Category Archives: e-records

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

Posted on May 1, 2012 by

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?

Posted on April 20, 2012 by

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

Posted on March 7, 2012 by

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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Is Facebook a Validated System?

Posted on February 27, 2012 by

Well, of course the answer to the question posed in the title is a clear “No”…. at least as far as the pharmaceutical and biopharmaceutical industry understands and interprets validation. So why the question? My eye was drawn to an … Continue reading →

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Is it OK to “manipulate” PDFs to improve records management?

Posted on January 23, 2012 by

This is a question that I hear posed fairly frequently, I guess as a result of organisations managing electronic records rather than – or in addition to – traditional paper records. A typical scenario is an electronic document received into the … Continue reading →

Posted in Compliance, e-records, Litigation, Records management practice, Regulations | 1 Comment

Are Copies as Acceptable as Original Documents?

Posted on November 25, 2011 by

This is a question that I seem to be hearing with increasing frequency! I think the reason for this is that an increasing number of companies and organizations are introducing electronic document management systems (EDMS). Where there are hard-copy records … Continue reading →

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

eTMF Vendors – Who Has the Largest Market Share?

Posted on November 20, 2011 by

This is a question just sent through to us….. which vendor has the largest market share of the eTMF solution vendors? I guess the answer will depend on whether we’re talking about most client licenses/seats or highest volume of sales and whether … Continue reading →

Posted in e-records, TMF | 2 Comments

eTMFs from your Contract Research Organization (CRO)

Posted on July 19, 2011 by

I was recently asked what happens at the end of a clinical project when the CRO managing the study wants to hand over an electronic trial master file (eTMF). The sponsor may not have an existing eTMF to take the … Continue reading →

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PDF/A Standard Now Uses PDF v1.7

Posted on July 6, 2011 by

The International Organisation for Standardisation has just released the second part of its standard for long-term digital preservation of documents, ISO 19005-2:2011. The first part of the standard (ISO 19005-1) was issued in 2005 and describes the file format PDF/A … Continue reading →

Posted in Document Storage, e-records, Technology | 2 Comments

Are You Drowning in Email?

Posted on June 30, 2011 by

Whenever I chat with business colleagues, one of the most common issues that gets raised is that of email management: we’re receiving too much and spend too much time responding. Well, I just came across an “Email Charter” and thought … Continue reading →

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