Replacing LIMS Systems with SAP QM

ASUG Annual Conference May 2011

Mike Krug, QMS Inc., Beate Lindqvist, SAP AG
May 2011

Session Code: 2706

Public
Learning Points

1. History of LIMS, SAP QM and the QM-IDI

(Instrument Data Interface).

2. Evaluation of typical LIMS functionality and

SAP's solution to address these
requirements.

3. See some examples of typical laboratory

processes covered by QM with SAP ERP.

4. Learn about the latest updates in QM with

SAP ERP.

5. See how you can increase your efficiency by

using quality management (QM) as a LIMS in
all your labs.

© 2011 SAP AG. All rights reserved. Public 2

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

© 2011 SAP AG. All rights reserved. Public 3

History of LIMS and SAP QM
History of LIMS & SAP QM

LIMS Systems SAP QM

Laboratory Information Management System Available since the R/3 3.0 Days.
(LIMS).
Initially offered “Quality Assurance” functions.
Developed for Laboratories, specifically
around testing. Was enhanced significantly in 4.0b
(calibrations), 4.7 (stability studies), 5.0
Typically found in pharmaceutical and other (multiple specs …).
process industries.
Strength was around COA generation
Historically incorporating more “Quality
Control” capabilities along with reporting and because of its tight integration with other
statistical analysis, e.g. modules (SD, MM).
• Sample Management
• Calibrations
QM-IDI (QM Instrument Data Interface) to
• SPC
connect SAP with the LIMS systems.

Initially was the “Hands Down” choice for

laboratories that needed to do a lot (> 1
million) samples per year.

© 2011 SAP AG. All rights reserved. Public 5

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

Use SAP QM, a LIMS solution, and connect via QM-IDI interface
QM for Quality Assurance
Product Testing Requirements repository
Ensures product isn’t used or sold until it meets
QA requirements
COA generation
Vendor evaluation

LIMS for Quality Control

Test capturing
Calibration
Sample Management
Interfacing to Lab Equipment
Reporting and SPC

© 2011 SAP AG. All rights reserved. Public 6

A Side-by-side Comparison LIMS vs. SAP QM
Data Entry / Usability
Screens 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 familiarize
themselves with SAP just as quickly as a LIMS
system.
Test Equipment Integration
Interfacing to lab equipment is not easy and is
typically not standard.
Complexity is dependent on type and capabilities of
test equipment and not the software component that
is interfacing to it.
In either system additional programming and
development is most likely necessary.
© 2011 SAP AG. All rights reserved.
Calibration
For LIMS solutions dependent on software vendor.
SAP’s solution along with its integration to PM as a
strong option.
Many customers (including pharma customers) are
starting to use SAP calibrations.
Reporting / SPC
Many companies use a bolt-on statistical package
like NWA (Northwest Analytics).
SAP supports dumping of data to statistical
packages with the QM-STI. Update of statistical tools
within SAP, e.g. via QM Evaluation Cockpit.
LIMS is sometimes still seen to be stronger option,
although SAP is typically workable.
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Today: Common and Central Approach to LIMS
Enterprise LIMS

To overcome the challenges of the traditional LIMS in terms of

Isolated platforms
Lack of common source and visibility
Redundancy of master data
Numerous interfaces
Lack of traceability etc.

Reduction of Common Audit

interfaces Trail and overall
and complexity of traceability
infrastructure => cost
reduction!

Compliance with Reduction of data

Regulations & Industry redundancy and
Standards via general visibility of
and uniform approach information

© 2011 SAP AG. All rights reserved. Public 8

Evaluation of Typical LIMS
Functionality and SAP's Solution
Typical Requirements Towards a LIMS

Sample management - flexible Copy results from former tests

Bar codes Change control and audit trail

Stability studies Digital signatures

Supporting Laboratory processes Flexible reporting capabilities

Worklist of their open inspections for lab Detailed corrective and preventive actions
technician process for a detected issue

Detailed documentation of results Certificates handling

Different ways of results recording (e.g. Comprehensive authorization concept

across samples or inspection lots) Calibration of test equipments
Calculated results …
Interfacing with test equipments for direct
upload of results
Document management

© 2011 SAP AG. All rights reserved. Public 10

 QM with SAP: A Comprehensive & Integrated Solution for
All Industries

QM with SAP ERP can be applied as laboratory information and

management system (LIMS) or as Computer Aided Quality (CAQ) System.

Machinery & Construction Chemicals Consumer Products High Tech Automotive Pharmaceuticals …

Advantages compared to separate CAQ/LIMS systems:

High integration into other SAP business processes
No redundant master data
No interfaces 5600 customers
and 200
references
© 2011 SAP AG. All rights reserved. Public 11
Examples
Using QM with SAP as LIMS
Handling of Samples, Identification of Samples
Inspection Lots and Physical Samples in SAP

Different types of physical samples: primary,

Inspection
Lot pooled and reserve samples.
Results documentation for each physical
sample.
Sample records created with the inspection lot
or later.
Planned and unplanned physical samples.
Trigger additional inspection for existing sample.
Bundling of samples via “physical sample
Lab 1 Lab 2 Lab 3
drawing”.
Dispatch of different samples to different labs.
Printing of barcode labels for further
identification.

© 2011 SAP AG. All rights reserved. Public 13

Sample Management at Goods Receipt Inspection

Physical Sample Labels

with barcodes for all physical
sample types
New Sample Drawing Instruction
with information about distribution
of samples

© 2011 SAP AG. All rights reserved. Public 14

Flexible Selection of Specifications During Inspection Lot
Creation

After assignment of
inspection plan manual
sample calculation to
trigger flexible selection of
characteristics and
specifications.

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).
© 2011 SAP AG. All rights reserved. Public 15
Stability Studies

GMP-Requirement: Stability test for new products

Continuous tests of durability
Research oriented tests
Flexible Assignment
Bill of material of Specifications
First
Investigation

Inspection
Lot
manual
Initial Sample

Schedule Available Objects

Scheduling
Strategy
3 Month 6 Month
Test plan 1
with Inspection Inspection
inspection Lot Lot
series of 3, 6,
9, ... months
Sample at 8°

Test plan 2
3 Month
with
Inspection
inspection Lot
series (3, 9,
Sample at 21° 12,... month)
© 2011 SAP AG. All rights reserved. Public 16
Flexibility in Triggering Laboratory processes

Planning Scheduling

Sample Sample Billing

Test Dispatch Execution and CoA
Schedule

Inspection
Plan Sample Results Certificate
Management Recording of Analysis
Specification
Service Entry
Planned

Capacity- Validation Invoice

Inspection Planning (or internal
Method activities)
Q-Data-
Exchange

Flexible
Request
Specifications
Unplanned

Sales Order Inspection

Service Order Plan
Specification
Inspection
Method

© 2011 SAP AG. All rights reserved. Public 17

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, number
of decimal places
Entered value will be stored in the field “original value”.
SAP standard procedures
Output according to input
Output of significant digits
Input date

© 2011 SAP AG. All rights reserved. Public 18

Input Processing: Example

Procedure: Date

© 2011 SAP AG. All rights reserved. Public 19

Calibration
Covered via Integration of QM and PM Functionality

Scheduling Order Inspection Calibration

Planning
Release lot creation inspection

Maintenance
task list
Equipment,
Functional
location Release !
Insp.lot Insp.lot
Maintenance PM order
plan
CS order

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
© 2011 SAP AG. All rights reserved. Public 20
Results Copy Functionality

Option 1: Copy results automatically

during sample calculation

Option 2: Copy results automatically

during results recording

Option 3: Manual selection of an

inspection lot during results recording

Transfer Log

© 2011 SAP AG. All rights reserved. Public 21

Supporting regulatory compliance

Digital Signature in QM
Sample Drawing
Results Recording
Usage Decision
Quality Notifications
Multiple Signature Methods
Signature Strategies

Electronic Batch Record (EBR)

Deviation Analysis

Audit Trail Functionality

Cross-Application

Change Management

Batch Traceability –
Batch Information Cockpit

© 2011 SAP AG. All rights reserved. Public 22

Flexible Reporting Capabilities

QM Cockpit for Evaluations

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

Queries & figures via SAP NetWeaver BI

Analyze data from…
Notifications / Tasks
Audits
inspection lots
Predefined queries

Supplier evaluation
Quality of purchased parts
Quality Scores
Audit Results
© 2011 SAP AG. All rights reserved. Public 23
QM Evaluation Cockpit
Two Examples

Pareto Chart to show

defect frequencies

Comparison of
characteristics

© 2011 SAP AG. All rights reserved. Public 24

Quality Notifications
Problem and Complaint Management – CAPA Process

Workflow
Classification
Problem and
Quality-related costs
Complaint
Management Follow-up actions with standard examples
Solution Database
Web-based entry via SAP MII

Corrective and Status Management

Preventive Action Tracking and Monitoring
Use of Catalogs

QM Evaluation cockpit for ad-hoc reporting

Predefined queries and key figures in SAP NetWeaver BI
Quality Supplier evaluation
Analytics
Full-text search

© 2011 SAP AG. All rights reserved. Public 25

Certificate Process

Individual certificate profiles

Content and scope (characteristics)
Data origin (across supply chain)
Outbound certificates
For production batches
For deliveries (multi-level)
Inbound certificates from suppliers
Electronic quality data exchange options
Integrated with customer/supplier data
Archiving

© 2011 SAP AG. All rights reserved. Public 26

 Test Equipment Interfacing
Possible Ways with SAP ERP

QM with SAP ERP used as Enterprise LIMS

PCo QM-IDI Enterprise Service Simple Data

(Plant Connectivity) Interface (SOA) Transfer

Complementary ES Bundles RS232 serial interface

Connectivity Partner Product “Integration of QM
Framework for (no full-blown LIMS, Systems (IQM)” and File transfer
external devices e.g. IDOS, “Easy Inspection
(PCo) Dr. Eilebrecht SSE *) Planning (EIP)” Interface Boxes
(e.g. Steinwald)
Data Agents Direct integration, Flexible Web
e.g. with CDS Services Keyboard Wedges

Steinwald interface box; Complex Test Equipment QM Data Exchange with Simple Test Equipments
Simple Test Equipments (e.g. HPLC) consumer applications (e.g. (e.g. balances, colorimeter
SAP MII, 3rd party systems) etc.

MDS – Manufacturing Data Services / CDS – Chromatography Data Systems

HPLC – High Performance Liquid Chromatography / MII – SAP Manufacturing Integration and Intelligence * IDOS and Dr. Eilebrecht SSE partners for QC interfacing
© 2011 SAP AG. All rights reserved. Public 27
Latest Updates of SAP QM
SAP Developments Towards LIMS in the Latest Releases
SAP Enterprise (4.7)
Stability Study
Flexible inspection specifications
Input Processing
Copy Inspection Results
Analysis of stability studies via
SAP NetWeaver BI
SAP ERP 6.0
Multiple Specifications
Operation Completion
QM Evaluation Cockpit
© 2011 SAP AG. All rights reserved.
EhP3 for SAP ERP 6.0
Dual-control principle for results
recording
Enhanced digital signature also for
Quality Notifications, multilevel
signature strategies
Extended QM Cockpit for Evaluations:
Quality Notification and components
Extended Search for Quality Notifications
EhP4 for SAP ERP 6.0
Enhanced Quality Notifications
Documentation of issues
Information exchange
Analysis of issues
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Summary and Outlook
Typical Requirements Towards a LIMS

Sample management - flexible Copy results from former tests

Bar codes Change control and audit trail

Stability studies Digital signatures

Supporting Laboratory processes Flexible reporting capabilities

Worklist of their open inspections for lab Detailed corrective and preventive actions
technician process for a detected issue

Detailed documentation of results Certificates handling

Different ways of results recording (e.g. Comprehensive authorization concept

across samples or inspection lots) Calibration of test equipments
Calculated results …
Interfacing with test equipments for direct
upload of results
Document management

SAP can!

© 2011 SAP AG. All rights reserved. Public 31

Benefits of Using QM with SAP
Along the entire supply chain

Draw, prepare
Trigger Capture results
and distribute Decide on Usage
Inspection and issues
samples
Re-use master data Digital signature Processing configuration Digital signature
Different inspection Preplanning of sample Digital signature Release /block batch
types (goods drawing
Adjustment of specifications Multiple specifications
movement, order
Bundling of samples
release, scheduling, Input processing Follow-up actions
stability study,
Results copy Billing of analysis
manual …)
Operation completion
Direct link to other
processes and data Multiple specifications
Flexible inspections Trigger CAPA
Draw additional samples

… Complaints …

Retest of reserved samples

Flexible evaluation of results
Copy results
…

© 2011 SAP AG. All rights reserved. Public 32

SAP Provides Enterprise LIMS plus Integration
Supporting Total Quality Management

Inventory Mgmt. Test Equipment

Workflow,
Batch Mgmt. Quality- Related Management
Authorization
Change Handling Costs
Concept
CAPA Calibration,
Data Warehouse Revenues Planning &
QM Manual
Document Mgmt. Execution

Enterprise
Human Finance &
Logistics Asset
Resources Controlling
Management

Enterprise Quality Management

Research &
Procurement Production Sales
Development

Inspection Planning In-/Post-Process Control

Stability Study
SPC-Statistical Process Control Certificate of Analysis
Flexible Specifications Supplier Release & CoA
Interfaces for Measurement (CoA)
Recipe Management Goods Receipt Devices
Inspection Quality Data Exchange
Advanced Product Deviation Management
Quality Planning Sample Management Electronic Batch Record Billing of Analysis
(APQP/FMEA) Audit Management Integration to SAP MII

© 2011 SAP AG. All rights reserved. Public 33

Business Reasons to Replace LIMS with SAP QM
5 Key Points to Take Home
Integration
Increased need for tight integration between quality, manufacturing and R&D throughout
supply chain.

Cost and Process Efficiency

Increased 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 Approach

Testing 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 Visibility

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

Increasing Issues with LIMS providers

Stability of LIMS providers.

© 2011 SAP AG. All rights reserved. Public 34

More than 200 Reference Customers for QM wit SAP
Examples

Automotive Chemicals Consumer Products

BMW Manufacturing Corporation BASF
BASFAG
AG Arla
ArlaFoods
FoodsAmba
Amba
USA Germany Denmark

Brose Fahrzeugteile GmbH & Co. KG Clariant Michael Foods, Inc.

Germany Germany USA

Continental Teves AG & Co. oHG Degussa Roehm GmbH McCormick & Company Inc.
Germany Germany USA

Grammer AG Dow Corning Corp. Dr. August Oetker

Germany USA Germany

ZF Passau GmbH DSM Fine Chemicals

Germany Austria

IM&C High Tech Life Sciences

Andreas Stihl AG & Co. 3M Espe Abbott Laboratories
Germany Germany USA

Balluff GmbH Qimonda Merckle ratiopharm GmbH

Germany Germany Germany

Briggs & Stratton Corporation Molex Incorporated Roche Diagnostics

USA USA Germany

Kaeser Kompressoren GmbH Roche Diagnostics Corp. Sanofi - Aventis Deutschland GmbH
Germany USA Germany

August Rüggeberg GmbH & Co. KG Solvay Pharmaceuticals B.V.

Germany Netherlands

© 2011 SAP AG. All rights reserved. Public 35

Information on Quality Management with SAP
In the SAP Service Marketplace

Brochures
Quality Management with SAP ERP
SAP QM as Enterprise LIMS
Stability Studies with SAP ERP
Success Story with SPIMACO
Further brochures on QM and more …

https://service.sap.com/qm
Media Library
(requires login credentials)

© 2011 SAP AG. All rights reserved. Public 36

Thank You!
Session Code: 2706

Contact information:

Mike Krug Beate Lindqvist, Product Owner QM

QMS Inc. SAP AG, Germany
mkrug@qmsinc.com beate.lindqvist@sap.com
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