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 MoreHealthcare IT is at the forefront of medical development these days. In previous editions of Dickson Insights and on our blog, we’ve outlined top twitter accounts, best websites and links, and other resources meant to help out those in the Healthcare IT landscape that is constantly changing around...
Read MoreAfter 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 MoreWhen it comes to regulatory bodies and concrete descriptions of how exactly you should be monitoring your environment . . . well it never comes to that.
Read More1. YOUR TRANSPORT ROUTE IS BEING SCRUTINIZED
Read MoreFor actual Medical Device Manufacturers, the question posed in the title of this article may seem a little silly. Medical Device Manufacturers obviously know who monitors, regulates, and audits them, and who they have to answer to when something goes wrong. For the rest of us though? We are left...
Read MoreLast month in Dickson Insights, our feature story focused on server room and data center temperature. We outlined an issue that happened at Yale University, and talked through the different temperature and humidity nuances that a data center provides. What we did not touch on, were the benefits of...
Read MoreIf you’re in the quality assurance business like us, validation is a term you hear every day. "Validation" falls under the umbrella of terms businesses use to discuss the quality of their product, facility, or service. (Similar terms: IQ/ OQ/PQ, SOP’s, Storage, Deviation, Key Operating Procedure,...
Read MoreIndustry 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 only think of strength and durability.
Read MoreThe ISPE describes itself on its website: www.ispe.org, as ”the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.”
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