Bio-pharmaceutical

/Bio-pharmaceutical

February 2022

Long-term storage of trial master data. Physical or Electronic?

By | February 14th, 2022|Bio-pharmaceutical, News|

Recent changes to the European Medicines Agency’s (EMA) guidance requires that Trial Master File (TMF) data is kept in an accessible and readable format for a minimum period of 25 years.  As such, all pharmaceutical companies have a regulatory requirement for the long-term storage of data. Whilst there remains the argument that paper records storage [...]

October 2016

What Causes Paper to Deteriorate in Storage?

By | October 3rd, 2016|Bio-pharmaceutical, News|

Paper frequently deteriorates in storage, however this is not necessarily an inevitable process and can be protected against.  Below are the five key causes: (1)  Biological growths Biological growths such as molds or fungi typically occur when both temperature and humidity are uncontrolled. Molds digest the material on which they grow, resulting in the staining and deterioration [...]

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