Information Governance Services for Organizing, Protecting and Repurposing Information and Data
Pharmaceutical and Biotech Company Specialist

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Dr. Charlie Sodano

Dr. Charlie Sodano

Pharma / Biotech
Information Manager Subject Matter Expert

Regulatory Compliance

FDAThe FDA and other regulating agencies require that certain records be kept for fixed amounts of time and may be called for during an audit or inspection.  This information is clearly stated in their guidelines.  However, like most things in life there is a gray area that is subject to interpretation.  The development of a drug may be paused for many years because of financial or other reasons and some older information may be subsequently used to support a future application to market the drug.

There is a tendency for people working in this area to retain all information permanently.  This ultimately leads to large collections that are tedious and expensive to manage.  A better approach is to follow the regulatory agencies retention policies and assess whether to retain the documents for a longer period of time. This is good because, one becomes more aware of what the collection consists of and can more easily manage the smaller piles instead of dealing with the whole.

At the end of a retention time, records are not summarily trashed.  They are examined for further disposition which may of may not include destruction.

The retention of so called raw data is another millstone.  To a scientist, and to the FDA, it is senseless to retain paper or electronic analytical results for long periods of time.  Better to rerun the analyses using better instruments and methodology than to refer to data that becomes increasingly difficult to find and maintain.