
delpharm
accinov
genzyme
boehringer ingelheim
erytech

CONTACT

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Address :

NetCeler
5 avenue de la Gare
26300 ALIXAN
France

Phone :
+33 (0)4 92 57 12 12
E-mail :
contact@netceler.com

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NetCeler
Les Peyrons
05400 VEYNES
France

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