1. RLINK QM, SAP Integration PI Tools for Analysis Dr. Gretchen Schwenzer, OSI Software

2. Objectives of Integrating QM and SAP Provide Data Required by Enterprise to Validate Products Produced and Materials Purchased Capture and Store the Data to Improve, Control, Analyze, and Diagnosis the Process Support the Laboratory Functions and Laboratory management

3. Manual Entry in SAP R/3 SAP R/3 RLINK-QM LIMS System Lab Entry PI-BATCH PI Method 1

4. Manual Entry in SAP

5. Objectives Met by Method 1 Provide Data Required by Enterprise to Validate Products Produced and Materials Purchased

6. Objectives Missed by Method 1 Capture and Store the Data to Improve, Control, Analyze, and Diagnosis the Process Support the Laboratory Functions and Laboratory management Loss of data required to Trace Business to Process Problems

7. LIMS System Integration to SAP SAP R/3 RLINK-QM LIMS System Lab Entry PI-BATCH PI Method 2 Limited Data Transfer to PI

8. Objectives Met by Method 2 Provide Data Required by Enterprise to Validate Products Produced and Materials Purchased Support the Laboratory Functions and Laboratory management Limited capture of data for analysis

9. Objectives Missed by Method 2 Limited, Capture and Store of Data to Improve, Control, Analyze, and Diagnosis the Process Loss of data required to Trace Business to Process Problems

10. RLINK-QM Integration to SAP SAP R/3 RLINK-QM LIMS System Lab Entry PI-BATCH PI Method 3 If no LIMS System Available Manual Entry Requires RLINK To transfer all Required data

11. Prototype from CSN

13. OSI Software, Inc.

26. Objectives Met by Method 3 Provide Data Required by Enterprise to Validate Products Produced and Materials Purchased Capture and Store the Data to Improve, Control, Analyze, and Diagnosis the Process Trace Business to Process Problems Limited Support of the Laboratory Functions

27. Objectives Missed by Method 3 Support the Laboratory Functions and Laboratory management unless LIMS system integrated

28. Features of RLINK-QM Provide Data Required by Enterprise to Validate Products Produced and Materials Purchased Capture and Store the Data to Improve, Control, Analyze, and Diagnosis the Process Automated Usage Decision, Validation and Closure of results ProcessBook and PI-Batch Analysis Storage Batch, Lot, Product, Recorder, Recorder Date in addition to sample values Validation and Closure of results Specification Storage Support of QM results for Single Value Sample Value Characteristic Value Limited Support of the Laboratory Functions, Interface to LIMS systems possible

29. RLINK –QM January, 2000