A simple rule.....if it isn't written down...it didn't happen.
Therefore if something, anything, goes wrong as in your example and
you do not fill in a deviation report then you may well find yourself
in trouble during auditing for "hiding" information.
However, have a look at the way you handle these reports. A deviation
report..if handled intelligently can in some cases take less than 5
minutes to perform and prepare.
Malcolm Ross
Generapharm-Training and Consultancy
Basel - CH
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