Category Archives: Records management practice

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 →

Posted in e-records, Records management practice, Technology | Tagged , | Leave a comment

DIA EDM Corner Has Moved

Posted on April 23, 2012 by

This is just a quick notification that as a result of restructuring of the DIA (Drug Information Association) website, the link to the EDM Corner has now changed. The EDM Corner contains links to Trial Master File Reference Model and … Continue reading →

Posted in Records management practice, TMF | Leave a comment

Do You Destroy Records Securely?

Posted on April 1, 2012 by

When it comes to destroying records at the end of their retention period, I’m guessing that most records managers and archivists will have a well-established program to ensure such records are destroyed securely. There are industry standards for secure destruction, … Continue reading →

Posted in Document Storage, Records management practice, Technology | Leave a comment

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 →

Posted in e-records, Records management practice, Technology | Leave a comment

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

Documentation Risk Adaptations in Clinical Trials

Posted on October 30, 2011 by

A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of … Continue reading →

Posted in Compliance, Records management practice, Regulations, TMF | Leave a comment

Why Good Records Management Is Key

Posted on October 5, 2011 by

Authors: Eldin Rammell & Karen Redding (Phlexglobal Ltd) The past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be … Continue reading →

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

Questions a Sponsor Should Ask a CRO

Posted on July 27, 2011 by

While I was browsing through my website analytics, I came across the above question that was entered into a search engine which in turn directed somebody to the website. It got me thinking what a great question it was! So, from … Continue reading →

Posted in Compliance, Records management practice | Leave a comment

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 →

Posted in e-records, Records management practice | Leave a comment