Blog Archives - Arkivum

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14 Oct, 2021

What is the Exchange Mechanism Standard (EMS)?

Whitney Armstrong

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?

Whitney Armstrong

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

Russell Joyce

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’?

Harriet Clark

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?

Harriet Clark

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

Chris Sigley

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…