Welcome back to the second discussion and example document generation of a User Requirement Specification! I had promised to go over an example system and help craft a draft URS but first there needs to be a standard for documenting what types of systems need which documentation.  

Welcome back temperature sleuths and life science experts to a new week and a new thrilling topic! This week I am going in depth into a crucial piece of quality compliance and validation documentation called a User Requirement Specification or URS for short. Now why is this topic so important in today's pharmaceutical and life science industries?   Read More

Now that we have approached the final post of our series about temperature, let’s go through how temperature is connected within your facility. The image below depicts the equipment and temperature requirements that when combined with robust and durable data loggers and FDA complaint 21 CFR Part 11 software can help you achieve quality products for your customers and patients. But first, in order to achieve quality products, temperature must be validated and continuously monitored and recorded consistently with regulatory...

Do you want a pizza, fifty frozen burgers, how about some test standards?  I knew you would go for the test standards!  Once again, we are back discussing temperature within the life science industry, and this time we are chatting about -20°C and -40°C freezer temperatures...   Read More

When we think of 2-8°C, we automatically think of our household refrigerators which keep our groceries fresh and our beer cold. However, in the life sciences industry, fridges keep the ideal, stable temperature for everything from integral and important testing standards to products and raw materials. In order to keep these integral products, raw materials and test standards safely stored, companies need to

In the life sciences industry, 25°C is considered one of the most important temperatures as it is an ambient or immediate surrounding temperature condition.  All life science facilities develop, manufacture, research, or store raw materials and finished product under ambient conditions.  The 25°C temperature condition needs to be mapped, validated, monitored, and controlled by many different integral systems.

This is post 1 of an 8-part series that we are calling “What can Temperature Do for You?” In this 8-part series, we will be looking at the various areas and applications where temperature is the guiding factor to a successful product or process. Every week we will focus in on certain temperatures and discuss life science industry applications with equipment and software solutions to help you understand each temperature requirement within your facility. Stay tuned!   Read More