Located in the heart of Lyon Biopôle, ACCINOV is an innovative biotechnology platform, offering a unique solution in Europe: 100% GMP compatible production labs, with medical supplies capabilities. ACCINOV chose IVTracer as preferred environmental monitoring software.
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Located in the heart of Lyon Biopôle, ACCINOV is an innovative biotechnology platform, offering a unique solution in Europe: 100% GMP compatible production labs, with medical supplies capabilities. ACCINOV chose IVTracer as preferred environmental monitoring software.
IVTracer is software product specifically developed to track critical environmental parameters for the pharmaceutical industry. It has been serving this market since 2001. IVTracer solution allows to track and control all critical parameters in the most diverse environments, such as clean rooms, cold storage rooms, conditioning cabinets, but also production chains and large warehouses. In the market for over 15 years, IVTracer was able to demonstrate its effectiveness and reliability in environmental monitoring with the biggest names in the pharmaceutical sector such as Sanofi, Stallergènes or bioMérieux. All these accounts can confirm IVTracer as THE solution: « IVTracer has truly been a solution fitting ACCINOV platform and our experience confirmed the initial assumption ». André Dupont stated. Mr. Dupont is ACCINOV Head Pharmacist, responsible for the site in Lyon. |
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As a pharma site, ACCINOV must comply to both Good Manufacturing and Laboratory Practices, but also 21CFR part 11 and Annex 11 of GMP. |
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At any time, it is necessary to prove that all requirements have been verified and checked: cleanliness (number of particles / given volume), temperature, hygrometry, pressure values must be within the specs with respect to the given manufacturing process rules. Through a secure connection to any Web browser, IVTracer user interface has been crafted to answer all monitoring prerequisites for the pharmaceutical environment, in an intuitive and user-friendly way. “IVTracer perfectly answers our Manufacturing Good Practices and GMP” underlines Louise Marlier, Quality Responsible at ACCINOV.“Because IVTracer is an easy-to-qualify solution when the most critical aspects of an environmental monitoring system are at stake”, she added.
Architectured and developed by NetCeler’s engineers, IVTracer software functionalities allow to: |
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• Guarantee full traceability, from the data acquisition system connected to sensors till the database, where information is stored.
• Optimize the control of the manufacturing environment through online and automatic measurements.
• Track all data in real-time.
• Manage personalized alarm triggers: alarms, pre-alarms,, occurrence and disappearance delays, hysteresis, high and low thresholds, etc.…
• Ease the expansion and full deployment of the system |
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