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1. ` SAP DEVELOPMENT (QMS + RA MODULE + MASTER DATA MANAGEMENT)

2. SAP QMS Modules:- Document Management System :- DMS configuration for all QMS documents attachment provision in SAP to replace the paper based system with digital documentation. Change Control Management :- To record the changes with version in Process, System, Equipment & any Documents like as SOP/Specifications etc. we use CCF module for initiation, HOD approval & QA /Other dept. comments. Deviation Management :- Used to capture any Process/System deviation in SAP with assessment report and linkage with CAPA documents if required. we use Deviation module for initiation, HOD approval, Risk assessment & QA comments. Incidence Management :- Used to capture any Process/System Incidence in SAP with HOD approval Risk assessment & QA comments.

3. SAP QMS Modules:- CAPA Management:- With reference of deviation CAPA documents generated and we use this module for initiation, HOD approval, Risk assessment & QA comments. SOP Management:- All the SOPs need to created in draft mode in system with approval ,Finalization, Revision & Distribution with authorization control. Column Management:- We can track the HPLC columns management in this module with reports. Manufacturer Approval and Evaluation Module:- In this Module we are maintaining RM /PM Manufacturer approval with necessary documentations and tracking with their expiry dates. Based on vendor’s batch performances we can do evaluation process.

4. SAP QMS Modules:- OOS – Out Of Specification:- Batch wise OOS recording with parameter & Validation in system. OOT – Out Of Trend:- Batch wise OOS recording with parameter & Validation in system. Specification & STP Module: - Material type wise specification and linking with STP.

5. SAP Regulatory Modules:- Document Management System. Product Permission Form. Dossier Requisition & Approval. Dossier Status Tracking Report. COPP & FSC Modules. CTD Structure Management & Report. Advance Mail Alert for Dossier Renewal and Expiry.

6. SAP Master Data Management:- Material Code Creation Request and Approval Process:- Request , Approval , Verification & Master data Creation in System. Mail Alert on each stage for information to all related team members. Vendor Code Creation Request and Approval Process:- Request , Approval , Verification & Master data Creation in System. Mail Alert on each stage for information to all related team members. Customer Code Creation Request and Approval Process:- Request , Approval , Verification & Master data Creation in System. Mail Alert on each stage for information to all related team members.

7. Delivering Business innovation to:-

8. Any questions? You can find me at: Glad to assist you with our solutions to improve ROI and TOO on your SAP Investment You can reach me at [phone] or [email protected]