Articles

Affichage des articles du mai, 2014

Encore des écarts sur l'"intégrité des données"...

Cet établissement pharmaceutique indien s'est vu notifié plusieurs écarts relatifs à l'intégrité des données de son site de production de principes actifs:
1.    Failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.

For example,

a.    Your firm is missing the fundamental raw data and information necessary to document your analyses. For example, these analyses lack the following critical data:
identification of the samples tested, including name and source, batch number or other distinctive code, and date of the samplethe complete record of all raw data generated during each test, including graphs and electronic files from laboratory instrumentationtest method usedsample preparation as prescribed by the method, preparation and testing of standards, reagents and standard solutionsrecords of all calculations performed in connection with the testtest resultsthe signature of…