Category Archives: e-records

How Much Do YOU Know About eTMFs?

We have been maintaining Trial Master Files for many years with increasing levels of consistency and quality since the introduction of Good Clinical Practice guidelines in the 1990’s and more latterly, the publication of European Directives and Regulations that make … Continue reading

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Are You Struggling with Electronic Records?

In many ways, the management of electronic records is no different from the management of paper records. But – and it is a big ‘but’ – there are a few significant differences and one of these is the approach that … Continue reading

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The eTMF Solutions Basket Gets Bigger

Just a quick note to mention that a few more vendors providing solutions for electronic trial master files (eTMFs) have been added to our growing list. In addition to this list of packages solutions, there is also a large selection … Continue reading

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Digital Preservation – An Industry Initiative to Develop Standards

The challenge of ensuring the long-term accessibility, reliability and authenticity of archived electronic records has been with us for some time, particularly in an industry where retention times can be in excess of 15 years…. sometimes for the marketed life … Continue reading

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Will ePub or HTML5 Be The New Standard for Electronic Records?

As an industry, I think records managers and archivists have generally welcomed the emergence of PDF and PDF/A as a standard for the creation and preservation of documents. At last we have a format that enables us to view documents … Continue reading

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GCP Records Management – How Are We Doing in Canada?

Health Canada has recently released a publication summarising the results of GCP inspections carried out between April 2004 and March 2011. It makes for interesting reading compared to a similar document released by the MHRA three years ago. At 24.5% … Continue reading

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Use of Digital Signatures

I’ve just come across a White Paper from AIIM on the use of digital signature technology. As this makes for interesting reading, I thought I’d just share some highlights and provide a link to the full report: In 63% of … Continue reading

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