GMP-compliant calibration for the life sciences industry
Guarantee GMP compliance and reduce auditing costs with ISO/IEC 17025-accredited calibration service
After the initial calibration in the factory, regular recalibration of measuring devices helps to maintain productivity, quality, and traceability. In the life sciences industry in particular, measuring devices must be calibrated in an external laboratory or directly on site by an accredited service provider to maintain GMP compliance. The calibration process is monitored in regular audits performed by the regulatory authorities in the relevant industry, e.g. FDA (Food and Drug Administration).
Benefits
Guaranteed GMP compliance with ISO/IEC 17025-accredited calibration for all parameters
Our non-proprietary on-site calibration service reduces your calibration costs while increasing measurement availability
Total audit security and GMP compliance thanks to specially GMP-trained calibration technicians and ISO/IEC 17025-compliant calibration certificates
Development and optimization of SOPs boosts the efficiency of your calibration processes
We generate cost savings by optimizing calibration planning based on KPI analyses and state-of-the-art verification procedures and technologies.
Quality, measurement accuracy, and reproducibility
In the heavily regulated life sciences industry, quality, measurement accuracy, and reproducibility are of crucial importance. For this reason, manufacturers must comply with the regular calibration requirements that apply in the sector, as set out by the FDA and GMP ("Good Manufacturing Practice"). What's more, any incremental improvement in measurement accuracy can equate to enormous cost savings – for example when dosing or filling pharmaceutical products worth millions of CHF per kilogram.
Traceable calibration – wherever you need it
Transparency and traceability are two key topics that are taking on an ever-increasing importance in the life sciences industry.
All of our calibration rigs are accredited by various national metrology authorities in accordance with ISO/IEC 17025, including DAkkS (Germany) and SAS (Switzerland). These accreditations also guarantee that all equipment used during calibration can be traced back fully, via an uninterrupted chain of calibrations, to the national reference standards.
GMP calibration tailored to your requirements
Depending on your requirements, we can perform calibration on site or in one of our accredited calibration laboratories. Endress+Hauser provides an expert calibration service so that you can concentrate on your core competence – the production of medicines. Our calibration technicians are specially trained in GMP; they possess extensive knowledge of measurement technologies and work on the basis of SOP specifications.
The fully traceable reference devices used for calibration ensure high-quality calibration results. Transparent and ISO/IEC 17025-compliant documentation guarantees full audit and GMP compliance. At Endress+Hauser, we ensure that our calibration technicians worldwide are trained in all processes and regulations. With over a million calibrations for all parameters (independently of manufacturers), both in our laboratory and on site, Endress+Hauser has years of proven experience in the field.
Planning, documenting and optimizing calibration processes
Our experts will help you to reduce the time you dedicate to calibrating your devices while also increasing the quality of your calibration. We support you throughout the process of defining Key Performance Indicators (KPIs) to evaluate processes, to drafting calibration specifications and implementing a complete calibration management solution.You alone decide on how and to what extent we can help you.
Further information
The benefits of our calibration service >>>
Downloads
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Einzigartige Kalibrierkompetenz (CP01102H)
Qualitätsstandards sichern und Kalibrierprozesse optimieren
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