Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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has plans to make courtrooms in England and Wales “fully digital” by the year 2016, ending what it described as “an outdated … Continue reading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

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

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

Why are Signatures Missing from the Average Office Computer Desktop?

Have you ever thought about the decision-making process for the purchase of office desktop software? I’ve never been involved in this activity so it is something I admit to knowing almost nothing about! However, there is one aspect that has … Continue reading

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Migration Options for SharePoint 2013: Consider Your Options Carefully

This is the title of a blog posted recently on the AIIM website and I’d encourage you to take a look. The reason that I’m highlighting this link is because it is just so relevant given the presentation that I … Continue reading

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Should Legislation Mandate Specific Minimum Retention Periods for Documents?

If we consider a variety of legislation on the statute book in the UK for example, it is more often the case that citizens and corporations are left to define their own retention period that is consistent with both the … Continue reading

Posted in Records management practice, Regulations, TMF | 1 Comment