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About rammellel

Records management consultant to the life sciences / pharmaceutical industry

TMF Reference Model Gains Momentum

Posted on May 9, 2012

The Trial Master File Reference Model (TMF RM), a supported initiative through the Document and Records Management SIAC of the Drug Information Association (DIA) is a standard reference for the contents of a Trial Master File. First published in 2010, … Continue reading →

Posted in Regulations, TMF | Leave a comment

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

Posted on May 1, 2012

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

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

GCP Records Management – How Are We Doing in Canada?

Posted on April 20, 2012

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 →

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

Do You Destroy Records Securely?

Posted on April 1, 2012

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

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 Facebook a Validated System?

Posted on February 27, 2012

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 →

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

Ensure Your Informed Consent Forms Comply With New Requirements

Posted on February 10, 2012

For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to … Continue reading →

Posted in Compliance, Regulations | Leave a comment

GMP Directive (2003/94/EC) to cover active substances?

Posted on January 24, 2012

The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of … Continue reading →

Posted in Compliance, GMP, Regulations | Leave a comment

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

Posted on January 23, 2012

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