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Editor's Notes

• #2: Whether your LAB is best served by SAP QM or LIMS is a contentious topic. One that has been debated for over 20 years, and shows no signs of letting up. Proponents of each approach are fervent in their advocacy of their chosen solution. In order to reduce TCO Executives of major corporations are insistent on the use of SAP QM whereas LAB personnel are reluctant give up on their LIMS which has been tailored to match their workflows. In this short presentation we will delve into the world of fantasy to describe the battle for dominion of the LAB using LOTR as an analogy. We will also delve into the world of reality, at least my personal reality, and describe how SAP QM has been used to support LAB operations. But first, Fantasy
• #3: Over 25 years experience in informatics with a focus on MES/EBR and applications for the QC lab in a variety of industries. During that time I have witnessed the evolution and occasional revolution of lab informatics from rudimentary excel spreadsheets to the current web based, integrated systems.
• #5: Initially the power of the ring was weak….. Initially focused on Quality Assurance Product Release CoA generation – tight integration with SD and MM Vendor evaluation QM-IDI interface developed by SAP to integrate the quality control capabilities of LIMS – Encouraged LIMS vendors through a certification process to support this interface. Instrument Calibrations using PM module 4.0b Stability Studies using Module – 4.7 Asset Life-Cycle Management (maintenance planning and scheduling) Materials Management (material master, batch management, and bills of materials) Instrument Interfacing – QM-IDI through LIMSLINK or ohers – ES Bundles – Flexible web services using PI middleware – Direct Connect QM is Tightly integrated with MM, PP, SD, PM and other modules Brief history of LIMS Developed for LABS around sample management and testing Includes many deep functional components including Sample Management Instrument Management (Calibration) Instrument Interfacing – Typically large repository of “ready built” interfaces for Test Result capture Reporting and SPC Stability Environmental Monitoring
• #6: Through the one ring the power of Sauron increased
• #7: Through the one ring the power of Sauron increased
• #8: Through the one ring the power of Sauron increased
• #9: Through the one ring the power of Sauron increased
• #10: Through the one ring the power of Sauron increased
• #11: NEW alliances: While traditional LIMS was good at sample and result management it wasn’t so good at handling manual operations. Operators still need to collect the sample, gather reagents, get instruments up and running, test the sample and so on. Regulated QC Labs and other labs that operate through Standard Operating procedures execute many steps in each test, with each step being following sequentially. Along came LES that enabled and controlled this workflow SDMS The integrated platform The power of the LAB was increasing too. Although not normally associated with the realm of the QC LAB, Research Scientists became an unexpected ally. They were busy developing new science at a pace that only the nimble LIMS could support. The realization that linking the whole process from Research to Development to Manufacturing provided significant cost and productivity gains energized the resistance. With these new alliances The people of the LAB Finally awoke – united and determined to continue the battle
• #12: NEW alliances: While traditional LIMS was good at sample and result management it wasn’t so good at handling manual operations. Operators still need to collect the sample, gather reagents, get instruments up and running, test the sample and so on. Regulated QC Labs and other labs that operate through Standard Operating procedures execute many steps in each test, with each step being following sequentially. Along came LES that enabled and controlled this workflow SDMS The integrated platform The power of the LAB was increasing too. Although not normally associated with the realm of the QC LAB, Research Scientists became an unexpected ally. They were busy developing new science at a pace that only the nimble LIMS could support. The realization that linking the whole process from Research to Development to Manufacturing provided significant cost and productivity gains energized the resistance. With these new alliances The people of the LAB Finally awoke – united and determined to continue the battle
• #13: NEW alliances: While traditional LIMS was good at sample and result management it wasn’t so good at handling manual operations. Operators still need to collect the sample, gather reagents, get instruments up and running, test the sample and so on. Regulated QC Labs and other labs that operate through Standard Operating procedures execute many steps in each test, with each step being following sequentially. Along came LES that enabled and controlled this workflow SDMS The integrated platform The power of the LAB was increasing too. Although not normally associated with the realm of the QC LAB, Research Scientists became an unexpected ally. They were busy developing new science at a pace that only the nimble LIMS could support. The realization that linking the whole process from Research to Development to Manufacturing provided significant cost and productivity gains energized the resistance. With these new alliances The people of the LAB Finally awoke – united and determined to continue the battle
• #14: NEW alliances: While traditional LIMS was good at sample and result management it wasn’t so good at handling manual operations. Operators still need to collect the sample, gather reagents, get instruments up and running, test the sample and so on. Regulated QC Labs and other labs that operate through Standard Operating procedures execute many steps in each test, with each step being following sequentially. Along came LES that enabled and controlled this workflow SDMS The integrated platform The power of the LAB was increasing too. Although not normally associated with the realm of the QC LAB, Research Scientists became an unexpected ally. They were busy developing new science at a pace that only the nimble LIMS could support. The realization that linking the whole process from Research to Development to Manufacturing provided significant cost and productivity gains energized the resistance. With these new alliances The people of the LAB Finally awoke – united and determined to continue the battle
• #15: The eye of Sauron wants to see all Labs using the power of the one ring. If you have been mandated to use SAP QM rather than LIMS Manual entry of Results Management of Raw left at the instrument level No complex instrument integration requirements Suitable for Distribution Centers and warehouses But what if there is a need to directly transfer results from the instruments to QM? While you could directly connect simple instruments create interfaces to each of your intruments Choosing a configurable 3rd Party Solution with the capabilities to process data can eliminate the cost of effort required to implement lab specific processing and calculations in SAP
• #16: So a simple third party tool such as LIMSLink can be used to automate some routine manual tasks in the lab: Calculations can be performed within the interface prior. Choosing a configurable 3rd Party Solution with the capabilities to process data can eliminate the cost of effort required to implement lab specific processing and calculations in SAP Limit checks can be performed in the interface prior to sending data to SAP Transfer results automatically to SAP You may have eliminated LIMS but you have replaced it with another system IT Perspective Typically still haven’t addressed raw data management
• #17: Original Best of Breed Approach CoA, Final release from SAP QM-IDI interface - certification LIMS Instrument Integration Reagent Management Instrument Management – calibration Sample Management EM Stability Studies Raw Data Management Integration to SDMS (NuGenesis, OpenLab, Nexxis) Raw data and associated metadata Tight integration to major CDS such as Dionex Chromeleon and Waters Empower It should be noted that even within the same landscape the data exchange between SAP and LIMS varies considerably From simply exchanging Lot Level information – for example Lot Usage Decision (and perhaps a key characteristic such as concentration for product grading by SAP) where specifications are maintained within LIMS to Full blown exchange of specifications and test results. The whole issue of Master data ownership – another major discussion topic that we won’t have time to discuss today.
• #18: Bench level workflow control A LES provides a structured platform that eliminates a lot of paper while automating and controlling testing procedures at the bench level. Sample information, test execution, lab consumables inventory control, instrument calibration can all be integrated to ensure that procedures are always followed and to automate the flow of information. Ability to review by exception. The lab is able to operate more efficiently as errors are reduced , less time is spent on review and rework, and information is readily accessible when needed. The ROI can be huge with some studies showing an annual savings in the hundreds of thousands through the implementation of just a handful of the most complex methods that require significant documentation efforts. Sample management in QM Bench level workflow control in an external system (e.g., LES) Use triggers from SAP to initiate test execution in the LES Transfer data from SAP to populate electronic worksheets in the LES Integrate the LES with other systems to automate and control test execution Perform calculations and result approval within LES prior to reporting to SAP Transfer results automatically Some of you may recognize this as the THIN LIMS approach that was advocated by SAP proponents some 5 years ago. Expanding the depth of the QM implementation and extending the functionality of LES Will Lab personnel have to access two separate systems to accomplish their work? In practice what we have seen: LES functionality has been built out to include sample management activities Some failures with reported only 50% of the required functionality being available without significant additional effort in both QM and LES build out. Project shelved and reverted to LIMS/ELN solution
• #19: Typical Environments High Volume Large number of Analysts High Level of Automation Required Who “owns” the data? Specifications Sample Scheduling Results Who is “master”, who is “slave” Who/How are changes managed
• #20: The eye of the Sauron is watching down on all labs where SAP is used corporately. Sauron has instructed his wraiths to ensure that all LABS shall use the power of the one ring. Fear is spreading in these labs where sophisticated informatics systems are under the threat of replacement with something much less than they currently have. The storm clouds are forming and Mt. Doom is increasingly visible on the horizon. But wait maybe the resistance is itself delusional. Maybe Sauron and the Power of the One ring is the light.
• #22: One Ring to Rule them all: Yes the enterprise must have visibility to pertinent LAB data One Ring to find them: and yes the enterprise must identify the systems that contain the pertinent lab data (is raw data pertinent?) One Ring to bring them all And in the darkness bind them: : But does BIND mean assimilate or integrate. We all know what Sauron believes. What do you think?
• #23: One Ring to Rule them all: Yes the enterprise must have visibility to pertinent LAB data One Ring to find them: and yes the enterprise must identify the systems that contain the pertinent lab data (is raw data pertinent?) One Ring to bring them all And in the darkness bind them: : But does BIND mean assimilate or integrate. We all know what Sauron believes. What do you think?