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Table of Contents
1. Introduction........................................................................................................................ 5
1.1 Reference Documents............................................................................................. 5
1.2 Definitions & Acronyms...........................................................................................5
2. Document Purpose.......................................................................................................... 6
3. Short Functional Description.......................................................................................... 6
3.1 GxP Criticality Analysis........................................................................................... 6
3.2 System GAP Analysis..............................................................................................7
4. Business Process Flow Chart........................................................................................ 7
5. Solution............................................................................................................................ 8
5.1 Inventory and Warehouse Management (INV).......................................................8
5.2 Manufacturing (MFG).............................................................................................11
5.2.1 Master Data.......................................................................................................... 11
5.2.2 Production Execution......................................................................................... 22
5.3 Quality Management (QUA)...................................................................................25
5.4 Plant Maintenance (PM)......................................................................................... 38
5.5 Purchasing (PUR)................................................................................................... 45
5.5.1 Master Data......................................................................................................... 45
5.5.2 Purchasing Process........................................................................................... 46
5.6 Standard SAP default configuration.....................................................................48
6. Overview Of SAP Transactions....................................................................................60
6.1 SAP Transactions................................................................................................... 60
6.2 Customizing Activities........................................................................................... 64
7. Overview of Additional Developments.........................................................................81
7.1 Reports, Forms....................................................................................................... 81
7.2 Interfaces................................................................................................................ 81
7.3 Conversions........................................................................................................... 81
7.4 Enhancements.......................................................................................................... 81
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1. INTRODUCTION
Reference Document
Term/Acro Definition/Explanation
nyms
BoM Bill of Material; it is a complete, formally structured list of the components that make up a
product or assembly. The list contains the material number of each component, together with the
quantity and unit of measure.
QA Quality Assurance
PV Production Version; a production version determines which alternative BOM is used together with
which task list/master recipe to produce a material or create a master production schedule.
MFG Manufacturing
PUR Purchasing
GAP GAP is the difference between the available functionalities against functionalities required. A
comparison of the information gathered in the Requirements gathering phase of a project may
identify gaps in the functionalities required compared to the functionalities available. The
Functional Specification Document describes the solution to cover the User Requirements/Gaps
referenced
MAN Manual
FS Functional Specification
GDL Guideline
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2. DOCUMENT PURPOSE
Scope of the document is to provide details about the activation of audit trail functionality on
the system for specific GxP objects and related information. The GxP fields and the
corresponding audit trail reporting are grouped in different areas for the main business areas
impacted by GxP critical data management:
Manufacturing (MFG);
Purchasing (PUR).
For each area, for all GxP critical fields, the transaction requested for reporting all changes is
described.
all the functional specification in scope of Plant Execution work-stream have been
analyzed; for each line the transaction mentioned has been primary classified as GxP
critical when the URS requirement is GxP critical.
After this first screening, a list of all GxP critical transactions has been identified. Within
this list only transaction that could create, change or delete (flag for deletion) objects
have been considered. ‘Display’ transactions, even when classified as GxP critical because
linked with GxP critical requirements, have not been considered as relevant for audit trail
purpose because no changes can be made on the data.
all transactions classified as GxP critical and relevant for audit trail, have been than
analyzed in details: all fields that are somehow requested to be changed during a process
described in a functional specification, where judged as GxP critical or not. In a second
step, fields that are Gxp critical have been analyzed: only if they are modifiable by
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custom or standard transaction, they have been included in standard audit trail
functionality. Final result of this analysis is the list of all the fields that need to be audit
trailed.
The basic goal reached with this analysis is to guarantee that the access to GxP critical fields
is only allowed to user with GxP critical roles and to guarantee that all changes on GxP critical
fields are logged properly.
NOTE
For goods movement transactions, in this analysis an assumption is made. Goods movement
transactions create material documents in Unity, and once a goods movement is created only
few fields are then modifiable (at header level only ‘Document header text’, at item level only
‘Uploading point’ and ‘Text’). The assumption is that the material document that corresponds
to the goods movement that was processed would provide the documentation required for
audit traceability of the goods movement transactions. Subsequent changes on the material
document are traced with the proper transaction for changing material document.
for fields with audit trail activated, the completeness of the current functionality is
checked (for details about all SAP default audit trail activated fields refers to chapter
5.6);
for fields without audit trail an implementation activity is performed and audit trail is
activated (for details about those SAP not default audit trail activated fields refers to
chapters 5.1, 5.2, 5.3, 5.4, 5.5).
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5. SOLUTION
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UNITY-FSP- Batch Search Records for Inventory movement AUT10 001 N/A MFG07-01_0060
MFG-06-0010
The conditions are maintained by transaction MBC1 (Create batch search strategy) MBC1
and MBC2 (Change batch search strategy).
MBC2
Changes on Batch search strategy can be viewed by Pharma Pack tool by
transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the inserted records (each
time a condition has been changed a new record is generated in KONDH table – SAP
table containing all changes performed on a specific table under audit trail table log).
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By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
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PKHD-LGPLA Storage bin
PKHD-NKDYN Indicator: dynamic destination bin
PKHD-BERKZ Material staging indicator for production supply
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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UNITY-FSP- Material Master MM01 004 N/A MFG07-01_0010 X X X X
MFG-06-0040 The material master is maintained by transaction MM01 (Material Master Create) and MM02
MM01, MM03, MM02 (Material Master Change)
Changes on Material Master can be viewed by: AUT10
A. By change document in Transaction MM01, MM02, MM03:
Material number
Select the view
Go in menu to -> Environment -> Display changes
All change documents are listed and double clicking on the change document it is
possible to see list of the fields that have been changed.
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
C. By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
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MARC-VERKZ Version indicator
MARC-FRTME Production unit
MARC-QMATV Inspection Setup Exists for Material/Plant
MARC-QMATA Material Authorization Group for Activities in QM
MARC-KZECH Determination of batch entry in the production/process order
MARA-MEINS Base unit of measure
MARA-RAUBE Storage conditions
MARA-TEMPB Temperature conditions indicator
MARA-TRAGR Transportation group
MARA-MHDHB Total shelf life
MARA-MHDLP Storage percentage
MARA-IPRKZ Period indicator for shelf life expiration date
MARA-RDMHD Rounding rule for calculation of SLED
MARM-MEINH Alternative unit of measure for stock keeping
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “MATERIAL” (SAP
object containing detailed changes to material master).
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Go in menu to -> Environment -> Changes Document
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
Date
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Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
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CRHD-STEUS: Control key
PLKO-AENNR: Change number
PLKO-BMSCH: Base quantity
PLKO-KTEXT: Master recipe description
PLKO-LOSBS: Charge quantity (to)
PLKO-LOSVN: Charge quantity (from)
PLKO-MEINH: Unit of measure of base quantity
PLKO-PLNME: Unit of measure of charge quantity
PLKO-STATU: Status
PLKO-UMREN: Conversion factor (operation quantity)
PLKO-UMREZ: Conversion factor (charge quantity)
PLKO-VERWE: Usage
PLMZ- LGORT: Storage location storage resource
PLPO- EHOFFB: Unit for offset to start
PLPO- EHOFFE: Unit for offset to finish
PLPO- OFFSTE: Offset to sub operation finish
PLPO-ARBID: Resource
PLPO-BMSCH: Base quantity
PLPOD-UVORN: Secondary resource allocation number
PLPO-LTXA1: Operation description
PLPO-LTXA1: Description
PLPO-MEINH: Unit of measure for operation
PLPO-MEINH: Unit of measure for operation
PLPO-PHFLG: Phase indicator
PLPO-PHSEQ: Control recipe destination
PLPO-STEUS: Control key
PLPO-UMREN: Conversion factor (Operation quantity)
PLPO-UMREZ: Conversion factor (Charge quantity)
PLPO-VORNR: Operation / phase number
PLPO-VORNR: Phase number
PLPO-WERKS: Plant
RC271- STTAG: Key date (Valid from date)
STPO-IDNRK: BOM component
STPO-IDNRK: Component
STPO-MENGE: Requirement Quantity
STPO-POSNR:BOM component number
STPO-POSTP: Item category
STPO-REKRS: Recursiveness allowed
PLPO-ISTKN BOM Item node Number
PLPO-RUZUS Key rounding and additional values
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Changes on Production Version can be viewed by Pharma Pack tool by transaction
AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
Following fields are considered as critical and changes are logged as explained
below:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The following fields do not need an audit trail because the history of changes can be
retrieved by getting the respective ECM
PLKO-FLG_CHKED Recipe consistency flag
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Process instructions and inspection characteristic changes via C202 can be retrieved
with transaction C261. For more detail, AUT10 can be used for looking at the
changes
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
CRHD-ARBPL Resource
AUSP-ATWRT Characteristic value
P3000-LGORT_RES Storage location storage resource
CRHD-MIXMAT Indicator: mixing of material allowed
CRHD-PLANV Usage
CRHD-PRVBE Supply area
CRHD-RGEKZ Indicator: Back-flushing
CRHD-VERAN Person responsible
CRHD-VGWTS Standard value key
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CRHD-WERKS Plant
CRHD-PAR01: First Work Center Parameter (for formulas)
CRHD-PAR02: Second Work Center Parameter (for formulas)
CRHD-PAR03: Third Work Center Parameter (for formulas)
CRHD-PAR04: Fourth Work Center Parameter (for formulas)
CRHD-PAR05: Fifth Work Center Parameter (for formulas)
CRHD-PAR06: Sixth Work Center Parameter (for formulas)
Changes of the description and other change for the resources can be checked via
transaction CR10.
All changes to resource classification values can be checked (AUSP-ATWRT).
UNITY-FSP- Batch Search Records for Process Order AUT10 009 N/A MFG07-01_0050 X X
MFG-06-0080
The Resource is maintained by transaction COB1 (Creation of batch search record) COB1
and COB2 (Change of batch search record).
COB2
Changes on Resource can be viewed by Pharma Pack tool by transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
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KOTH030-DATBI Validity end date of the condition record
KOTH031-DATBI Validity end date of the condition record
KOTH030-KSCHL Batches: Search strategy type
KOTH031-KSCHL Batches: Search strategy type
KOTH030-MATNR Material number
KOTH031-MATNR Material number
KOTH030-WERKS Plant
KOTH031-WERKS Plant
KONDH-KNUMH Condition record number
KONDH-CHSPL Number of batch splits can be changed
KONDH-CHANZ Batches: Maximum number of batches to be read
KONDH-CHASP Batches: No. of batch splits allowed
KONDH-CHMDG Batches: Dialog batch determination
KONDH-CHMVS Batches: Exit to quantity proposal
KONDH-CHMAN Manual batch determination
KONDH-KZAME ID for display of UoM in batch determination
KONDH-CHDYN Number of the following screen
KONDH-CHCUA GUI status
KONDH-CUOBJ_CH Internal object number of the batch classification
KONDH-CLINT Internal Class Number
KONDH-LOEVM_KO Deletion indicator for condition item
KONDH-CHVSK Selection type at start of batch determination
KONDH-CHVLL Over-delivery allowed in batch determination
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By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “KLASSE”.
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Changed by (optional)
Transaction code (CT04)
By pressing execute the system provides the Output of table logs. For each table log
(by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “FEATURE”.
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PRODUCTION EXECUTION
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UNITY-FSP- Process order AUT10 012 N/A MFG07-01_0110 X X
MFG-06-0110
The Process order is created by transaction COR1, CORO, COR8 and it is COR1
maintained by transaction COR2 (Process order change).
COR2
Changes in the process order are obtained by the transaction for confirmation
(COR6, COR7, CORM). CORO
Changes on Process Order can be viewed by Pharma Pack tool by transaction
AUT10: COR6
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter: COR7
Start date (mandatory) COR8
Start time (mandatory)
End date (mandatory) CORM
End time (mandatory) CO44
Changed by (optional)
CORR
Transaction code (COR1, COR2, CORO, COR6, COR7, COR8, CORM, CO44); for
CORS
massive changes the transaction CO44 must be used as selection parameter.
CORT
By pressing execute the system provides the Output of Change documents and
table logs.
Table log has been deactivated (where possible) for following table:
RESB
AFFL
AFPO
AUFK
RSADD
For these tables an enhancement has been implemented, driven by the OSS note
390635 that creates change documents for the changes performed in a process
order. This enhancement has been created for the following reason:
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Enhancement defines additional logic to decide whether change documents are
created.
For each change document (by row selecting) it is possible to have the details for
the following fields
Table-Field Description
AFKO-AENNR Change number
AFKO-AENNR Change number
AFKO-AENNR Change number
AFVC-AENNR Change number
AFFL-AENNR Change number
AUFK-AUART Order type
AUFK-IDAT2 Technical completion date
AFPO-XLOEK Deletion flag
AFKO-BMENGE Base quantity
AFVV-BMSCH Base quantity
AFKO-AUFLD Date of BOM explosion/routing transfer
AFKO-SFCPF Production scheduling profile
AFPO-PSMNG Order item quantity
AFKO-GAMNG Total order quantity
AFKO-GASMG Total scrap quantity in the order
AFVV-GMNGA Confirmed yield in order unit of measure
AFVC-SPLIM Maximum number of splits
AFVC-SPANZ Actual number of splits
AFVC-SPMUS Required splitting
AFKO-STLAL Alternative BOM
AFKO-STLAN BOM usage
AFVC-ISTKN BOM item node number
AFKO-STLST BOM status
AFKO-STLTY BOM category
AFVC-ISTTY BOM category
AFKO-STLNR Bill of material
AFVC-ISTNR Bill of material
AFPO-UNTTO Under-delivery tolerance limit
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AFPO-VERID Production version
AFKO-ARSPS Order Item Number
AUFK-PHAS0 Phase “Order created”
AUFK-PHAS1 Phase “Order released”
AUFK-PHAS2 Phase “Order completed”
AUFK-PHAS3 Phase “Order Closed”
The order confirmation doesn’t involved any GMP critical field so the Audit trail is
not required.
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UNITY-FSP- Batch Master – Basic Data AUT10 013 N/A MFG07-01_0120 X X X X X
MFG-06-0120
The batch master is maintained by transaction MSC1N (Batch Master Create) and MSC2N 014
MSC2N (Batch Master Change). The batch master can be created or changed by
different other transactions (MSC2N, MIGO, MB11, MB1B, MB1C, MB31, MIGO
MIGO_GO, QA11, QA12, SE38)
MB11
Changes on Batch Master Basic Data can be viewed by: MB1B
A. By change document in Transaction MSC2N or MSC3N:
Material number MB1C
Plant MB31
Batch ID
Go to tab “Change” QA11
All change documents are listed and double clicking on the change document it is
possible to see list of the fields that have been changed. QA12
SE38
B. By Pharma Pack Tool by transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
Transaction code (MSC2N, MIGO, MB11, MB1B, MB1C, MB31, MIGO_GO, QA11,
QA12, SE38)
By pressing execute the system is provide the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
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MCHA-VFDAT Shelf Life Expiration Date
MCHA-ZUSTD Batch in restricted-use stock
MCHA-ZAEDT Date of last status change
MCHA-LIFNR Vendor's account number
MCHA-LICHA Vendor batch number
MCHA-VLCHA Original batch number (deactivated)
MCHA-BWTAR Valuation type
MCHA-CHAME Unit of issue for batch (deactivated)
MCHA-LWEDT Date of last goods receipt
MCHA-FVDT1 Date for unrestricted use
MCHA-FVDT2 Date for unrestricted use
MCHA-FVDT3 Date for unrestricted use
MCHA-FVDT4 Date for unrestricted use
MCHA-FVDT5 Date for unrestricted use
MCHA-FVDT6 Date for unrestricted use
MCHA-HERKL Country of origin of the material
MCHA-HERKR Region of origin of material (non-preferential origin)
MCHA-MTVER Export/import material group
MCHA-QNDAT Next Inspection Date
MCHA-HSDAT Date of production of the batch
MCHA-CUOBJ_BM Internal object no.: Batch classification
MCHA-ZUSCH: Batch Status Key
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “CHARGE”.
Batch Master long text audit trail can be displayed by Pharma Pack Tool by
transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: advanced mode’ (click on the
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icon ‘Standard – advanced’) and enter:
Transaction code (MSC2N, MIGO, MB11, MB1B, MB1C, MB31, MIGO_GO, QA11,
QA12, SE38)
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End time (mandatory)
Changed by (optional)
Transaction code (MSC2N, MIGO, MB11, MB1B, MB1C, MB31,
MIGO_GO, QA11, QA12, SE38)
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “CLASSIFY”.
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By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “QPRUEFLOS”.
Inspection lot long text audit trail can be displayed by Pharma Pack Tool by
transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: advanced mode’ (click on the
icon ‘Standard – advanced’) and enter:
Text object (optional), for this long text insert “QPRUEFLOS” (long text code)
Text ID (optional), for this long text insert “QALS” (long text code)
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By pressing execute the system provides the Output of table logs.
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
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QAVE-QKENNZAHL Quality Score
QAVE-LTEXTKZ LONG TEXT FOR USAGE DECISION
QAVE-KZART INSPECTION LOT, PARTIAL LOT, SINGLE UNIT,
INTERVAL
QAVE-ZAEHLER COUNTER FOR USAGE DECISION
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “QPRUEFLOS”.
Usage Decision long text audit trail can be displayed by Pharma Pack Tool by
transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: advanced mode’ (click on the
icon ‘Standard – advanced’) and enter:
UNITY-FSP- Quality Inspection – Sample Drawing Procedure QPV2 020 N/A MFG07-01_0160 X X X
MFG-06-0160
AUT10
The sample drawing procedure can be created and modified with transaction
QPV2 (which is calling transaction SM34 in the background).
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Changes on the Sample Drawing Procedure can be displayed with Pharma Pack
Tool by transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
By pressing execute the system provides the Output of change documents logs
(object QPRV). For each record (by row selecting) it is possible to have the details
for the following fields:
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Stage
QPRVP-FAKTORPR1 Factor for Determining the Sample Size of a
Primary Sample
QPRVP-FORMEL1 Formula Field for the Number of Samples
QPRVP-GEBINDER Physical-Sample Container for Reserve Sample
QPRVP-ANZRUECKL Number of Reserve Samples
QPRVP-UMFRUECKL Size of Reserve Sample
QPRVP-MERUECKL Unit of Measure for Reserve Sample
QPRVP-GEBINDE2 Physical-Sample Container for Drawing Pooled
Sample
QPRVP-STPRPLAN2 Sampling Scheme for Pooled Sample Stage of
Sample Drawing
QPRVP-PRSCHAERF2 Insp. Severity of Sampling Procedure. At Pooled
Sample Stage
QPRVP-AQLWERT2 AQL Value in Pooled Sample Stage
QPRVP-PRANZ2 Fixed No. of Physical Samples for Pooled Sample Stage
QPRVP-FAKTORPR2 Factor for Determining the Sample Size of a Pooled
Sample
QPRVP-FORMEL2 Formula Field for the Number of Samples
QPRVP-ERSTELLER Name of User Who Created the Data Record
QPRVP-AENDERER Name of User who Most Recently Changed the Data
Record
QPRVP-DATUMERST Date on Which the Data Record Was Created
QPRVP-ZEITERST Time Data Record Was Created
QPRVP-DATUMAEND Date on Which Data Record Was Changed
QPRVP-ZEITAEND Time of Last Data Record Change
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
The audit trails are recorded under the change document object “QPRV”.
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UNITY-FSP- Quality Inspection – Inspection Method QS31 020 N/A MFG07-01_0170
MFG-06-0170
The inspection method can be created and modified with transaction QS31 AUT10
Changes on the inspection method can be displayed with Pharma Pack Tool by
transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
UNITY-FSP- Selected sets for Master Inspection Characteristics AUT10 021 N/A MFG07-01_0200 X X X
MFG-06-0180 The Selected sets is maintained by transaction QS51 (Edit selected set)
QS51
Changes on Sampling Procedure can be viewed by Pharma Pack Tool by
transaction AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
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Changed by (optional)
Transaction code QS51
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
QPAM-KTX01(short description)
QPAC-CODEGRUPPE (code group)
QPAC-CODE (code)
QPAC-BEWERTUNG (valuation)
QPAC-FEHLKLASSE (defect class)
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
UNITY-FSP- Quality Inspection – Master Inspection Characteristics QS31 N/A N/A MFG07-01_0190
MFG-06-0190
The Master Inspection Characteristics are maintained by transaction QS31 (Create QS32
Master Inspection Characteristic) and QS32, QS33, (Change Master Inspection
Characteristic). X X X
Changes on Master Inspection Characteristics are shown by SAP using the Field
history button in QS32/QS33.
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Start date (mandatory)
Start time (mandatory)
End date (mandatory)
End time (mandatory)
Changed by (optional)
Transaction code (QP01 for inspection plan creation and QP02 for inspection plan
changing)
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
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Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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UNITY-FSP- Maintenance Plan AUT10 023 N/A MFG07-01_0220 X
MFG-06-0210
The Maintenance Plan is maintained by transaction IP01 and IP02. IP01
Changes on Maintenance can be viewed by Pharma Pack Tool by transaction
IP02
AUT10:
Start transaction AUT10 ‘Evaluation of audit trail: standard mode’ and enter:
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields
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MPLA-CALL_CONFIRM: Only Create New Call Object After Completing
Predecessor
MPLA-STRAT: Maintenance Plan Strategy
MPLA-PLAN_SORT: Sort field for maintenance plans
MPLA-BEGRU: Technical object authorization group
MPLA-TPLNR: Functional Location
MPLA-EQUNR: Equipment Number
MPOS-PLNTY: Task List Type
MPOS-PLNNR: Key for Task List Group
MPOS-PLNAL: Group Counter
MPLA-START_DATE: Start Date for Scheduling
MPLA-START_TIME: Start Time for Scheduling
ITOBATTR-SERUNI: Serial Number
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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By pressing execute the system is provided the Output of table logs. For each
table log (by row selecting) it is possible to have the details for the following
fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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By pressing execute the system is provided the Output of table logs. For each
table log (by row selecting) it is possible to have the details for the following
fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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Changed by (optional)
Transaction code (IP10)
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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Transaction code (IP30)
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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End time (mandatory)
Changed by (optional)
Transaction code (IE01 for equipment creation and IE02 for
equipment changing)
By pressing execute the system provides the Output of table logs. For each table
log (by row selecting) it is possible to have the details for the following fields:
Date
Time
Changed by
Transaction Code
Name of transaction
Table and field changed
Old value
New value
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UNITY-FSP- Vendor Master AUT10 N/A N/A MFG07-01_0260 X X X X
MFG-06-0260
The vendor master is together with material master, one of the master data MK03
needed in purchasing area.
SE16
Changes on Vendor master can be viewed by:
Transaction MK03 (select all the views for General and Purchasing organization
data)
Go to menu to -> Environment -> Field changes
All changes are displayed for General and Purchasing organization data
SE16 Table CDHDR:
Change doc. object = KRED, KRED_N
Object value = 10 character vendor number (leading zero’s required!)
(Document number)
SE16 Table CDPOS:
Change doc. object = KRED, KRED_N
Object value = 10 character vendor number (leading zero’s required!)
(Document number)
The following fields are used for the determination of the vendor as unique and
the changes to these fields are logged as explained below:
Purchasing data:
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LFM1-SPERM: Purchasing block at purchasing organization level
LFM1-LOEVM: Delete flag for vendor at purchasing level
Partner Data:
WYT3-DEFPA: vendor partner functions
PURCHASING PROCESS
Line No. Description of solution with Business process step number T.Code Cust. No Dev. No URS Reference
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UNITY-FSP- Purchase Order AUT10 N/A N/A MFG07-01_0270 X X X X
MFG-06-0270
Changes on Purchase Order can be viewed by: ME23N
Transaction ME23N:
SE16
Select the PO document number
SE16 Table CDHDR:
Object Class= EINKBELEG
Object id= PO Document number
Changer = 10 digit change number
SE16 Table CDPOS:
Object Class= EINKBELEG
Object id= PO Document number
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Changenr = 10 digit change number
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UNITY-FSP- Change Objects for Audit Trail are already defaulted for other GxP critical fields in N/A N/A N/A MFG07-01_0010
MFG-06-0280 SAP and don’t need any further customization in the system. MFG07-01_0020
In the table below the objects are listed. MFG07-01_0030
MFG07-01_0040
MFG07-01_0050
MFG07-01_0060
MFG07-01_0070
MFG07-01_0080
MFG07-01_0090
MFG07-01_0100
MFG07-01_0110
MFG07-01_0120
MFG07-01_0130
MFG07-01_0140 X X X X X
MFG07-01_0150
MFG07-01_0160
MFG07-01_0170
MFG07-01_0180
MFG07-01_0190
MFG07-01_0200
MFG07-01_0210
MFG07-01_0220
MFG07-01_0230
MFG07-01_0240
MFG07-01_0250
MFG07-01_0260
MFG07-01_0270
Business object
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CT04 Characteristics
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001 Customizing setting for Batch Search strategy for inventory movement Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the table KONDH AUT02
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
MBC1 KONDH
MBC2 KONDH
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
LU02 LUBU
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
LPK2 PKHD
In transaction AUT02 the following links between transaction and tables will be defined:
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Trans. Table
MM01 MARA
MM02 MARA
MM03 MARA
MM01 MARC
MM02 MARC
MM03 MARC
005 Customizing setting for Material Bom Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o STKO-AENNR Change Number
o STPO-AUSCH Component scrap %
o STKO-DATUV Valid from date
o STPO-FMENG Fixed Quantity
o MAST-MATNR Material Number
o STPO-MEINS Unit of measure
o STPO-REKRS Recursiveness allowed
o MAST-STLAL Alternative BOM
o MAST-STLAN BOM usage
o MAST-WERKS Plant
o MAST_STLNR Bill of Material
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
CS01 MAST
CS01 STKO
CS01 STOP
CS02 MAST
CS02 STKO
CS02 STOP
006 Customizing setting for Recipe and Production Version Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o PLKO-AENNR Change number
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
C201 PLKO
C201 PLPO
C201 STPO
C201 MKAL
C202 PLKO
C202 PLPO
C202 STPO
C202 MKAL
C223 MKAL
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009 Customizing setting for Batch Search strategy for process order Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o KOTH031-CO_MATNR Material number for order
o KOTH031-MANDT Client
o KOTH030-MATNR Material number
o KOTH031-MATNR Material number
o KOTH030-WERKS_D Plant
o KOTH031-WERKS_D Plant
o KONDH-CHSPL Number of batch splits can be changed
o KONDH-CHMDG Batches: Dialog batch determination
o KONDH-CHMVS Batches: Exit to quantity proposal
o KONDH-CHMAN Manual batch determination
o KONDH-CHVLL Overdelivery allowed in batch determination
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
COB1 KOTH031
COB1 KOTH030
COB2 KOTH031
COB2 KOTH030
COB1 KONDH
COB2 KONDH
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Trans. Object
CL01 KLASSE
CL02 KLASSE
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
CT04 CAWN
012 Customizing setting for Process Order Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o AFFL-AENNR Change number
o AFKO-AENNR Change number
o AFKO-AENNR Change number
o AFKO-AENNR Change number
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Trans. Table
COR1 AFVC
CORO AFVC
COR8 AFVC
COR6 AFVC
COR7 AFVC
CORM AFVC
013 Customizing setting for Batch Master Basic Data Audit Trail AUT02
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Object
MSC2N CHARGE
MIGO CHARGE
MB11 CHARGE
MB1B CHARGE
MB1C CHARGE
MB31 CHARGE
MIGO_GO CHARGE
QA11 CHARGE
QA12 CHARGE
014 Customizing setting for Batch Master long text Audit Trail AUT04
In transaction AUT04 the following entry should be deactivated:
Text
object Text ID
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CHARGE VERM
A job is schedule that deletes all the long texts flagged in table TTXID. Current job scheduled run program AUT_DEL.
015 Customizing setting for Batch Master Classification Audit Trail AUT02
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Object
MSC2N CLASSIFY
MIGO CLASSIFY
MB11 CLASSIFY
MB1B CLASSIFY
MB1C CLASSIFY
MB31 CLASSIFY
MIGO_GO CLASSIFY
QA11 CLASSIFY
QA12 CLASSIFY
016 Customizing setting for inspection lot Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o QALS-LMENGEIST Actual Lot Quantity
o QALS-PASTRTERM Inspection Start Date
o QALS-PAENDTERM End Date of the Inspection
o QALS-KTEXTLOS Short Text
o QALS-LTEXTKZBB Log Exists for Usage Decision
o QALS-WAPOS Maintenance Item
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
QA02 QALS
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QA11 QALS
QA12 QALS
017 Customizing setting for Inspection lot long text Audit Trail AUT04
In transaction AUT04 the following entry should be deactivated:
A job is schedule that deletes all the long texts flagged in table TTXID. Current job scheduled run program AUT_DEL.
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
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QA11 QAVE
QA12 QAVE
019 Customizing setting for Inspection lot long text Audit Trail AUT04
In transaction AUT04 the following entry should be deactivated:
Text object Text ID
QPRUEFLOS QAVE
A job is schedule that deletes all the long texts flagged in table TTXID. Current job scheduled run program AUT_DEL.
020 Customizing setting for Quality Inspection – Sample Drawing Procedure Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o QPRVK-GUELTIGAB Valid-from date
o QPRVK-SORTFELD Search Field
o QPRVK-QMASTAUTH Authorization Group QM Basic Data
o QPRVK-GEBANZ Physical-Sample Drawing Based on No. of Containers
o QPRVK-KZQUIT Confirmation Required for Physical-Sample Drawing
o QPRVK-ERSTELLER Name of User Who Created the Data Record
o QPRVK-AENDERER Name of User who Most Recently Changed the Data Record
o QPRVK-DATUMERST Date on Which the Data Record Was Created
o QPRVK-ZEITERST Time Data Record Was Created
o QPRVK-DATUMAEND Date on Which Data Record Was Changed
o QPRVK-ZEITAEND Time of Last Data Record Change
o QPRVK-KZNVPRZV Sample-drawing Procedure Cannot Be Used
o QPRVK-KZVPRZVPL Sample-Drawing Procedure Is Used in Task List
o QPRVP-LOSGEBEH Lot Container
o QPRVP-PROBNRPL Highest Partial Sample No. Valid for Instruction
o QPRVP-GEBINDE1 Physical-Sample Container for Drawing Primary Sample
o QPRVP-STPRPLAN1 Sampling Scheme for Primary Sample Stage of Sample Drawing
o QPRVP-PRSCHAERF1 Insp. Severity in Samp.-Draw. Proc. At Primary Sample Stage
o QPRVP-AQLWERT1 AQL Value in Primary Sample Stage
o QPRVP-PRANZ1 Fixed No. of Physical Samples for Primary Sample Stage
o QPRVP-FAKTORPR1 Factor for Determining the Sample Size of a Primary Sample
o QPRVP-FORMEL1 Formula Field for the Number of Samples
o QPRVP-GEBINDER Physical-Sample Container for Reserve Sample
o QPRVP-ANZRUECKL Number of Reserve Samples
o QPRVP-UMFRUECKL Size of Reserve Sample
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
QPV2 QPRVK
QPV2 QPRVP
021 Customizing setting for Selected sets for Master inspection characteristics Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
o QPAM-KTX01 (short description)
o QPAC-QCODEGRP (code group)
o QPAC-QCODE (code)
o QPAC-BEWERTUNG (valuation)
o QPAC-FEHLKLASSE (defect class)
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
QS51 QPAM
QS51 QPAC
022 Customizing setting for Inspection Plan Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
QP01 PLKO
QP01 PLMK
QP01 PLPO
QP02 PLKO
QP02 PLMK
QP02 PLPO
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
IP01 MPLA
IP02 MPLA
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024 Customizing setting for General Task List Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
IA05 PLKO
IA06 PLKO
IA05 PLPO
IA06 PLPO
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
IW31 AUFK
IW31 AFIH
IW32 AUFK
IW32 AFIH
IW33 AUFK
IW33 AFIH
026 Customizing setting for Schedule Maintenance Plan Audit Trail AUT01
In transaction AUT01 the logging flag will be activated for the following fields: AUT02
In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
IP30 AUFK
IP30 AFIH
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In transaction AUT02 the following links between transaction and tables will be defined:
Trans. Table
IE01 EQUI
IE01 EQKT
IE01 AUSP
IE01 KSSK
IE01 JSTO
IE01 JEST
IE02 EQUI
IE02 EQKT
IE02 AUSP
IE02 KSSK
IE02 JSTO
IE02 JEST
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7.2 INTERFACES
Dev. No FS-I Document Name Description FS Line No.
7.3 CONVERSIONS
Dev. No FS-C Document Name Description FS Line No.
7.4 ENHANCEMENTS
Dev. No FS-R Document Name Description FS Line No.
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