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Articles by Vaisala

The Care & Feeding of an Environmental Monitoring System: Getting to GxP Compliance & Staying There

Jul 31, 2013

Not only must your software-based monitoring solution be integrated into your organization?s Quality Management System; its compliance must also be maintained over time. This App Note explains how to ensure continued GxP compliance in your monitoring system for temperature-controlled environments.

USP Guidance Chapters for Temperature-Controlled Supply Chains

Dec 18, 2012

This paper looks at the five general chapters of the updated and revised United States Pharmacopeia and The National Formulary (USP 33?NF 28) that touch upon the temperature-sensitive supply chain.

FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains

Aug 28, 2012

This paper discusses a scientific approach to cold chain management, overview of ICH guidance, three key FDA regulations, and examples of cold chain 483 observations.

Monitoring Systems: Sorting out Wireless

Dec 27, 2011

Monitoring systems for temperature, humidity and other parameters can be complex, involving hundreds of sensors in a variety of applications. One of the most important decisions in selecting or adding to a monitoring system is choosing the connectivity method that will allow the sensors to speak to a central processing unit. Decisions on connectivity are dependent upon several factors, including: data integrity requirements for regulatory purposes, logistical concerns such as access points for transmitters, and existing network infrastructures. In this article, we describe the most common wireless methods of connecting sensors to a monitoring system and offer eight considerations for selecting a method best suited to the application.

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