Regulatory Expectations and SAP

R

ricky07

#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

Staff member
Admin
#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.
 

v9991

Trusted Information Resource
#3
Are these companies using SAP for Quality Incident management (Non-conformance and CAPA)?
'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.,

if so, what do they extract for effective trend analysis as expectation from the Regulator?
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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