Category: Blog
14 Oct, 2021
What is the Exchange Mechanism Standard (EMS)?
As a follow-up to last week’s blog instalment about the TMF reference model, we will now discuss the exchange mechanism standard (EMS). The EMS was developed by…
05 Oct, 2021
What is the TMF Reference Model?
The Trial Master File Reference Model (TMF reference model) was created over 10 years ago with support from the Drug Information Association (DIA) Document and Records Management…
24 Sep, 2021
Regulation EU 536/2014: A Records Manager and Archivist’s Perspective
In April 2021, the European Medicines Agency Management Board confirmed that the Clinical Trial EU Portal and Database (a key component of the Clinical Trial Information System…
22 Sep, 2021
There’s a maturity model called the ‘three-legged stool’?
Following on from our previous post regarding maturity models, I’d now like to bring the three-legged stool model into the archiving picture. This model looks at three…
22 Sep, 2021
What are maturity models, and should I be using one?
In a nutshell, a maturity model is a tool designed to assess the effectiveness of your current digital archiving approach and/or processes. They’re useful in understanding your…
06 Sep, 2021
Four crucial reasons why Dropbox isn’t an appropriate archive for pharma documentation
As a digital preservation provider, we are often asked about alternate tools to safeguard pharmaceutical documentation. One in particular we’re regularly asked about is Dropbox. Today I…
