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Lims Sap Integration PDF Free
Lims Sap Integration PDF Free
Sep 2012
A business function or business unit that interacts with all the business units in the manufacturing organization
Ensures the inbound, outbound and support materials are Business units
meeting the quality parameters Research & Clinical Trial Supply
Mfg.
Development (R&D) Site( CRO ) chain
QC Labs monitors and controls the quality parameters during
the process as well after the process
Business
Functions
Quality parameters are evaluated by performing the appropriate Warehouse
Purchase
The requests (regulatory requirement too) are submitted to QC Distribution Quality Production
Lab to perform tests with the representative sample of the control
material.
Identified based on the services provided – Microbiology lab, DMF TTP Ba/Be Pk/Pd
stability lab, wet chemistry lab, analytical lab, in process lab, (CMC) validationStudy Data analysis
R&D lab etc… Regulatory
Submissions
3 © 2012 IBM Corporation
Laboratory Process Flow
Huge Volume of Sample and data management – Identification, Tracking and Reporting
Difficult in identifying the deviation or variations from Standard Operating procedures (SOP) and correcting
the same
LIMS
Desire to Improve Productivity, efficiency of the Organization
3 Results Recording
4 Usage Decision
5 Reports
LIMS –
ELN ELN
CDMS
Material Specifications
SAP
DCS
MES
LT011
LT012
Following three RFCs can be used for Result recording for Characteristics:
downloading inspection lot to the – QIRF_GET_FEATURE_VALUES2
subsystem though the QM-IDI interface.
Usage Decision:
– QIRF_SEND_INSP_REQUIREMENTS
– QIRF_GET_USAGE_DECISION2
– QIRF_SEND_INSP_DATA_FOR_WL2
– QIRF_SEND_REQUIRMENTS_GET_D Once the usage decision has been send
AT2 back to SAP from the sub-system, the
– QIRF_SEND_REQUIRMENTS_GET_D inspection lot get closed and the
AT2 internally call the first two RFCs communication completed.
External LIMS system needs to call any of
the above RFCs to download the
inspection lot from SAP
Appendix