Regulatory Expectations and SAP

R

ricky07

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?
 
Ajit Basrur

Ajit Basrur

Leader
Admin
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.
 
V

v9991

Trusted Information Resource
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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