A complete environmental monitoring solution (EMS)
Today, monitoring critical environmental parameters is one of the key aspects in biotechnology, pharmaceutical, cosmetics and chemicals industries.
Manufacturers whose activities are subject to regulatory requirements have a wide range of needs:
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Being able to comply with GMP and GLP standards and other regulations to which they are subject, such as 21CFR part 11 for the pharmaceutical industry or the ISO 22716 standard in cosmetics,
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Protecting their most valuable commodities,
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Guaranteeing real-time non-contamination of manufacturing batches,
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Providing evidence of compliance with regulations for audits or disputes.
Particle counts, quality of air or water, temperature pressure or hygrometry, etc. IVTracer is the perfect solution for monitoring and tracking every critical parameter in a wide range of extreme environments:
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Clean rooms
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Cold roomss
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Climatic chambers
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Production lines
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Warehouses
IVTracer : Monitoring GMP Compliant
With secure, controlled access from any web browser (connected to an internal network or the Cloud), IVTracer ergonomics have been studied to respond simply and intuitively to monitoring requirements in industrial environments. This complete easy-to-use solution is designed to be taken in hand both rapidly and efficiently.
Designed and developed by NetCeler’s engineering team, software architecture provides functions for:
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guaranteeing the traceability chain from sensors through to databases,
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optimizing production environment control by means of regular automatic measurement,
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tracking data in real time,
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providing accurate management of alarm triggers (alarms, pre-alarms, appearance and disappearance times, hysteresis, high and low thresholds, etc…).
Particularly suitable for regulatory constraints,the solution meets the “critical parameter traceability” requirements needed for validating audits conducted by the National Agency for Medicines (NAM) or the Food and Drugs Administration (FDA).
Monitoring – Validation & Qualification (QI, QO, QP)
Because every project is unique, solutions are tailormade to meet industrialists’ individual requirements.
Besides customized development to meet specific requirements, NetCeler also offers engineering, installation, qualification and maintenance services.
Assistance services include project commissioning, optimizing system use, and permanently updating the system for maximum service life.
web interface – PLC – digital sensors – particle counts – GMP – CFR21PART11 – FDA – EMS
Controlled measurement
– Information collected in the field (sensors in the cleanroom)
– Integrity of archived data controlled daily
– Integrity of 4-20 mA, 0,10V analog measurements and On-Off-Control entry point
– Compatibility with new generations of Ethernet or wireless digital sensors (Radio, WIFI)
– Integrity of a static or mobile particle counter
– Compatibility with all Modbus communicating system (recorder, CTM, etc…)
Controlled systems
– Secured data transmission
– Redundant servers
– PLC capable of operating independently for several days
– Generation of alarms and light column management directly at the field level.
– Measurements buffering and alarms at each floor on several days (automaton and server)
User interaction
– Alarms for any anomaly
– Production environment monitoring
– Real-time data viewing
– Consultation of historical information: Reports, curves, etc.
– Compliance validation audit trail, CFR21 part 11
– Web application