Category Archives: Compliance

Do You Have Records Management Problems?

Posted on July 20, 2018 by rammellel

If you look through my blog posts and LinkedIn updates over recent years, you’ll be forgiven for thinking that all I do is support pharmaceutical companies with their trial master files (TMFs). It is true that this has taken up … Continue reading →

Posted in Compliance, Data protection, Records management practice | Leave a comment

MHRA Draft Guidance on GxP Data Integrity….. a Few Thoughts

Posted on December 14, 2016 by rammellel

In July 2016 the Medicines and Healthcare products Regulatory Agency (MHRA) released a definitions and guidance document on the topic of data integrity for GxP regulatory data. The public consultation period closed on 31 October 2016. However, I’ve been hearing … Continue reading →

Posted in Compliance, e-records, Technology | Leave a comment

Is the Clinical Database part of the Trial Master File (TMF)?

Posted on July 27, 2015 by rammellel

This was a question posed recently on the MHRA GCP Forum (see http://forums.mhra.gov.uk/showthread.php?1858-Database-and-TMF).  I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” … Continue reading →

Posted in Compliance, e-records, Technology, TMF | 2 Comments

EMA Cancels Revision of Reflection Paper on Trial Master Files

Posted on June 17, 2015 by rammellel

On 1st February 2013 the European Medicines Agency (EMA) released for public consultation a draft reflection paper on GCP compliance, including management of trial master files. After a three month consultation period which ended on 30th April 2013, industry has … Continue reading →

Posted in Compliance, Regulations, TMF | Leave a comment

The World Slowly Wakes to the Reality of TMF Requirements

Posted on April 25, 2014 by rammellel

Perhaps my title is somewhat harsh but I perceive more than a little frustration in the announcement today from the MHRA that they are revising their definition of critical inspection findings to include cases “where provision of the Trial Master … Continue reading →

Posted in Compliance, Records management practice, Regulations, TMF | Tagged , , , | 2 Comments