general

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....

1. Patient Monitoring

Remote patient monitoring seems a little creepy, and a little far-fetched. To treat symptoms, doctors and nurses have to actually see the symptoms, right? For now, right. But once a patient has been diagnosed, remote monitoring can kick in. Especially if a patient is out of...

21CFR11 is to Food and Pharmaceutical professionals what Dr. Kelso was to Sacred Heart Hospital in the television series Scrubs. Annoying, but necessary.

In September 2018 WHO announced a new effort – the WHO Global Initiative for Childhood Cancer – with the aim of reaching at least a 60% survival rate for children with cancer by 2030, thereby saving an additional one million lives. This new target represents a doubling of the global cure rate for...

As part of the U.S. Food and Drug Administration’s efforts to promote drug competition and patient access, we’ve advanced many policies aimed at making it more efficient to bring generic competition to the market. We have been especially focused on a category of medicines known as complex drugs....

“You need to worry about data integrity from all levels of the supply chain. Once there are data integrity lapses, you know there are other things you don’t know.”

While we won’t make the direct connection that the most successful pharmaceutical companies can attribute their success directly from strictly adhering to regulations, in our experience, the big guns in the industry know auditors, regulations, and compliance like the back of their hand. But what do...

We are currently moving into the depths of summer, nearing the end of sun burned grass, and towards the oranges, reds, and yellows of fall. Summer brings hot weather, whether humid or dry. For one particular group of our customers, that means a change in how the produce, implant, and monitor their...

In the past few months, we've published two posts on temperature and humidity monitoring in an archive or museum. The first article was a general introduction to artifact storage. In the second article, we offered up some key questions you should ask when crafting your monitoring plan . . .