Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

EMA Cancels Revision of Reflection Paper on Trial Master Files

On 1st February 2013 the European Medicines Agency (EMA) released for public consultation a draft reflection paper on GCP compliance, including management of trial master files. After a three month consultation period which ended on 30th April 2013, industry has … Continue reading

Posted in Compliance, Regulations, TMF | Leave a comment

Thoughts from the DIA EU Electronic Document Management Conference

[Also posted on LinkedIn Pulse] I have just attended the 15th Drug Information Association (DIA) European Electronic Document Management conference in Berlin. Here are a few thoughts and observations that came to mind as I sat through some of the … Continue reading

Posted in Uncategorized | Tagged , , , , | Leave a comment

How to Implement a Successful eTMF Project

If you are considering implementing an eTMF or perhaps you are already in the middle of such a project, there is still time to register on our 1-day eTMF workshop being held on Monday 1st December in Berlin, Germany. Technology solutions … Continue reading

Posted in e-records, TMF, Training | Leave a comment

TMF Benchmarking

A quick blog post today! Have you completed our TMF Benchmarking Survey? We are running a very brief online survey to identify any trends in terms of how companies are defining their TMF and how they interact with CROs with … Continue reading

Posted in Records management practice, Technology, TMF | Tagged | Leave a comment

The World Slowly Wakes to the Reality of TMF Requirements

Perhaps my title is somewhat harsh but I perceive more than a little frustration in the announcement today from the MHRA that they are revising their definition of critical inspection findings to include cases “where provision of the Trial Master … Continue reading

Posted in Compliance, Records management practice, Regulations, TMF | Tagged , , , | 2 Comments

Training for Records Managers & Archivists

It is not often that I use my blog to promote meetings, conferences etc but I’m going to make an exception today! For those records management professionals working in the life sciences, there are few events that provide training specific … Continue reading

Posted in Records management practice, Training | Tagged , | 1 Comment

Fire Destroys Argentine Banking System Archives, Killing 9

Originally posted on mediachecker:
February 6, 2014 While we are sure it is a very sad coincidence, on the day when Argentina decrees limits on the FX positions banks can hold and the Argentine Central Bank’s reserves accounting is questioned…

Posted in Uncategorized | Leave a comment