samedi 15 novembre 2014

Une nouvelle mise en demeure pointe des défaillances dans la gestion des données électroniques de laboratoire...

L'agence américaine a cité cet écart dans une "Warning Letter" publiée le 15 octobre 2014 :

3.    Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.

Your firm did not have proper controls in place to prevent the unauthorized manipulation of your electronic raw data. For example,

a.    The inspection found that
the audit trail feature for your gas chromatography (GC) instruments was not used until October 2013, even though your 2009 GC software validation included a satisfactory evaluation of the audit trail capability.
b.    There is no assurance that you maintain complete electronic raw data for the (b)(4) GC instruments, the Malvern particle size analyzer, and the ultraviolet (UV) spectrophotometer. Our inspection found that these instruments were connected to stand-alone computers that stored the data and that the data could be deleted   
c.    Prior to our inspection, your firm failed to have a back-up system for the data generated by one of the(b)(4) Fourier transform infrared spectrometers, the polarimeter, the UV spectrophotometer and the Malvern particle size analyzer.
Your response states that data from these, as well as other laboratory instruments is now saved on a central server and that a new LIMS system will be installed in October 2014.  Your response provided an interim solution for electronic raw data retention. Provide any additional steps that you are taking to assure integrity of your electronic raw data.  

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