An early 2021 inspection of an Eli Lilly pharmaceutical plant in Indianapolis led to the FDA issuing a Form 483. The inspectional observations that were listed in the form included problems with environmental monitoring, microbial contamination prevention procedures, and root cause investigations...Read More
What Belongs On The First Page?
Whether you have brought on an organization to map your facility, or you are performing the mapping study yourself, you will need to know what the document containing mapping or validation results looks like. While it may seem cliché, the first page of your mapping...Read More
What Do You Do With All That Data?
After the mapping study is complete, when you’ve collected all of your labeled EDLM’s from your temperature mapping locations, and have them in a container with pages of their associated data sheets at your desk, it’s time to start the next step of the temperature...Read More
Some abbreviations and acronyms are like words in our vocabulary: we don’t even think twice when we see them. In the digital world, acronyms like LOL, and NP, are part of our colloquial language. Even in the business world, acronyms like PO are nearly universal to companies, and make up the fabric...Read More
Industry terms can have different meanings to the different people inhabiting the industry. When we hear the term "Concrete Curing" we immediately think of temperature and evaporation. The construction worker on site doing the curing however, he may think of the strength and durability of the...Read More
Pharmaceuticals are some of the most closely monitored goods in the world, and their storage conditions are no exception. Until recently however, when a company was monitoring the temperature of a pharmaceutical drug, they were probably only interested in those drugs that inhabited the cold chain....Read More
Over the last two months, we posed the question: ”Is figuring out the temperature of your warehouse like trying to understand alchemy?” because that’s something that we ask ourselves here at Dickson all too often. These questions inevitably lead to more questions about warehouse mapping, and...Read More