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

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

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

Manual Entry in SAP

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

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

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

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

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

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

Prototype from CSN

OSI Software, Inc.

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

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

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

RLINK –QM January, 2000