Regulatory Expectations and SAP

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ricky07

#1
#1
Many Pharma companies now use SAP to manage their Quality data. Are these companies using SAP for Quality Incident management (Non-conformance and CAPA)? and if so, what do they extract for effective trend analysis as expectation from the Regulator?
 
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Ajit Basrur

Ajit Basrur

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#2
#2
It depends if the SAP functionality provided meets your organization requirements. However, have seen many cases where other software is used for quality incidents, that is integrated and "talks" to SAP.
 
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v9991

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#3
#3
ricky07 said:
Are these companies using SAP for Quality Incident management (Non-conformance and CAPA)?
Click to expand...
'requirements' is broad yet comprehensive word for adopting the SAP-QM module and its functionalities.; it extends from the specific_'content' - role - workflow - categories&categorizations - integration with the other modules etc.,

ricky07 said:
if so, what do they extract for effective trend analysis as expectation from the Regulator?
Click to expand...
Standard trend analysis include, trends of open/pending tasks per material-customer-vendor-notification-type

this can be supplemented with the custom-reports which can be generated, relevant and specific to your needs. (viz., specific codification groups etc)
 
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