SAP AG

Requirements of 21 CFR Part 11 and

Realization in mySAP ERP

SAP Tools for Validation Support

SAP AG 2005, , / 2
 ! "
The manufacturing and distribution of pharmaceuticals,
medical devices and diagnostics, food, and cosmetics are
regulated by various government agencies throughout the globe

Companies that intend to market products within specific regions

such as the U.S. or EU must comply with all applicable regulations

The U.S. FDA is considered to be the most strict in regards to the

regulations and enforcement of products marketed and sold within
the U.S.

According to the regulations the computerized system needs to be

validated

Failure will result in significant business and financial ramifications

SAP AG 2005, , / 3
 First Federal Food, Drug Ongoing: FDA
Food & & Cosmetics Act: further
Drug Law Foundation of FDA empowered by
Congress

#$ %&'((( )* *
+, - .

Product Focus Functional Focus

Medicines Law Enforcement

Biologics Federal Register
Medical Devices Safety Alerts
Food for human and animal consumption Product Approvals
Radiation emitting devices Regulation
Cosmetics

SAP AG 2005, , / 4
 - #$ $ /0 - -

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SAP AG 2005, , / 5
 8 9

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SAP AG 2005, , / 6
 #$ -

FDA GMP Non-Compliance Consequences

Costs to Costs not
Comply to
Comply

! " ( 5 .
..
?@(

# " $ %
SAP AG 2005, , / 7
 - "A - -< -

SAP AG 2005, , / 8
 B $ - !

A rising number of drug recalls suggests

how quality problems have been slipping
- through the current manufacturing
systems.

For 25 years, FDA reworks for the first

D(( 354 time the GMP-regulations

C@( FDAs main focus is the public safety,

therefore FDA has never been a protagonist
C(( regarding the change of production
248
procedures which deliver batches of
@( constant quality
176
(( For years, prescription drugs have been
so profitable there has been no real need to
@( improve their efficiency
(( Another measure of manufacturing
shortcomings: 5% to 10% of medicine thats
@( produced doesnt meet specifications and
has to be reworked or discarded
(
%%& (( (( The failure quote for semi-conductor
industry comes to 0,0001% which meets the
specification by factor 100.000 better!
WSJ.com New Prescription for Drug Makers:
Update the Plants,September 3, 2003
SAP AG 2005, , / 9
 0%
2%
4%
6%
8%
10%
12%
14%
16%
Written

SAP AG 2005, , / 10
procedures
Warning
/

Testing and
release for

GMP-News 19.03.2003
distribution
letters
Warning

Responsibilities
of quality
control unit

Lab controls-
general
requirements.
7 8

Production
record review

Batch
production
control records

Personel
qualifications
based on 21 CFR Part 211

Equipment
cleaning and
maintenance

Stability
Testing
Letters 2002 - The Top-Ten Complaints

Sampling and
testing of
process
materials and
drug products
 A 6-

21 CFR Part 11 - Electronic Records; Electronic Signatures; Final

Rule
Proposed rule - Aug. 31, 1994
Comment period closed Nov. 29, 1994
Final regulation published Mar. 20, 1997
Effective Aug. 20, 1997

Result of a 6 year long discussion between industry and FDA

Part 11 defines, under which conditions electronic records and

electronic signatures are equivalent, and as reliable and
trustworthy as paper documents and handwritten signatures

Part 11 describes conditions, how paperless systems can be

operated in compliance with GxP requirements

SAP AG 2005, , / 11
 A 6-

Little clarity, how these requirements can be implemented

Many SAP customers took a wait and see approach regarding

FDA interpretation and enforcement.

Enforcement Policy published in May 1999

FDA expects that companies take steps to ensure compliance

FDA will not accept non-compliant systems

FDA expects, that organizational measures are already

implemented

FDA acknowledges, that implementation of technical solution

takes some time

Several FDA Guidance Documents in 2002

Withdrawl of Guidance Documents in 2003

SAP AG 2005, , / 12
 < -

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SAP AG 2005, , / 13
 ) E&F (( -

General Food Law

Traceability according article 18 20
Traceability has to be guaranteed for all steps of the food
manufacturing chain
Traceability has to be ensured for all steps
Person must be identifiable, of which the company did obtain goods
Identification of the customer company must be guaranteed
Systems and procedures have to be established
The related informations have to be sent to the responsible authorities
Goods have to be characterized in a sufficient manner in order to
simplify the traceability
The objective of the traceability is the possibility of a dedicated
goods recall
Realization until January 1, 2005

SAP AG 2005, , / 14
 ! 45 4
G

EU GMP-Guideline

EU Directive 91/356 delineates the legal

requirements for EU GMP

PIC/S Guidance
Good Practices for Computerised Systems in Regulated GxP
environments

ICH Guideline Q 7A
Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients

SAP AG 2005, , / 15
 FDA Compliance and Trends

G
9

SAP Tools for Validation Support

SAP AG 2005, , / 16
 11.10b

The ability to generate accurate and complete copies of records in both human
readable and electronical form suitable for inspection, review and copying by the agency.

11.10e Use of secure, computer-generated, time-stamped audit-trails

The user-ID
Date/time stamp of operator entries when the record was created, modiefied or deleted
The transaction type (insert/delete/modified) associeated with the transaction
New value and old value after record changes

Consequences from 11.10 on electronic records

Complete audit-trail for all GMP-relevant master data and transactions in R/3
All fields that can be changed by a user must become part of electronic record
Better to activate change record logging on a table level than on field level

Electronic signature Electronic records

Interactive Automatic
process process
Front-end Back-end
based based

Logging

SAP AG 2005, , / 17
 Part 11 provides the regulatory framework for
e-records and e-signatures

Scope of Part 11 is determined by GxP (predicate rule)

What SAP R/3 functionality could be regulated?

HR Human Resources (for example, training information)
MM/WM Materials/Warehouse Management
PM Plant Maintenance
PP-PI Production Planning for Process Industries
QM Quality Management

SAP R/3 business GMP-relevant

processes GMP-relevant? SAP R/3 business
processes and
transactions
SAP AG 2005, , / 18
 4H /
Recommended FDA CGMP Hot List :
1. COR1 Create Process Order With Material
2. COR2 Change Process Order
3. ME01 Maintain Source List
4. MM01 Create Material
5. MM02 Change Material
6. MMDE Delete All Materials
7. MSC1 Create Batch
8. MSC2 Change Batch
9. QA02 Change Inspection Lot
10. QA08 Mass Change of QM Inspection Data
11. QA11 Record Usage Decision
12. QA12 Change Usage Decision
13. QA14 Change Usage Decision Without History
14. QA16 Collective Usage Decision For OK Lots
15. QA32 Inspection Lot Selection
16. QAC1 Correct Actual Quantity In Insp Lot
17. QAC2 Transfer Insp. Lot Quant.
18. QAC3 Insp. Lot Reset Sample Calculation
19. QE01 Record Results
20. QE02 Change Results
21. QE51 Worklist: Results Recording
22. QM01 Create Quality Notification
23. QM02 Change Quality Notification
24. QVM1 Inspection Lots Without Inspection Completion
25. QVM2 Inspection Lots With Open Quantities
26. QVM3 Inspection Lots Without Usage Decision
27. SA38 Execute Program
28. SU01 User master create/edit
29. BMBC Batch Information Cockpit
SAP AG 2005, , / 19
 $ *

SAP AG 2005, , / 20
 G
9

E-Signatures in mySAP ERP

E-Records in mySAP ERP

SAP AG 2005, , / 21
 I G 3 -

J *@( Signed electronic records shall contain information

associated with the signing that clearly indicates all of the
following:
The printed name of the signer
The date and time stamp (local time!) when the signature was
executed, including the date and time local to the signer when
multiple time zones are involved (see comment 101 in the preamble
of Part 11 Rule)
The meaning associated with the signature (such as review,
approval, responsibility, or authorship)

J * (( Electronic signatures that are not based on

biometrics shall:
Employ at least two distinct identification components such as an
identification code and password
Be used only by their genuine owners

SAP AG 2005, , / 22
 / < -- - < 6 -

R/3 (Security) Alert

Monitor

R/3
Lock R/3-User
Security
Wrong Password Audit Log
Re
Locked User po
Signature rt

Logging

J *C(( Use of transaction safeguards to prevent unauthorized use of passwords

and/or identification codes, and to detect and report in an immediate and
urgent manner any attempts of their unauthorized use to the system
security unit, and as appropriate, organizational management

SAP AG 2005, , / 23
 -

System signature with authorization by user ID and password

Users identify themselves by entering their user IDs and passwords. The
SAP system then executes the digital signature. The user name and ID are
part of the signed document.
No external security product necessary.
Usage of PKCS#7 standard
First shipment with release 4.6C

Digital user signature with verification

Users execute digital signatures themselves using hardware keys. External
security product necessary. The executed signatures are automatically
verified.
Crypto hardware, for example, smart card, must support the PKCS#7
standard data format. This mechanism is based on secure store and
forward mechanism.
First shipment with release 4.0B (1998)

Both signature types qualify as digital signatures as defined in

Part 11

SAP AG 2005, , / 24
 -

- - -
Computer data compilation of any An electronic signature based upon
symbol or series of symbols executed, cryptographic methods of originator
adopted, or authentication,
authorized by an individual to be the computed by using a set of rules and a set of
legally binding parameters
equivalent to the individuals handwritten such that the identity of the signer and
signature
the integrity of data can be verified

SAP AG 2005, , / 25
 - 5 -
- -
All required individual signatures in a All required individual signatures in a
signature strategy signature strategy

must be performed subsequently in one must not be performed subsequently in one

continuous transaction continuous transaction

at the same front end screen i.e. Q-Manager can sign after plant manager

SAP AG 2005, , / 26
 - -

PI sheet: accept ECM: status

invalid input values changes of ECOs

ECM: status
PI sheet: complete changes of object
process step management
records

Digital
signature
EBR electronic
PI sheet: event log batch record
approval
Document
management:
status changes

SAP AG 2005, , / 27
 - -

mySAP Healthcare:
material Physical-sample
requisition/Goods drawing
issue

mySAP Public
Sector: digitally Inspection lot:
signing results recording
webrequests

Digital
signature
Learning solution
EBR electronic
300: proof of
batch record
course
approval
participation
Inspection lot:
usage decision

SAP AG 2005, , / 28
 / - "# ! 1 / !2

SAP AG 2005, , / 29
 - #+, 3 - - < -

Transaction
- DSAL

SAP AG 2005, , / 30
 5 9 - -

Easier implementation of e-signature in new processes

Creation of a uniform flexible programming interface. Tool
can be integrated into any business areas either in SAP R/3
or in other systems, such as SAP SCM (APO) or SAP CRM

SAP AG 2005, , / 31
 - -

New: Document
Field

Comment
Field

SAP AG 2005, , / 32
 4 - G

D*E 1 2 D*K
Support Packages: Support Packages:

SAP_ABA SAPKA62023 SAPKH46C26

SAP_APPL SAPKH47008
Generic signature tool is part
of the Enterprise Release.
not available for previous
releases
Kernel 4.6D Patch-Level 1329
Signatures in areas other than
those delivered in 4.6C can be
retrofitted on a project basis using
SAP consulting services.

0 - Customer Enhancements / User Exits

Additional exception handling must be implemented
< $ to synchronize user action with signature.

<
Existing Business Add-ins (BADIs)
Before Save of applications / sign data.
SAP AG 2005, , / 33
 G
9

E-Signatures in mySAP ERP

E-Records in mySAP ERP

SAP AG 2005, , / 34
 I G 3

J * (+ The ability to generate accurate and complete copies of

records in both human readable and electronic form
suitable for inspection, review, and copying by the agency
J *( Use of secure, computer-generated, time-stamped audit
trails to independently record

The user-ID
Date/time stamp of operator entries and actions when the record
was created, modified, or deleted
The transaction type (insert/delete/modify) associated with the
transaction
Record changes shall not obscure previously recorded
information.
New value and old value after record changes
Audit trail documentation shall be retained for a period at least as
long as that required for the subject electronic records and shall be
available for agency review and copying.

SAP AG 2005, , / 35
 The FDA defines an electronic record as any combination of text, graphics, data,
audio, pictorial, or other information representation in digital form that is created,
modified, maintained, archived, retrieved, or distributed by a computer system.

Applying this comprehensive definition to SAP R/3, there are various types of
electronic records, such as:

Configuration within the Implementation Guide (IMG)

Transports and business configuration sets used to

migrate configuration from one system to another
} Change Control

Master data such as the material master, vendor, resource, recipe, and
customer

Business processing objects such as purchase orders, process orders, and

inspection lots

Business process or transaction execution electronic records such as material

documents
Electronic or digital signatures

SAP AG 2005, , / 36
 / +

Release 4.6C Release 4.7

Digital Signature Log Delivered SAP objects Any SAP objects invoked
only using Signature Tool

Change Master Record Changes made to master Changes made to master

(Engineering Change data using ECM data using ECM
Management)

Change Document Object Specific change document Specific change document

Log objects objects

Table Logging Available as a download- Incorporated and available

(Audit Trail Tool) able component for to all
Pharmaceutical customers

SAP AG 2005, , / 37
 / "< 6 #+, 5

Master Data
- Material Master
- Substance Master
- Dangerous Goods
Task Lists
- Routings BOM
- Master Recipes - Material
- Inspection Plan - Equipment
- Equipment Task List - Sales Order
- General Maintenance - Functional Location
- Ref. Rate Routings - Document Structure
- Ref.Operation Set

Documents
Classification System - SOPs
- Classes - MSDS (SafetySheet)
- Characteristics Variant Configuration
- Configuration Profile
- Object Dependencies
SAP AG 2005, , / 38
 FC

SAP R/3 provides complete audit trail for all GMP-relevant e-records, with
User ID
Object ID
Time stamp (system time + time zone)
Transaction code
Old value
User ID
New value Object ID
Date/time
Transaction
Document
Standard technical features include Change Pos. Material Quantity

Change Master Record 10 80000311 1100.0

20 80000620 100.2
Change Document Objects 30 80000636 110.3
User ID 40 80000639 50.0
Table Logging Object ID 50 80000711 10
Date/time
Transaction
1) 20 80000620 100.2
2) old value = 100.2
new value = 99.1

SAP AG 2005, , / 39
 G
Set flag log data changes
in technical settings of table
Must be activated for the
client through system
parameter rec/client
SAP AG 2005, , / 40
Change document objects
must be available for the
transaction
Set flag change document in
technical settings of data
elements
Change document objects
must be embedded in
application
 - / FC

Configuration tool for Audit Trails

Activate additional fields for audit trail completion (activation of
change documents for data elements)
Activate tables for audit trail creation for R/3 transactions where
change documents are not available (table logging)
Selection by
Transaction
Table
CDO
Data element

SAP R/3 4.6c: modification-free add-on

mySAP ERP: included as part of standard

SAP AG 2005, , / 41
 Transactions of 21 CFR Part 11 Enhancement

AUT01: Configuration of Table Logs and Change Documents

AUT02: Configuration of own Assignments

AUT03: Configuration Display Transaction of AUT01

AUT04: Configuration of Longtext Logs

AUT05: Deletion of non-GMP critical Longtext Logs

AUT06: Configuration of View Logging (4.6c only)

AUT10: Reporting of AuditTrails

SAP AG 2005, , / 42
 / - 1 ) ( 2

SAP AG 2005, , / 43
 / " -
3 ) (

SAP AG 2005, , / 44
 3 -1 ) (2

SAP AG 2005, , / 45
 3 -1 ) (2

SAP AG 2005, , / 46
 #+, $

Transaction - C261

SAP AG 2005, , / 47
 < - H

Evaluation of long texts

The user has the option of enhancing data for certain applications by
entering additional comments or explanations, known as long texts
(for example, comments for quality notifications, creation of
batches)

SAP AG 2005, , / 48
 3 $ - < - H 3

Longtexts Archiving object Archive

Archive
Longtext Informations
System

SAP AG 2005, , / 49
 A /

Possibility to activate additional tables for AuditTrail (Table-

Logging)

Possibility to activate additional data elements for AuditTrail (Data

element logging)

Activation of view logging

Flexible, without modification

Support of Support Package-Implementation and R/3-Release

Upgrades

SAP AG 2005, , / 50
 FDA Compliance and Trends

Requirements of 21 CFR Part 11 and

Realization in mySAP ERP

SAP AG 2005, , / 51
 8

Validation Service Map

Audit Trail Management Consulting Solution

Business Configuration Sets

SAP Solution Manager

SAP AG 2005, , / 52
 8 $ 5 ((D

User Requirements
Design Qualification Risk Assessment Validation Master Plan Vendor Audit DQ-Documentation
Specification (URS)

Installation
IQ Protocol IQ System IQ Report
Qualification

Operational Configuration/ Unit and Integration

Solution Specification Training OQ Documentation
Qualification Customizing Testing

Performance
Change Control Program System Acceptance Testing PQ Documentation
Qualification

Installation Qualification
IQ Protocol

Solution Manager (V12, V131, V132, V130, V10)

IT Infrastructure Installation and Integration (V10,
V130, B02, B02, V24, V31)

SAP AG 2005, , / 53
 $ < 3 8/5
8
Audit
management

Validation Change
SOP
Management Release
Master Plan
Best Practices Tools
SOP
Solution
Acceptance
Manager User
Requirements
Test Work Bench
Test PQ
Computer Aided
Test Tool (CATT)
Integration
Specification Test OQ

Business Benefits Design

Cross
Function-
Test MIT
System Viewer
Reduction of
cost of validation Transport
System

Transports
IQ

BC Sets Configuration
Customizing

SAP AG 2005, , / 54
 8

Validation Service Map

Audit Trail Management Consulting Solution

Business Configuration Sets

SAP Solution Manager

SAP AG 2005, , / 55
 4

Consulting Solution = Solution

package for a fixed price

Pre-configured Audit-Trail
Solution
Based on SAP Standard
Functionality (Audit Trail Tool)
Standard-Content
System configuration (BC-Sets
to apply customizing settings
automatically)
Documentation

SAP AG 2005, , / 56
 Scope

List of table fields, data elements..., that require logging

Per application

Risk Assessment (Excel-File)

BC-Set for pre-configuration of Table Logging

Per application
Settings have to be activated manually !

BC-Set for Mapping of Transaction Code against database

table

BC-Set for long-text logging

SAP AG 2005, , / 57
 Scope

Config Docu, Authorization-Docu

User-Manual

Job-Manual

Sample Test Case

Cookbook Reporting of Audit Trail by object

ABAP Program to identify customer-specific database

objects

SAP AG 2005, , / 58
 8

Validation Service Map

Audit Trail Management Consulting Solution

Business Configuration Sets

SAP Solution Manager

SAP AG 2005, , / 59
 A - 3

A Business Configuration Set is a set of

Customizing settings:
Grouped according to logical, business management
criteria
For documentary, quality assurance, and re-use
purposes
Independent of the original Customizing tables/views
Accessible across the system landscape

A "
A
9 - -

$ +
D*K

SAP AG 2005, , / 60
 A 8

To assure FDA compliance, changes in customizing have to be

recorded and documented precisely

Case Study GlaxoSmithKline

Validation of customizing was delivered by paperwork, i.e.
screenshots of customizing were incorporated into a MS Word file
and documented.
Individual documents of that type could comprise up to several
hundreds of pages
New procedure was established in close co-operation with SLM
development
Software modification SAP
Complete traceability of customizing changes throughout the system
landscape
Compare function in the BC Set transaction allows you to compare
already archived BC Sets with customizing tables to identify changes

SAP AG 2005, , / 61
 8

Validation Service Map

Audit Trail Management Consulting Solution

Business Configuration Sets

SAP Solution Manager

SAP AG 2005, , / 62
 5 - 38 6

< + -!

Project Business Realization Final Go Live

Preparation Blueprint preparation & Support

!
5 - #

Functional Implementation Services for Operations

Technical Implementation Solution Monitoring

Implementation of
Operations Support Desk

SAP AG 2005, , / 63
 5 - # -

Test Organizer Landscape Reporting

Analysis of relationship between
Test your configuration alongside
processes and systems
processes

Customizing Synchronization Support Desk

Keep your Customizing settings in Your way to efficient message handling
synch across components

Solution Monitoring
Implementation Platform Continuously watch your business
Implementation support from project processes and system landscapes
administration to configuration
Service Level Reporting
Cross-system reporting and
Implementation Content recommendations beyond EarlyWatch
Accelerate your project with predefined
solution content
Services
Automatic and Self-Services to support
Roadmaps operations
Benefit from methodological guidlines
provided by Implementation, Global or
Solution Management Roadmaps Best Practice Documents
SAPs expert knowledge at your finger
4 tips

Service Delivery SAP Notes

Access all services and support Request professional SAP Support on
offerings during all stages of the demand
solution life-cycle

SAP AG 2005, , / 64
 , 5
Validation
L Summary Report
PQ Production
Validation Project Progress

Verify Production Cutover

OQ Report
OQ Tests
#L Configuration Documentation (BC-Sets)
Test Plan
Test Case Definition
Solution Specification
OQ Protocol
ER/ES Assessment Relevant SOPs in place

L Risk Assessment (Processes)

User Requirements Specification IQ Report
DQ Protocol IQ Prd System
Vendor Audit IQ QA System
IQ Dev System
Validation Master Plan
IQ Protocol
!L
Risk Assessment (System) Technical Specification
Change Control

Project Business Realization Final Go Live

Preparation Blueprint preparation & Support

ASAP Project Progress

SAP AG 2005, , / 65
 8 5 -

SAP AG 2005, , / 66
 8 5 -

SAP AG 2005, , / 67
 8 5 -

SAP AG 2005, , / 68
 8 6 5 -

5 -
Standard product for implementation
Project management / project
administration
Integrated Knowledge Warehouse
Support in operation

8
Integration of validation content into
ASAP methodology
Validation Roadmap
Documents, examples and templates for
validation

SAP AG 2005, , / 69
 A 5 - 8 6

A
Central platform for all implementation
activities
Validation Roadmap
Content for implementation
Central administration for documents, tasks
and results
Process oriented Blueprint-, Configuration-
and Test Approach
Integrated document- and object
administration
Versioning, status tracking and monitpring

SAP AG 2005, , / 70
 5

Solution Manager as Validation Framework

susan.glaess@sap.com
General infos for Solution Manager
http://help.sap.com/ Solution Manager
Best Practices for mySAP Pharmaceuticals
http://help.sap.com/ Best Practices
deniz.oezbilen@sap.com

SAP AG 2005, , / 71
 SAPs robust capabilities can satisfy
the Life Sciences industry
requirements as well as meet individual
customer cGMP needs

SAPs signature tool is versatile and

can be used across SAP's solutions

Enable customers to leverage the SAP

signature tool available in R/3
Enterprise

SAP AG 2005, , / 72
 6 .

L
 - ((@ 4* - $

No part of this publication may be reproduced or transmitted in any form or for any purpose without the express
permission of SAP AG. The information contained herein may be changed without prior notice.
Some software products marketed by SAP AG and its distributors contain proprietary software components of other
software vendors.
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companies.

SAP AG 2005, , / 74