Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

Update: MHRA GCP Guide Now Available in Electronic Format

Further to my posting in September to alert you to the availability of a new guide to Good Clinical Practice (GCP) from the MHRA, this guide is now also available electronically in Kindle format. Please note: it appears that currently … Continue reading

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MHRA Publishes TMF FAQs

The UK MHRA have published a set of Frequently Asked Questions on the topic of Trial Master Files and Archiving. These can be found on the their online forum. Readers who have purchased a copy of the recently published MHRA … Continue reading

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TMF, eTMF, eTMF System…. What is the Difference?

One of the questions that I get asked repeatedly is what exactly is the trial master file (TMF). I represented this graphically a number of years ago, as follows: For quite a while, industry thought that the TMF was just … Continue reading

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Do You Have a Secure Chain of Custody?

The recent news O2/IBM has misplaced a data tape containing unencrypted personal data just emphasises to me the need to have a secure chain of custody for our data and records. This means ensuring that when records are passed from … Continue reading

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