Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

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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…

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New Records Management Training Programme Launched

We are pleased to announce the launch of a new introductory training programme for records management and archiving staff, in conjunction with Heath Barrowcliff Consulting Ltd. This is comprised of three 1-day modules spread across a year. At only £250 (plus … Continue reading

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The Multimedia TMF Becomes a Reality

The clinical records management community is currently enjoying an interesting debate regarding the need for interoperability standards for electronic trial master file (eTMF) content. The need for organizations to efficiently exchange documents and metadata between systems is becoming increasingly critical, … Continue reading

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How to Apply a Risk Based Approach to Records Management

The European Medicines Agency (EMA) has recently published its final reflection paper on risk based quality management in clinical trials, reference EMA/269011/2013, 18 November 2013.The management of trial records is barely mentioned in the paper but I took away a … Continue reading

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