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Day in the Life Scenario

Day in the Life Scenario. Day in the Life: Scenarios. Demonstrate the end-to-end Quality Inspection for the following scenarios Quality Inspection for incoming raw material against Purchase Order Quality Inspection for final product against Process Order Re-inspection for raw material.

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Day in the Life Scenario

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  1. Day in the Life Scenario

  2. Day in the Life: Scenarios • Demonstrate the end-to-end Quality Inspection for the following scenarios • Quality Inspection for incoming raw material against Purchase Order • Quality Inspection for final product against Process Order • Re-inspection for raw material

  3. Day in the Life: Quality Inspection for Final Product • This scenario demonstrates the Quality Inspection Process for Final Product – Pseudozone ; Dosage Strength 10mg • The Inspection Lot is triggered by SAP based on the GR for Process Order. The Lot is interfaced to VelQuest, which will complete the Lab testing and results are sent back to SAP. The final approval is completed in SAP by posting the Usage Decision and Stock disposition SAP VelQuest SAP

  4. Day in the Life: Process Order in SAP Figure: Create and Release Process Order for Pseudozone product in SAP

  5. Day in the Life: Goods Receipt in SAP Figure: Post Goods Receipt (GR) against process order for Pseudozone in SAP

  6. Day in the Life: Material Document in SAP Figure: Material Document generated on posting GR in SAP

  7. Day in the Life: Inspection Lot in SAP Figure: Verify Inspection Lot Generated from Goods Receipt in SAP

  8. Day in the Life: Quality Inspection Stock in SAP Figure: Verify stock is posted to Quality Inspection Stock for Pseudozone in SAP

  9. Day in the Life: Interface from SAP to SmartLab Figure: Inspection Lot entry updated in the QM-IDI Table for SAP – SmartLab Interface

  10. Day in the Life: Sample Inspection in SmartLab Figure: Supervisor log into SmartLab

  11. Day in the Life: Pending Work in SmartLab Figure: In SmartLab, Supervisor reviews pending sessions from SAP

  12. Day in the Life: Work Assignment in SmartLab Figure: Assign work to resource using SmartLab

  13. Day in the Life: Work Release in SmartLab Figure: Release work to the lab

  14. Day in the Life: Sample Analysis in SmartLab Figure: Analyst log into SmartLab

  15. Day in the Life: Analyst Worklist in SmartLab Figure: Analyst identifies work ready for Lot 40000000075

  16. Day in the Life: Sample Analysis in SmartLab Figure: Analyst performs ‘Product Tablet Appearance’ Test in SmartLab

  17. Day in the Life: Sample Analysis in SmartLab Figure: Analyst performs result entry in SmartLab

  18. Day in the Life: Sample Analysis in SmartLab Figure: Analyst performs Product Dissolution test in SmartLab

  19. Day in the Life: Sample Analysis in SmartLab Figure: Analyst perform product assay / degradation test in SmartLab

  20. Day in the Life: Sample Analysis in SmartLab Figure: Analyst notes number of unidentified peaks

  21. Day in the Life: Result Recording in SmartLab Figure: Analyst records data for unidentified peaks in SmartLab

  22. Day in the Life: Result Recording in SmartLab Figure: Analyst notes supporting data reference for HPLC in SmartLab

  23. Day in the Life: CDS Integration in SmartLab Figure: Analyst captures HPLC run output as supporting data in SmartLab

  24. Day in the Life: Result Recording in SmartLab Figure: Analyst captures Final Results in SmartLab

  25. Day in the Life: Result Review in SmartLab Figure: Reviewer logs into SmartLab

  26. Day in the Life: Result Review in SmartLab Figure: Reviewer reviews and approved test results in SmartLab and submits to SAP QM

  27. Day in the Life: Inspection Results in SAP Figure: Inspection Results are verified in SAP after receipt from SmartLab

  28. Day in the Life: Batch Review & Release in SAP Figure: Usage Decision performed for Inspection Lot in SAP

  29. Day in the Life: Batch Review & Release in SAP Figure: Usage Stock Posting for Inspection Lot in SAP

  30. Day in the Life: Batch Review & Release in SAP Figure: Digital signature (E-Signature) recorded for performing Usage Decision in SAP

  31. Day in the Life: Stock Overview in SAP Figure: Verify Stock is posted from QI to Un-Restricted Stock in SAP

  32. Day in the Life: Quality Inspection for Raw Material (Incoming Goods Receipt) • This scenario demonstrates the Quality Inspection Process for Raw Material – Pseudozone Raw • The Inspection Lot is triggered by SAP based on the GR for Purchase Order. The Lot is interfaced to VelQuest, which will complete the Lab testing and results are sent back to SAP. The final approval is completed in SAP by posting the Usage Decision and Stock disposition SAP VelQuest SAP

  33. Day in the Life: QM Master Data in SAP Figure: QM Master Data Set-up for Raw Material - Material Master

  34. Day in the Life: QM Master Data in SAP Figure: QM Master Data Set-up for Raw Material - Inspection Characteristics

  35. Day in the Life: QM Master Data in SAP Figure: QM Master Data Set-up for Raw Material Inspection Plan

  36. Day in the Life: Goods Receipt in SAP Figure: Post Goods Receipt (GR) against purchase order for Pseudozone Raw in SAP

  37. Day in the Life: Inspection Lot Worklist in SAP Figure: Inspection Lot Worklist - Generated on posting GR in SAP

  38. Day in the Life: Inspection Lot in SAP Figure: Verify Inspection Lot Generated and Specification has been assigned

  39. Day in the Life: Quality Inspection Stock in SAP Figure: Verify stock is posted to Quality Inspection Stock for Pseudozone Raw in SAP

  40. Day in the Life: Interface from SAP to SmartLab Figure: Inspection Lot entry updated in the QM-IDI Table for SAP – SmartLab Interface

  41. Day in the Life: Interface from SAP to SmartLab Figure: Inspection Lot entry updated in the QM-IDI Table for SAP – SmartLab Interface

  42. Day in the Life: Sample Analysis in SmartLab Figure: Analyst log into SmartLab

  43. Day in the Life: Analyst Worklist in SmartLab Figure: Analyst identifies work ready for Lot 10000000456

  44. Day in the Life: Sample Analysis in SmartLab Figure: Analyst perform product assay / degradation test in SmartLab

  45. Day in the Life: Result Recording in SmartLab Figure: Analyst notes supporting data reference for HPLC in SmartLab

  46. Day in the Life: CDS Integration in SmartLab Figure: Analyst captures HPLC run output as supporting data in SmartLab

  47. Day in the Life: Result Recording in SmartLab Figure: Analyst captures Final Results in SmartLab

  48. Day in the Life: Result Review in SmartLab Figure: Reviewer logs into SmartLab

  49. Day in the Life: Result Review in SmartLab Figure: Reviewer reviews and approved test results in SmartLab and submits to SAP QM

  50. Day in the Life: Inspection Results in SAP Figure: Inspection Results are verified in SAP after receipt from SmartLab

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