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制药厂商数据管理的整体方法

2018年09月25日 09:22:38来源:美国粒子监测系统公司点击:10762


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  【中国化工仪器网 名企动态】PharmaIntegrity makes it quick and easy to identify and trend cleanroom contamination problems before they occur.
 
  September 25th, 2018, Boulder, CO – Particle Measuring Systems (PMS) and Novatek International have partnered to create the first fully integrated cleanroom data management system, to securely meet regulatory requirements and ensure product integrity. This combination allows pharmaceutical manufactures to quickly and easily set up a fully integrated cleanroom monitoring and data management system.
 
  “By combing the long-term reliability of PMS contamination monitors and our data management and trending system, we can offer our customers a trustworthy plug n play solution that is very adaptable for long-term growth”, said Sarah Alimirzaei, Director of Strategic Alliances for Novatek International.
 
  All critical data is secured in a single system that connects global sites worldwide, making data readily accessible to the Quality Assurance department. This makes product releases easy, quick and compliant with industry regulations including 21 CFR Part 11, ISO 14644-1/2, and EU GMP Annex 1.
 
  “Particle Measuring Systems uniquely offers our customers a complete solution package, with advisory services, particle and microbial monitors, cleanroom monitoring systems, training and education, and now, through our partnership with Novatek, data management”, said Giovanni Scialo, VP of Life Sciences, Particle Measuring Systems.
 
  About Particle Measuring Systems
  


 
  Particle Measuring Systems Inc. (PMS), a subsidiary of Spectris plc, is a global technology leader in contamination monitoring, the inventor of laser particle counting, and is now the leading provider of complete solutions for monitoring and controlling many forms of contamination that impact companies that manufacture in ultra-clean environments. 
 
  About Novatek International
 

  Established in 1996, Novatek’s mission is dedicated to help pharmaceutical companies and other life science organizations leverage their investment in information technology and quality processes by reducing cost, improving productivity and enhancing compliance. With 20 years of user experience and developer level technical support, simple or complex installations are seamless and rapid. The architecture of all Novatek solutions are out of the box, modular and process-based, enabling the applications to be delivered “business-ready” providing the building blocks for a complete quality solution.
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