replacing lims systems with sap qmdocshare01.docshare.tips/files/22561/225612745.pdf · replacing...

Replacing LIMS Systems with SAP QMASUG Annual Conference May 2011Mike Krug, QMS Inc., Beate Lindqvist, SAP AGMay 2011

Public

Session Code: 2706

© 2011 SAP AG. All rights reserved. 2Public

Learning Points

1. History of LIMS, SAP QM and the QM-IDI(Instrument Data Interface).

2. Evaluation of typical LIMS functionality andSAP's solution to address theserequirements.

3. See some examples of typical laboratoryprocesses covered by QM with SAP ERP.

4. Learn about the latest updates in QM withSAP ERP.

5. See how you can increase your efficiency byusing quality management (QM) as a LIMS inall your labs.


Agenda

History of LIMS and SAP QM

Evaluation of Typical LIMS Functionality and SAP's Solution

Examples for using SAP QM as LIMS

Latest Updates of SAP QM

Summary and Outlook

History of LIMS and SAP QM


History of LIMS & SAP QM

LIMS Systems

Laboratory Information Management System(LIMS).

Developed for Laboratories, specificallyaround testing.

Typically found in pharmaceutical and otherprocess industries.

Historically incorporating more “QualityControl” capabilities along with reporting andstatistical analysis, e.g.• Sample Management• Calibrations• SPC

Initially was the “Hands Down” choice forlaboratories that needed to do a lot (> 1million) samples per year.

SAP QM

Available since the R/3 3.0 Days.

Initially offered “Quality Assurance” functions.

Was enhanced significantly in 4.0b(calibrations), 4.7 (stability studies), 5.0(multiple specs …).

Strength was around COA generationbecause of its tight integration with othermodules (SD, MM).

QM-IDI (QM Instrument Data Interface) toconnect SAP with the LIMS systems.


Use SAP QM, a LIMS solution, and connect via QM-IDI interface

QM for Quality AssuranceProduct Testing Requirements repositoryEnsures product isn’t used or sold until it meetsQA requirementsCOA generationVendor evaluation

LIMS for Quality ControlTest capturingCalibrationSample ManagementInterfacing to Lab EquipmentReporting and SPC

Historically: “Best of Breed” ApproachCombining both, LIMS & SAP QM


A Side-by-side Comparison LIMS vs. SAP QM

Data Entry / UsabilityScreens look about identical LIMS and SAP(sometimes not as pretty).Built-in customization in LIMS vs. preparation steps(BUT: flexibility of configuration) in SAP.Lab users historically have been able to familiarizethemselves with SAP just as quickly as a LIMSsystem.

CalibrationFor LIMS solutions dependent on software vendor.SAP’s solution along with its integration to PM as astrong option.Many customers (including pharma customers) arestarting to use SAP calibrations.

Test Equipment IntegrationInterfacing to lab equipment is not easy and istypically not standard.Complexity is dependent on type and capabilities oftest equipment and not the software component thatis interfacing to it.In either system additional programming anddevelopment is most likely necessary.

Reporting / SPCMany companies use a bolt-on statistical packagelike NWA (Northwest Analytics).

SAP supports dumping of data to statisticalpackages with the QM-STI. Update of statistical toolswithin SAP, e.g. via QM Evaluation Cockpit.

LIMS is sometimes still seen to be stronger option,although SAP is typically workable.


Today: Common and Central Approach to LIMSEnterprise LIMS

To overcome the challenges of the traditional LIMS in terms ofIsolated platformsLack of common source and visibilityRedundancy of master dataNumerous interfacesLack of traceability etc.

Reduction ofinterfacesand complexity ofinfrastructure => costreduction!

Common AuditTrail and overalltraceability

Reduction of dataredundancy andvisibility ofinformation

Compliance withRegulations & IndustryStandards via generaland uniform approach

Evaluation of Typical LIMSFunctionality and SAP's Solution


Typical Requirements Towards a LIMS

Sample management - flexible

Bar codes

Stability studies

Supporting Laboratory processes

Worklist of their open inspections for labtechnician

Detailed documentation of results

Different ways of results recording (e.g.across samples or inspection lots)

Calculated results

Interfacing with test equipments for directupload of results

Document management

Copy results from former tests

Change control and audit trail

Digital signatures

Flexible reporting capabilities

Detailed corrective and preventive actionsprocess for a detected issue

Certificates handling

Comprehensive authorization concept

Calibration of test equipments

…


QM with SAP: A Comprehensive & Integrated Solution forAll Industries

Chemicals Consumer Products High Tech Automotive Pharmaceuticals …

QM with SAP ERP can be applied as laboratory information andmanagement system (LIMS) or as Computer Aided Quality (CAQ) System.

Machinery & Construction

Advantages compared to separate CAQ/LIMS systems:High integration into other SAP business processesNo redundant master dataNo interfaces 5600 customers

and 200references

ExamplesUsing QM with SAP as LIMS


Lab 3Lab 2Lab 1

Handling of Samples, Identification of SamplesInspection Lots and Physical Samples in SAP

Different types of physical samples: primary,pooled and reserve samples.Results documentation for each physicalsample.Sample records created with the inspection lotor later.Planned and unplanned physical samples.Trigger additional inspection for existing sample.Bundling of samples via “physical sampledrawing”.Dispatch of different samples to different labs.Printing of barcode labels for furtheridentification.

InspectionLot


Sample Management at Goods Receipt Inspection

Physical Sample Labelswith barcodes for all physicalsample types

New Sample Drawing Instructionwith information about distributionof samples


Flexible Selection of Specifications During Inspection LotCreation

After assignment ofinspection plan manualsample calculation totrigger flexible selection ofcharacteristics andspecifications.

Benefits:For flexible adjustment of specification data before starting the actual test!E.g. for service-based inspections.Also applicable for results recording (adjustment of specs).


ScheduleStrategy

Initial Sample

Test plan 1withinspectionseries of 3, 6,9, ... months

Test plan 2withinspectionseries (3, 9,12,... month)

InspectionLot

InspectionLot

InspectionLotmanual

Bill of material

InspectionLot

Sample at 21°

Sample at 8°

Stability Studies

GMP-Requirement: Stability test for new productsContinuous tests of durabilityResearch oriented tests

Available ObjectsScheduling

Flexible Assignmentof Specifications

3 Month 6 Month

3 Month

FirstInvestigation


Service Entry

Request FlexibleSpecifications

Sales OrderService Order

Flexibility in Triggering Laboratory processes

Planning Scheduling

TestSchedule

Billingand CoA

SampleExecution

InspectionPlanSpecificationInspectionMethod

InspectionPlanSpecificationInspectionMethod

SampleManagementCapacity-Planning

ResultsRecordingValidation

Certificateof AnalysisInvoice(or internalactivities)Q-Data-Exchange

SampleDispatch

Pla

nned

Unp

lann

ed


Calculated Results

Idea of “Input Processing”:Translation of entered results (average and single values) according to defined rules.

SAP Solution:Provided via an exchangeable program-part (Business Add-In)

Fields that can be changed: entered value, attribute, origin of results data, numberof decimal places

Entered value will be stored in the field “original value”.SAP standard procedures

Output according to inputOutput of significant digitsInput date


Input Processing: Example

Procedure: Date


CalibrationCovered via Integration of QM and PM Functionality

Including …Confirmation of used equipment => tracking of equipment (where used)

Update of equipment status incl. measurement info

Test before and after calibration

Audit trail and digital signature

Planning Scheduling Calibrationinspection

Inspectionlot creation

OrderRelease

Release !

Maintenancetask list

Equipment,Functional

location

Maintenanceplan

Insp.lot Insp.lotPM order

CS order


Results Copy Functionality

Option 1: Copy results automaticallyduring sample calculation

Option 2: Copy results automaticallyduring results recording

Transfer Log

Option 3: Manual selection of aninspection lot during results recording


Supporting regulatory compliance

Digital Signature in QMSample DrawingResults RecordingUsage DecisionQuality NotificationsMultiple Signature MethodsSignature Strategies

Electronic Batch Record (EBR)

Deviation Analysis

Audit Trail FunctionalityCross-Application

Change Management

Batch Traceability –Batch Information Cockpit


Flexible Reporting Capabilities

Ad-hoc evaluations of quality notifications and resultsSpecific graphics types:—Pareto Chart—Scatter Plot—Control Chart …

QM Cockpit for Evaluations

Analyze data from…Notifications / TasksAuditsinspection lotsPredefined queries

Queries & figures via SAP NetWeaver BI

Quality of purchased partsQuality ScoresAudit Results

Supplier evaluation


QM Evaluation CockpitTwo Examples

Pareto Chart to showdefect frequencies

Comparison ofcharacteristics


Quality NotificationsProblem and Complaint Management – CAPA Process

Status ManagementTracking and MonitoringUse of Catalogs

WorkflowClassificationQuality-related costsFollow-up actions with standard examplesSolution DatabaseWeb-based entry via SAP MII

Problem andComplaintManagement

Corrective andPreventive Action

QM Evaluation cockpit for ad-hoc reportingPredefined queries and key figures in SAP NetWeaver BISupplier evaluationFull-text search

QualityAnalytics


Individual certificate profilesContent and scope (characteristics)Data origin (across supply chain)

Outbound certificatesFor production batchesFor deliveries (multi-level)

Inbound certificates from suppliersElectronic quality data exchange optionsIntegrated with customer/supplier dataArchiving

Certificate Process


Test Equipment InterfacingPossible Ways with SAP ERP

MDS – Manufacturing Data Services / CDS – Chromatography Data SystemsHPLC – High Performance Liquid Chromatography / MII – SAP Manufacturing Integration and Intelligence * IDOS and Dr. Eilebrecht SSE partners for QC interfacing

Simple Test Equipments(e.g. balances, colorimeteretc.

QM Data Exchange withconsumer applications (e.g.SAP MII, 3rd party systems)

Complex Test Equipment(e.g. HPLC)

Steinwald interface box;Simple Test Equipments

QM with SAP ERP used as Enterprise LIMS

PCo(Plant Connectivity)

QM-IDIInterface

Enterprise Service(SOA)

Simple DataTransfer

ConnectivityFramework forexternal devices(PCo)

Data Agents

ComplementaryPartner Product(no full-blown LIMS,e.g. IDOS,Dr. Eilebrecht SSE *)

Direct integration,e.g. with CDS

ES Bundles“Integration of QMSystems (IQM)” and“Easy InspectionPlanning (EIP)”

Flexible WebServices

RS232 serial interface

File transfer

Interface Boxes(e.g. Steinwald)

Keyboard Wedges

Latest Updates of SAP QM


SAP Developments Towards LIMS in the Latest Releases

SAP Enterprise (4.7)Stability StudyFlexible inspection specificationsInput ProcessingCopy Inspection ResultsAnalysis of stability studies viaSAP NetWeaver BI

SAP ERP 6.0Multiple SpecificationsOperation CompletionQM Evaluation Cockpit

EhP3 for SAP ERP 6.0Dual-control principle for resultsrecordingEnhanced digital signature also forQuality Notifications, multilevelsignature strategiesExtended QM Cockpit for Evaluations:Quality Notification and componentsExtended Search for Quality Notifications

EhP4 for SAP ERP 6.0Enhanced Quality Notifications

Documentation of issuesInformation exchangeAnalysis of issues

Summary and Outlook


Typical Requirements Towards a LIMS

Sample management - flexible

Bar codes

Stability studies

Supporting Laboratory processes

Worklist of their open inspections for labtechnician

Detailed documentation of results

Different ways of results recording (e.g.across samples or inspection lots)

Calculated results

Interfacing with test equipments for directupload of results

Document management

Copy results from former tests

Change control and audit trail

Digital signatures

Flexible reporting capabilities

Detailed corrective and preventive actionsprocess for a detected issue

Certificates handling

Comprehensive authorization concept

Calibration of test equipments

…

SAP can!


Benefits of Using QM with SAPAlong the entire supply chain

TriggerInspection

Draw, prepareand distribute

samples

Capture resultsand issues Decide on Usage

Re-use master data

Different inspectiontypes (goodsmovement, orderrelease, scheduling,stability study,manual …)

Direct link to otherprocesses and data

Flexible inspections

Digital signature

Preplanning of sampledrawing

Bundling of samples

Processing configuration

Digital signature

Adjustment of specifications

Input processing

Results copy

Operation completion

Multiple specifications

Trigger CAPA

Draw additional samples

Digital signature

Release /block batch

Multiple specifications

Follow-up actions

Billing of analysis

Complaints …

Retest of reserved samples

Flexible evaluation of results

Copy results

…

…


SAP Provides Enterprise LIMS plus IntegrationSupporting Total Quality Management

Enterprise Quality Management

HumanResources Logistics Finance &

Controlling

EnterpriseAssetManagement

HumanResources

Workflow,AuthorizationConcept

QM Manual

Inventory Mgmt.Batch Mgmt.Change HandlingCAPAData WarehouseDocument Mgmt.

Quality- RelatedCosts

Revenues

Test EquipmentManagement

Calibration,Planning &Execution

SalesProductionProcurementResearch &Development

Stability Study

Flexible Specifications

Recipe Management

Advanced ProductQuality Planning(APQP/FMEA)

Inspection Planning

Supplier Release & CoA

Goods ReceiptInspection

Sample Management

Audit Management

In-/Post-Process ControlSPC-Statistical Process ControlInterfaces for MeasurementDevicesDeviation ManagementElectronic Batch RecordIntegration to SAP MII

Certificate of Analysis(CoA)

Quality Data Exchange

Billing of Analysis


Business Reasons to Replace LIMS with SAP QM5 Key Points to Take Home

IntegrationIncreased need for tight integration between quality, manufacturing and R&D throughoutsupply chain.

Cost and Process EfficiencyIncreased cost pressures are forcing companies to track quality costs more efficiently.Elimination of interfaces to 3rd party systems (i.e. effort for support & upgrade & license costs).

Enterprise LIMS ApproachTesting is Moving out of Laboratories - Products are tested more on front end than later.Global approach for standardized testing practices to enforce consistent product quality.Also adaptable for different business scenarios.

Transparency and VisibilityIncreasing need for quick product recall situations requiring tight traceability.Consistent, transparent and redundancy-free data.

Increasing Issues with LIMS providersStability of LIMS providers.


More than 200 Reference Customers for QM wit SAPExamples

Solvay Pharmaceuticals B.V.Netherlands

August Rüggeberg GmbH & Co. KGGermany

Sanofi - Aventis Deutschland GmbHGermany

Roche Diagnostics Corp.USA

Kaeser Kompressoren GmbHGermany

Roche DiagnosticsGermany

Molex IncorporatedUSA

Briggs & Stratton CorporationUSA

Merckle ratiopharm GmbHGermany

QimondaGermany

Balluff GmbHGermany

Abbott LaboratoriesUSA

3M EspeGermany

Andreas Stihl AG & Co.Germany

DSM Fine ChemicalsAustria

ZF Passau GmbHGermany

Dr. August OetkerGermany

Dow Corning Corp.USA

Grammer AGGermany

McCormick & Company Inc.USA

Degussa Roehm GmbHGermany

Continental Teves AG & Co. oHGGermany

Michael Foods, Inc.USA

ClariantGermany

Brose Fahrzeugteile GmbH & Co. KGGermany

Arla Foods AmbaDenmark

BASF AGGermany

BMW Manufacturing CorporationUSA

Automotive Chemicals Consumer Products

IM&C High Tech Life Sciences

Arla Foods AmbaDenmark

BASF AGGermany


Information on Quality Management with SAPIn the SAP Service Marketplace

Brochures

Quality Management with SAP ERPSAP QM as Enterprise LIMSStability Studies with SAP ERP

Success Story with SPIMACO

Further brochures on QM and more …

https://service.sap.com/qmMedia Library

(requires login credentials)

https://service.sap.com/qm

Thank You!

Contact information:

Mike KrugQMS [email protected]

Beate Lindqvist, Product Owner QMSAP AG, [email protected]

Session Code: 2706

mailto:[email protected]

mailto:[email protected]


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