Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

When Is a Photocopy Not a Photocopy?

It appears that the answer may be when you use a Xerox scanner to produce the copy! According to a story reported today, the “normal” scan settings on at least two models of Xerox scanner actually change the characters that … Continue reading

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Where Are We With ‘Digital By Default’?

The UK eGovernment Interoperability Framework (eGIF) was established over 10 years ago to include a range of different initiatives to make Government more efficient by introducing standardisation. Part of this strategy included the goal of moving towards the digitisation of … Continue reading

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When is a CSR a TMF?

It appears that the anxiety within the industry regarding the proposed Trial Master File retention requirements in the draft EU Clinical Trial Regulation may be unfounded. Earlier today I had the pleasure of meeting Mrs. Marina Yannakoudakis MEP at her … Continue reading

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Where Next for the Digital Age?

I found the BBC News story today regarding digitisation of the UK Courts system very interesting. The Government has plans to make courtrooms in England and Wales “fully digital” by the year 2016, ending what it described as “an outdated … Continue reading

Posted in e-records, Litigation, Records management practice, Technology | 2 Comments

Clinical Trials EU Regulation – Even More Bizarre

Following the recent vote of the ENVI Committee on the several hundred amendments put forward to the proposed EU Clinical Trial Regulation, the consolidated report containing all carried amendments has now been published. Report A7-0208/2013 entitled “Report on the proposal for a … Continue reading

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Clinical Trials EU Regulation – An Update

You will remember that I wrote a few weeks ago about the proposed Clinical Trial Regulation which will replace EU Directive 2001/20/EC. Specifically, myself and many of my industry records management colleagues were extremely concerned about Amendment 60 which was … Continue reading

Posted in e-records, Regulations, TMF | 1 Comment

An eTMF is For Life, Not Just For Christmas! Achieving Archive Compliance

This is the title of the next webinar that we are involved with. This topical webinar will be structured as follows: Karen Redding of Phlexglobal will present the current eTMF industry status and how eArchiving is not being addressed;     Eldin … Continue reading

Posted in e-records, Technology, TMF, Training