fda 21 cfr part 11 manual v6 en

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Electronic Records

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Release 622



SAP Online Help 02.07.2003

Copyright

© Copyright 2003 SAP AG. All rights reserved.

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Electronic Records 622 2




Icons

Icon Meaning

Caution

Example

Note

Recommendation

Syntax

Typographic Conventions

Type Style Description

Example text Words or characters that appear on the screen. These include fieldnames, screen titles, pushbuttons as well as menu names, paths andoptions.

Cross-references to other documentation.

Example text Emphasized words or phrases in body text, titles of graphics and tables.

EXAMPLE TEXT Names of elements in the system. These include report names,program names, transaction codes, table names, and individual keywords of a programming language, when surrounded by body text, for example, SELECT and INCLUDE.

Example text Screen output. This includes file and directory names and their paths,messages, source code, names of variables and parameters as well asnames of installation, upgrade and database tools.

EXAMPLE TEXT Keys on the keyboard, for example, function keys (such as F2) or the

ENTER key.

Example text Exact user entry. These are words or characters that you enter in thesystem exactly as they appear in the documentation.

<Example text> Variable user entry. Pointed brackets indicate that you replace thesewords and characters with appropriate entries.





Electronic Records .................................................................................................................... 5 Electronic Records................................................................................................................. 6 Electronic Records Functional Overview............................................................................... 8 Authorizations for Electronic Records.................................................................................. 10 Comparison Between Customer System and SAP System ................................................ 11

Aligning System Configuration Status.............................................................................. 12

Changing Table and Data Element Logging........................................................................ 13 Changing Logging Settings.............................................................................................. 15

Assigning Changed Objects to Transactions....................................................................... 18 Assigning a Table to a Transaction.................................................................................. 18

Logging Long Texts ............................................................................................................. 20 Managing Long Texts....................................................................................................... 21

Filter for Long Text Logging ............................................................................................. 25

Evaluating Logged Data....................................................................................................... 26 Entering Selection Conditions.......................................................................................... 30

Carrying Out Evaluations ................................................................................................. 31

Archiving Long Text Logs .................................................................................................... 33 Evaluating Archived Long Texts .......................................................................................... 36





Electronic Records

Background

The US health authority – the Federal Drug Administration (FDA) – requires companies in thepharmaceutical industry that want to introduce their products on to the US market to provide adetailed, complete, and traceable description of their production process. This includes alloperations affecting product quality that are carried out during the process of manufacturingand distributing a drug.

Naturally, the data that is created or processed during these processes is subject to frequentchanges. The FDA requires every change to this data to be documented in a change log. Inthis log, all data changes must be completely traceable at all times. As a result, it mustcontain at least the change date and time, the type of change, the data value before and after the change, and identification of the person who made the change.

This change logging is a key prerequisite that must be met in order to comply with theregulations for Good Manufacturing Practice (GMP) . These GMP regulations are part of the

conditions for “regulated production,” and were drawn up by the FDA to achieve standardizedguidelines for the production of drugs and medicines on the US market. They have sincebecome a “quasi-standard” in many other countries. Adherence to the GMP rules duringproduction of a drug, and, in particular, proof of this adherence, are absolute prerequisites for successful introduction of a product on to the market. Validation of the quality-relevantbusiness processes is a prerequisite for obtaining product approval. This approval is, in turn,a prerequisite for introducing the product on to the US market.

Because of the increasing use of electronic tools, the FDA needed to develop guidelines for the logging of data changes in electronic media. These FDA activities led to the Final Rule 21CFR Part 11 Electronic Records, Electronic Signature. In this rule, the FDA defines howchanges in electronic data records are to be logged, so that these changes are traceable inline with the aforementioned criteria and can be evaluated if necessary taking account of particular factors.

The logging of data that currently takes place in the SAP R/3 System as part of changedocument creation does not satisfy all the FDA requirements. In particular, with the optionscurrently available, it is not possible to evaluate the data to a sufficient extent or with theaccuracy demanded by the FDA. In addition, it is extremely difficult to change the loggingsettings (logging yes or no).

The function Part 11 CFR 21 Enhancement on Electronic Records extends the previouslyavailable options so that logging settings can be changed easily and without technicalmodifications, and that evaluations of the changed data can be carried out in line with FDArequirements.





Electronic Records

Purpose

With the function FDA 21 CFR Part 11 Enhancement on Electronic Records (abbreviated toElectronic Records below), you can:

• Activate and deactivate logging for the required data elements, tables, and long textsspecifically and without technical modifications.

• In the case of corrections or a system update, determine for each object whether youwant to retain the logging settings that currently exist in the system, or make differentlogging settings for the newly imported data.

• With the evaluation function, find and display the changed objects according to certaincriteria, and therefore carry out an evaluation of the changed data conforming to GMP.

Integration

During change document creation and table logging, the SAP R/3 System already logs datachanges. Logging can take place on two levels:

• For individual table fields (data elements) through documentation in change documents

• For whole tables through table logging

Logging in change documents

In order for data changes in table fields to be logged in change documents:

• the transaction in which the content of the table field can be changed must beconnected to change document creation.

• the table containing the table field must exist in the connected change document

object.

• logging must be active for the data element in the relevant change document.

As not all data is relevant for every application, it does not make sense to activatelogging for all data elements from the outset.

For further information on change documents, see the SAP Library, under mySAP

Technology Components → SAP Web Application Server → ABAP Workbench → Extended

Applications Function Library → Change documents.

Table logging

If the transaction that uses the changed data element is not connected to change documentcreation, the system cannot log the change made to an individual table field (data element).Instead it logs the whole changed table. For this to be possible, you must set the systemprofile parameter rec/client to active in every client in which you want to carry out tablelogging.

Only system administrators can activate or deactivate the system profileparameter rec/client .

For further information on logging tables, see the SAP Library under mySAP Technology

Components → SAP Web Application Server → Customizing → Customizing SystemSettings.





In the SAP R/3 System, a lot of transactions, but by no means all of them, are connected tochange document creation. For performance and memory reasons, it does not make sense tolog every data change. You should only log those that need to be included in subsequentevaluations. It must be possible to specifically change logging of data elements/tables.





Electronic Records Functional Overview

Use

With 21 CFR Part 11 Enhancement on Electronic Records (referred to below only asElectronic Records ) you can change or display the logging settings of individual table fieldsand whole tables (that is, activate or deactivate logging).

Prerequisites

You must have the authorization to display, change and evaluate the changed data (see:Authorizations for Electronic Records [Page 9]).

It must be possible to transport the objects (tables and data elements ) that you want tochange the logging settings for. Therefore, local objects cannot be changed.

To change the logging setting for individual table fields, the related transaction must beconnected to change document creation. If it is not, only the table as a whole can be logged.

The system defines whether a transaction is connected to change documentcreation.

Using the system profile parameter rec/client , you define which clients table logging is activein.

Features

Electronic Records consists of several sub-functions that can be made available individuallyaccording to user authorizations:

Transaction Use

AUT01 Comparison and adjustment of old and new logging settings after a systemupgrade (takes place automatically). Also displays manual changes to thesetting in other transactions if these were previously configured withtransaction AUT01.

AUT01 Change to logging settings for individual table fields or whole tables. Thesystem stores every change to the logging settings so that the previous statuscan be restored after a system upgrade.

AUT02 Creation of graphical navigation aid so that changed objects can be locatedagain quickly. As an alternative to this, transaction AUT01 contains direct

technical access for experienced users. If you are activating or deactivatinglogging for an object for the first time, you must always use the technicalaccess.

AUT03 Display of logging settings for table fields or tables. If you are not authorized tochange the logging settings, you can display them with this transaction.

AUT04 Setting for deleting long text logs.

AUT05 Immediate deletion of long text logs from the logging table.

AUT10 Evaluation of logged data according to individually determined criteria.





Although it is also possible to change the logging settings for tables and dataelements by modifying the SAP System, SAP recommends that you use only theElectronic Records function to change logging settings. This is the only way toensure complete and uniquely traceable change documentation.

Changes to the logging setting are carried out without technical modificationsbeing made to the system. This does not mean that the changes do not have aneffect on the business and technical processes of the SAP standard system. If you change logging settings, you have to carry out a thorough test of thebusiness processes you implemented and use in the SAP System.

The system stores every change to table or data element logging so that the current loggingstatus can be restored after an upgrade or correction (see: Comparison Between Customer System and SAP System [Page 11]).

Constraints

• Electronic Records does not create new change document objects nor does it extendexisting ones.

• The evaluation function does not take account of archived data (for example, on opticaldata storage media).

• In an evaluation, it is not possible to determine which changes the user made andwhich resulting changes were automatically made by the system.

• Table logging is only able to record tables that are not bigger than the logging tableitself. In the current release, the logging table is 16,000 bytes, and is therefore largeenough for long text logging.

• In rare cases, if the structure of a table is significantly different after Release 4.5B,

errors may occur during evaluation. It is possible that the changed data is not evaluatedcorrectly, especially if comparisons between the only and new structure are beingcarried out.

• The logging settings for some central Basis tables cannot be changed.





Authorizations for Electronic Records You need the following authorizations to be able to use the Electronic Records functions:

Authorization objectsTransaction

S_TCODE S_TABU_DIS S_DEVELOP S_PROGRAMM

AUT01

(activate directly)

AUT01 Authorization

group AUT

OBJTYPE: DTEL, TABT

ACTVT: 02, 07

-

OBJTYPE: DTEL, TABT

ACTVT: 02

-AUT01

(mass activation)

AUT01 Authorization

group AUT

OBJTYPE PROG

ACTVT: 03

OBJNAME: RADMASG0_C3

DEVCLASS: SDTB

ACTVT: SUBMIT

AUT03 AUT03 Authorization

group AUT

OBJTYPE: DTEL, TABT

ACTVT: 03

-

AUT04 AUT04 Authorization

group AUT

OBJTYPE: TABT

(for packet STDX, objectsSTXL, STXH)

-

AUT05 and reportAUT_DEL

AUT05 Authorization

group AUT

- -

AUT10 AUT10 - - -

To be able to use transaction AUT10, authorization object C_AUT_TCD must also containentries for the transactions that you want to evaluate with AUT10. Contact your systemadministrator to obtain these authorizations.

You can only execute transactions AUT01 and AUT04 in change mode if thesystem profile parameter rec/client is active for at least one client/the currentclient.

For archiving, you need the same authorizations as for transaction AUT05.

For the evaluation of archived long texts in the Archive Explorer, you need the sameauthorizations as for transaction AUT10.





Comparison Between Customer System and SAPSystem

Use

With this function, the system compares the logging setting (logging yes or no) in the SAPSystem and customer-specific system for tables, data elements and long texts. It runsautomatically every time the Change configuration of logging (AUT01) transaction is started.

It only compares objects that were configured with transaction AUT01.

Prerequisites

For the comparison to deliver a useful result, you must first have changed the logging settingsof tables, data elements or long text tables using transaction AUT01.

FeaturesIf you change the logging setting of a data element or table using transaction AUT01, thesystem writes the changed logging status to a table, known as the Customizing table. At thesame time, it stores an inactive version of the changed object on the database. Initially, theoriginal status of the object is retained on the database, and the system only writes thechanged status of the object to the database and deletes the inactive object once the objecthas been activated.

If you start transaction AUT01, the system compares the logging setting of all objects storedin the Customizing table with the equivalent objects on the database. If there are nodifferences between the logging settings, you go directly to the Change configuration of logging screen.

Any differences the system finds between the corresponding objects may be due to one of thefollowing factors:

• As a result of the import of a Support Package or correction, an object (data element or table) was changed the logging setting of which you already changed with AUT01before the upgrade in your system. In this case, you can decide whether to keep your existing logging setting for the object, or adopt the SAP standard setting.

• An error occurred when an object was activated, it was not activated, or was changedwith a different transaction (for example, SE11). As a result, an inactive version of theobject exists on the database in addition to the active version.In this case, you are not able to subsequently activate the object using transactionAUT01. Start the mass activator [Ext.] manually and activate the object concerned.

Before activation, ensure that no changes except the logging setting exist in theinactive version. If there are other changes, contact your system administrator.

• You scheduled an object activation job. The job has not yet been run. In this case, waituntil the job has run and activation is completed.

If the system finds differences, it lists the tables and data elements separately. You can then:

• Leave the differences as they stand (the case for all the factors listed above)

• Align the logging settings of the objects either to the status delivered by SAP or your own statues (in case 1)

•

Manually activate the objects concerned using the mass activator (in case 2). Here, youcan access information on the activated objects in the mass activator log.





Then start the Change configuration of logging function.

Aligning System Configuration Status

Prerequisites

You have already carried out logging for tables or data elements at least once. During thecomparison between the previous, customer-specific status and the current status, thesystem found differences (for example, after the import of a support packages).

Procedure

The system carries out the comparison every time the function Changeconfiguration of logging is started. If no differences are found, the screen is

skipped.

Align logging setting

The data elements that have different logging settings are listed in the top part of the screen,the tables in the bottom part....

1. Select the data element or table for which you want to change the logging setting.

2. Choose Copy own settings or Copy system settings, depending on which loggingsetting you want to copy.

A preview of the changed status is displayed.

3. In the Comment field, enter a comment on the change, if required.

4. Choose Copy .

The system marks the changed log setting, and the (already changed) icon isdisplayed in front of the Data elements or Tables column. The changed status is writtento the system the next time a save operation is performed.

5. Choose Continue.

The Change configuration of logging screen appears.

Display own settings

You can display all tables and data elements for which logging has changed compared withthe original system status.

Choose Goto → Own settings

In the top list, the system displays the affected data elements, and in the bottom list, itdisplays the affected tables.





Changing Table and Data Element Logging

Use

This function enables you to:

• determine whether the data element behind the table field to be changed is used intables that are connected to change document creation.

• activate and deactivate the logging of tables, data elements, and long texts withoutmaking technical modifications.

• assign the tables in which you changed the logging setting to a transaction.

Prerequisites

To create change documents, and therefore change the logging setting for data elements, theunderlying table must be included in a change document object. In addition, this changedocument object must be implemented in the application in which the data change is to belogged. If this is not the case, only the table as a whole can be logged.

The system defines whether a table is contained in a change document object,and whether this is implemented in the application. This can only be changed bymodifying the system.

Features

Where-used list

For the selected data element, you can first access a where-used list. Here, the system

determines which tables use the data element. However, it only takes into considerationtables that are assigned to a change document object.

When the change document objects are checked, the system only takes accountof registered change document objects, that is to say, those that were createdwith transaction SCDO.

As a result of this check, the system displays a list of the tables and table fields in which atleast one of the selected data elements is used.

Access the where-used list before every change to the logging setting todetermine possible effects on other tables.

Logging setting for data elements (change document creation)

Once you have selected a table, you can select one or more data elements and activate or deactivate the logging of changes made to the table fields that are linked to this data element.

If a change document object does not exist for the selected table, the systemdisplays a warning. Generally, a change to the logging setting has no effectwhere this data element is concerned (exception: use in non-registered changedocument objects).





If you change the logging setting of a data element, this takes effect across thewhole system on all table fields that are based on this data element.

You can only change the logging setting if the selected data element is not locked by another user or request. When you save the changed setting, the system first creates an inactiveversion of the changed data element. When you activate the settings, the system creates anactive version of the changed logging setting.

Change logging settings for whole tables

In addition to change document creation, you can select a table, and activate or deactivatelogging by selecting or deselecting the logging indicator. Here, too, when you save, thesystem first creates an inactive version, which then has to be activated.

Activate changed objects

Depending on your authorizations, the system uses different methods to activate the inactive

objects.Case 1: You have authorization for the mass activator:

In this case, after you save, the system starts the mass activator. You can process thechanged objects with the functions available in the mass activator.

Case 2: You do not have authorization for the mass activator:

In this case, the system activates the inactive objects in the background. You cannot accessthe objects.

You can choose Goto → Activation logs to display the logs of all objectsactivated in the system with the mass activator. For this, you need the followingauthorization:

S_DEVELOP: DEVCLASS=SDBT; OBJTYPE=PROG; OBJNAME=RADPROTA;ACTVT=03;

S_PROGRAMM: ACTVT=SUBMIT

Assign table to a transaction

Once you have finished changing the logging setting for tables or data elements, you canassign the changed table or changed change document to a transaction. It then appears inthe structure tree under Own assignments and can therefore be accessed more easily at alater date. In addition, the changed table or related change document object is displayed inthe SAP Easy Access Menu under the assigned transaction.

You can also assign tables or change document objects to transactions intransaction AUT01. However, we recommend that you use transaction AUT02 for this as it contains a wider range of assignment features.





Icons used:

The following icons indicate the object status. The icons appear in transaction AUT01 next tothe description of the table or data element.

• Configuration already complete

The logging setting of this table or data element has already been changed withtransaction AUT01 and the object activated.

• Already changed

The logging setting of the table or data element has been changed, but the change hasnot yet been saved.

• Inactive version exists

The logging setting of the table or data element has been changed and saved. Inaddition to the previously active version, the database contains a changed version withan inactive status. For the change to take effect for the object, you must activate itusing the mass activator [Ext.].

• Object lockedThe table or data element is currently locked from processing (by another user or request). Wait until the object is released for processing.

• Changeable

You can change the logging setting of this object.

Changing Logging Settings

PrerequisitesYou have authorization for the transaction Change configuration for logging (AUT01).

To change the logging characteristics of data elements, the underlying table must not belocked, and must be connected to change document creation.

Procedure

You make this setting in Customizing under Logistics - General → Engineering Change

Management → Logging → Change Configuration of Logging .

Change logging setting for a table

You can select the table you want to change using the assigned transaction or its technical

name.

Select table using transaction:...

1. In the list field above the object overview, select the Transaction entry.

2. Enter the transaction code and choose Continue.

If the transaction is included in the Own assignments overview, it is displayed with theassigned tables. If it does not, the message Assignment does not exist in menu tree appears in the status line. You must then call up the table using its technical name (seebelow).

3. Select the table you want by double clicking on it.

The data elements of the table are displayed in the right-hand part of the screen.Select table by its technical name:





If you know the technical name of the table:...

1. In the list field above the object overview, select the Table entry.

2. Enter the technical name of the table and choose Continue.

The data elements of the table are displayed in the right-hand part of the screen.

Change logging:...

1. Choose Display ↔ Change.

The Copy button is displayed to the left of this button.

2. Select the Logging indicator to activate logging for the object, or deselect the indicator to deactivate logging.

3. You can enter a comment in the text field next to the Logging indicator.

4. Choose Copy .

The changed table is flagged for saving, and the (already changed) icon isdisplayed to the left of Logging.

5. Choose Save.

6. Activate the object using the mass activator [Ext.] (see: Changing Table and DataElement Logging [Page 12])

If you want to be able to determine at a later date which changes were made tothe log settings for tables, you can use transaction AUT10 to execute a reportacross the table logs of table AUTTABLOG.

Change logging setting for data elements

Find data element by table:

If you know the technical name of the data element, you can search for it directly(see below).

...

1. Select one or more data elements that you want to change the logging setting for, andchoose Change.

2. Choose Use in change document objects to find out which change documentobjects the data elements are used in.

3. Select the indicator in the Logging column.

4. Enter a comment in the text line of the data element, if required.

5. Choose Copy .

The (already changed ) icon is displayed next to the Table fields column.

6. Choose Save.

7. Activate the object using the mass activator [Ext.] (see: Changing Table and DataElement Logging [Page 12])

If you want to be able to determine at a later date which changes were made tothe log settings for data elements, you can use transaction AUT10 to execute areport across the table logs of table AUTDTELLOG.

Call up data element directly:





If you know the technical name of the data element:...

1. In the list field above the object overview, select the Data element entry.

2. In the text field underneath it, enter the technical name of the data element and chooseContinue.

The data element is displayed in the right-hand part of the screen.

3. Proceed as described from point 2 above.

SAP recommends that, wherever possible, you search for the data elements viathe related table, and do not access them directly.

Check logging settings

If you are not authorized to change the logging settings, you can display them with thetransaction Display configuration of logging (transaction AUT03).

In the SAP Easy Access menu, choose Logistics → Central functions → Engineering →

Engineering Change Management →

Logging →

Configuration of Logging. Once you haveselected a table or data element, the system displays the current logging settings.

Tables and data elements are displayed in the same way as for the Changeconfiguration of logging function.

Result

The logging settings are changed in line with your entries, and the (configuration already complete) icon is displayed next to the changed object.





Assigning Changed Objects to Transactions

Use

You use this function to assign tables or change document objects, whose logging settingsyou changed, to transactions. This enables you to organize the changed objects and findthem again quickly.

Prerequisites

You need the relevant authorization, which depends on which transaction you want to carryout the assignment in.

Features

You can create the assignment of tables and change document objects in the transactionsChange configuration of logging (AUT01) and Change transaction/object assignment:overview (AUT02). You use this transaction if you do not have the authorization for transaction AUT01.

When you assign a table or change document object to a transaction, it and all its assignedobjects are displayed in the transactions Change configuration of logging (AUT01) andEvaluation of audit trail (AUT10) under Own assignments in the menu tree. This list of transactions and their assigned objects provides you with an overview of all changed objects,and makes it easier for you to find them again at a later date.

Assigning a Table to a Transaction

UseBy assigning changed objects (tables, change documents) to the required transactions, youcan create a graphical navigation aid. This makes it easier for you to find the objects again ata later date. In the SAP Easy Access menu, the transactions and their assigned objects aredisplayed under Own assignments.

Prerequisites

You have the authorization for this function. If you do not, contact your system administrator.

Procedure

You make this setting in Customizing under Logistics - General →

Engineering ChangeManagement → Logging → Change Transaction/Object Assignment .

Create navigation aid with transaction AUT02...

1. Call up transaction AUT02.

A list of transactions with their assigned tables and change document objects isdisplayed.

2. Choose New entries.

3. In the first column, enter the transaction that you want to assign a table or changedocument object to.

4. In the second column, enter the technical name of the change document object or in

the third column, enter the technical name of the table.





You can assign either one change document object or one table to a transaction,but not both, per line.

5. Choose Save.

Create navigation aid in the transaction Change configuration of logging

If you have authorization for the transaction Change configuration of logging, you can createthe navigation aid there, too:...

1. Select the table that you want to assign to a transaction.

2. On the icon bar, choose Change.

3. In the Assigned transaction code, enter the transaction that you want to assign thetable to.

4. Choose Copy and then Save.

SAP recommends that you carry out the assignment in transaction AUT02, asthis is easier to use.

ResultIn transactions AUT01 and AUT10, the selected transaction and its assigned table appear inthe Own assignments menu tree.





Logging Long Texts

Use

You can activate and deactivate logging for texts that you enter in certain applications in theform of comments or explanations. Like changes in tables, every change to these long texts iswritten to a logging table. By using evaluation functions, you can search for the logged longtexts using criteria you entered yourself.

Prerequisites

The system profile parameter rec/client must be active for every client in which you want tolog the long text tables STXL and STXH (see below).

You have activated table logging for the tables STXH and STXL.

You have implemented Note 561250 or your system has at least Support Package 12 for SAP_BASIS 620. This ensures that the archiving object BC_DBLOGS does not archive long

texts, but rather that all long texts are archived with archiving object ELR_LTXTS.

Features

Logging of long texts in logging table DBTABLOG

When a SAP System is customized, the user has the option of enhancing data for certainapplications be entering additional comments or explanations, known as long texts. Thesystem stores these long texts, with various attributes such as object value and ID, in thetables STXL (actual text) and STXH (header data).

If table logging is activated for tables STXL and STXH, each time a change is made to a longtext, the old long text is entered in the logging table DBTABLOG. The dataset in this tabletherefore rapidly increases. To prevent this, only long texts relevant to logging (for example,

for working in a controlled environment in the pharmaceuticals industry, GxP) and their historyshould be saved.

When table logging is active for STXL and STXH, the system writes all changed long texts toDBTABLOG. However, you can define restrictions by using the filter for long text logging[Page 24], namely for a series of long texts, you can define in advance whether changes areto be logged.

Deletion flag and deletion reports for unwanted long text logs

If long texts were logged, even though the logs are not required, you can delete them from thetable by selecting or deselecting a deletion flag in transaction AUT04 (all long text objects inthe system are listed in this transaction).

Report AUT_DEL, which can be run as a background job, looks through the list in transactionAUT04 to determine whether the deletion flag is selected for a long text object, and removesthese long text logs from table DBTABLOG. If the deletion flag is deselected at a later date,from this point in time the system stores all subsequent changes to the long text of this dataobject in table DBTABLOG.

When you start transaction AUT05, the deletion report AUT_DEL does not run as abackground job but is started immediately. SAP recommends that you only executetransaction AUT05 for test purposes and with small amounts of data.





Managing Long Texts

Use If you used transaction Evaluation of Audit Trail (AUT10) to evaluate changed data, you candisplay the texts that were created in addition to the data entered when certain functions wereperformed (for example, comments on quality reports, creation of batches). When selectinglong texts, the system searches only for changed long texts. It does not search for table logsor change documents.

You can use the deletion function in transaction AUT04 to delete long texts that are notrelevant for logging from logging table DBTABLOG. This enables you to keep the table assmall as possible.

Prerequisites You have carried out an evaluation of the long text logs (see Evaluating Logged Data [Page25]).

Procedure Display long texts ...

1. In the log list for the evaluation, select the entries that you want to display long texts for.

2. Choose Text old/new .

For the first entry, the system displays the original long text on the left-hand side of thescreen, and the changed long text on the right-hand side. Only unformatted text isdisplayed. Template text also appears, which is standard in some applications (for example, entering quality notifications). If you have changed parts of the document thatthe system does not display (for example, formatting and graphics), the system

displays a message at the beginning of the texts. In this case, you can use the Display function to display the long texts in the way that they were originally entered.

3. Choose or to display the long text for the previous change log or next change log.

If a new long text was created, nothing is displayed in the Old text column. If along text was deleted, nothing is displayed in the New text column.

Display additional data Choose Display additional data.

The system displays additional data (date changed, changed by, and so on) for the selectedlong text.

The data is displayed for the text that the cursor is currently positioned on.

Print long texts Choose Print.

The print dialog allows you to display or print the selected long text (cursor position, seeabove) and additional data in a print display.





Export long texts You can export the displayed old and new long texts (cursor position, see above) into a localfile so that you can search for differences in a word processing program, for example....

1. Choose Export to local file.

2. Specify the target folder and the format of the file that you want to export.

3. Choose Transfer.

Delete long text logs Selection of long text logs to be deleted ...

1. In transaction AUT04, select the required list entries and choose Delete.

The deletion flag is set. The system writes the current date and time to the columnsDate and Time. In this way, you configure the current client to delete from the loggingtable all long texts that are changed as of this time. (Deletion of long text logs is client-dependent.)

If you want to enter a different time from whether the system should delete changed long textsfrom the logging table:...

1. Choose Set time and enter the required time.

2. If you want to define filters for long text logs [Page 24], choose Adjust filter .

When the filter table is compared and data saved, the system and all itsapplication servers must be restarted. When transporting changes, note that thetarget system must also be completely restarted after the import.

3. Choose Continue.

Start deletion

SAP recommends that you only use transaction AUT05 for test purposes andwith small amounts of data. Long texts should generally be deleted as abackground job with report AUT_DEL.

Start the transaction Deletion of long texts (AUT05). A dialog box is displayed in which youcan choose one of two methods for deletion:

Start Immediately

Deletion starts immediately without any further requests for information.

Start with Selection

Before deletion, you can make the following settings to improve performance:

• Delete in the period from

If you specify a period for deletion, the program only deletes the long text logs withinthis period from the log table. If you do not enter a start date, the program selects thedate from the Customizing settings in AUT04 as the start date. If you do not enter anend date, the program deletes the logs up to the previous day.

Exception: You manually entered a start date but not an end date. In this case, theprogram only deletes the logs from the specified day.

• Packet size





In the Packet size parameter, you define the intervals (measured in number of datarecords) in which changes are permanently stored on the database. After each deletedpacket, the system displays a success message stating the total number of deleteddata records. During background processing, these messages are written to a job log.If the packet size is too high, the program may terminate. The ideal value depends onthe configuration of your database system; the default value in the system is 1000 .

• Delete in groups

In this method, all deletion operations are grouped by text objects, if the followingconditions are met:

All long texts of a text object are to be deleted

Start date and time are identical for all the long texts to be deleted for a textobject

This optimization can only be taken full advantage of if all the long texts of a textobjects are flagged for deletion in transaction AUT04, and the date and time areconfigured in exactly the same way for all these long texts. If you do not want to deleteall the long texts of a text object, at least the date and time should be configured in

exactly the same way for all the other long texts of a text object that are flagged for deletion.

You only get a restricted log. With this deletion method, the number of deleted datarecords can only be displayed at text object level. If you want a more detailed log withthe number of deleted data records at long text level, you cannot use this deletionmethod. With this method, if the number of deleted data records is partially displayed atlong text level, this indicates that the start date and time are not exactly the same for alllong texts belonging to this text object that were to be deleted. Check whether it ispossible to configure the start date and start time in exactly the same way for this textobject in transaction AUT04.

• Optimize start date

With this optimization feature, the oldest data record to be deleted is determined before

deletion is carried out. This date of the oldest data record is then relevant for thedeletion of all long texts. Long texts are only deleted as of this date. The settings intransaction AUT04 are not affected by this. You can only take full advantage of thisoption if you delete long texts at regular intervals.

• Partial log

You can use this indicator to request a partial log. If you set this indicator in connectionwith grouped deletion, you receive a partial log for each group. If you set this indicator with ungrouped deletion, you get the partial logs at text ID level.

Background processing

SAP recommends that you only use transaction AUT05 for test purposes and with smallamounts of data. Long texts should generally be deleted as a background job with reportAUT_DEL. Note that you use a variant here to indicate which deletion method should be usedto improve performance (groups and/or optimized start date).

SAP also recommends that you execute this as a background job in a period of low systemload. By scheduling this report as a background job at short intervals, the performance of boththe deletion function and the audit trail evaluation function is considerably improved. It is notpossible to give general information on how often this background job should be run. Theinterval depends on

• How many entries the system writes to log table DBTABLOG per time unit

• How often you create and change long texts





With both deletion types (direct or in the background), the system deletes the logentries irretrievably from the database. Once the deletion procedure iscomplete, a log is displayed.

Tracking changes during deletion of long text logsIf you want to know which changes were made in transaction AUT04, use transaction AUT10to carry out an evaluation of the table logs of table AUTDELTTXID.

Reactivating long text logging To include a long text in the logging table again, and therefore to log long text changes:...

1. In transaction AUT04, select the required list entry and choose Log .

2. Choose Continue.

For further information, see Logging Long Texts [Page 19]





Filter for Long Text Logging

Use

You have activated long text logging in your system. The changes to long texts cause a highdata load. The majority of changes are not needed, and the unwanted long text logs aretherefore deleted at regular intervals (report AUT_DEL or transaction AUT05). You can usethe filter for long text logging to exclude a series of long texts from logging, in order to reducethe data load and improve the runtime for deletion of the long text logs.

Prerequisites

You have applied Support Package 08 for component SAP_APPL 470 in your system.

Features

With the filter function for long text logging, you can define in advance whether changes are tobe logged for a series of long texts. When you change the long text, the system decideswhether the change needs to be logged. This reduces the data load and improves the runtimefor deletion of unwanted long text logs.

For performance reasons, the filter function is only defined at text object level. However, youstill need to delete long texts regularly, because long texts are only uniquely determined bythe text object and text ID. The only case in which you do not need to delete long texts is if you have set a deletion flag for complete text groups in transaction AUT04. (A text group iscomplete if all the text IDs in it are flagged for deletion and the date and time are standardizedfor deletion.)

In the transaction Configuration of long text logs (transaction AUT04), you define which textobjects you want to write to the filter table. If the filter table is empty, all long texts are logged.

You can empty the filter table by choosing Goto → Delete filter table.

After the filter table has been compared and data saved, the system and all itsapplication servers must be restarted. When transporting changes, note that thetarget system must also be completely restarted after the import.

Report AUT_DEL contains the indicator Consider filter table. If this indicator is set, the systemonly deletes the long text logs for long texts whose object is contained in the filter table.According to the configuration, logs for other text cannot exist, and therefore do not need tobe deleted.

Only deselect the indicator if you want to delete long text logs whose text objectsare not included in the filter table. These long text logs could come from a timewhen the filter function was not yet in use, for example.





Evaluating Logged Data

Use

You can use certain criteria (such as a specific period or user) to search for data that waschanged in the system. The data that is found in this way is sorted by table logs and changedocuments, and displayed in the form of a list. In this way, you can trace the change history of certain data, and therefore perform an evaluation of the data in the system that complies withGxP.

The evaluation only takes account of data whose value has changed (for examplemaster or movement/transaction data). If you changed the logging setting for anobject, it is not recorded during evaluation of the object concerned. An evaluationof transaction AUT01 is required here.

PrerequisitesTo search change documents, the corresponding transactions must be linked with the“change document creation” function, and they must be active. In addition, logging must beactive for the table fields containing changed data.

For the system to be able to display the results of the evaluation, in authorization objectC_AUT_TCD you must have the authorization for the transactions in which changes weremade. If you do not, the system cannot display the full results.

In connection with this, take account a possible transaction switch within anapplication (for example, transactions SM30 and SM34 are called in many

Customizing transactions).

Features

There are two modes for performing an evaluation: standard mode and extended mode.When you start the transaction, standard mode is called up initially.

In both modes, you first enter the selection requirements that you want the system to use tosearch for changed data. Selection conditions can include:

• Date and time of change

• Person who changed the data

• Transaction code used to make the change

and so on.

Once you start the search function, the system finds all the data that meets the selectionconditions, and displays this information in list form. If you double click on a list entry, you candisplay detailed information for this entry, such as the exact time of the change, the changeddata value, the person who made the change, and so on.

Carry out evaluation in standard mode

You do not require much technical knowledge to enter selection conditions in standard mode.However, evaluation takes longer in this mode because you do not enter many selectionconditions, and the system therefore searches an extensive dataset.

Selection conditions in standard mode include:

• Date and time period in which a change was made. This is a required entry.





• Name of the user who made a change to the data.

• Transaction to which a changed table or change document object was assigned. This isa required entry, but you can also enter a placeholder (such as ‘*‘).

You also have the following additional search options:

•

Long text If this option is activated, the system uses the selection criteria you entered to searchfor the related, changed long texts in addition to changed data (see Logging LongTexts [Page 19]).

• Evaluate details

This option only effects evaluations of table logs. If it is active, during evaluation thesystem does not just indicate that a change was made in the case of deleted andinserted data (indicator “D” for deleted and “I” for inserted), but also lists the only andnew data values.

Carry out evaluation in extended mode

In extended mode, you have not only the selection conditions available in standard mode, butalso a whole series of other selection conditions which you can use to define the search for changed data. This can reduce the evaluation time considerably. To enter the additionalselection conditions effectively, however, you require more in-depth technical knowledge of the processes and links in the logging functions of the SAP System.

There are four additional variants available for evaluation in extended mode:

• Only take account of change document objects

• Only search in table logs

• Search in change document objects and table logs

• Search in long texts

You select an evaluation variant by entering the selection conditions on the relevant tab page.

When evaluating table logs and change documents, you can use the following conditions tolimit selection in addition to those available for standard mode:

• Type of change (Insert, Update or Delete): only newly inserted, updated or deleted aresearched:

inserted : a new data record was added to a table.

updated : the data value in a table field was changed.

deleted : a data record was deleted from a table.

• Table name: technical name of the table you want to evaluate. The system onlysearches in the table you enter.

• Table field: technical name of the table fields you want to evaluate. The system onlysearches in the table fields you enter.

Variant 1: Only evaluate table logs:

If you only want the system to search in table logs, on the Table logs tab page you can enter the table keys of the table you want to evaluate.

SAP recommends that you use wildcards, because the table keys can alsocontain fields that you may not be aware of.

Variant 2: Only evaluate change document objects:





If you only want the system to search for change document objects, you can also enter thefollowing conditions:

Change document number: the number under which the change document is stored•

•

•

•

Object value

Change document object: technical name of the change document objectTable key: the key of the changed data record

Variant 3: Evaluate table logs and change document objects:

If you want to perform a combined search for change document objects and table logs, theselection criteria mentioned above for variants 1 and 2 are available on the relevant tab page.

Variant 4: Evaluate long text logs:

If you want to evaluate long text logs, you can enter the following selection conditions inaddition to those available for standard mode:

• Text object: describes the application object belonging to the text

• Text ID: more detailed specification of the text object

• Text name: together with the text object and text ID, identifies the text.

Once you have entered all the selection conditions, the following options are available to you:

• Copy current selection conditions and enter further combinations of selection conditions

• Delete current selection conditions, most recently copied selection conditions, or allcopied selection conditions

• Display a list of all selection conditions copied so far

• Display number of hits for the current selection criteria

The number of hits displayed by the system represents the hits found for theselection conditions currently visible on the screen. The system does not takeaccount of selection conditions that were already copied. We advise you todetermine the number of hits before every evaluation, to avoid a timeout or memory overflow if the selection is not detailed enough.

• Save or import own selection conditions as a variant.

Delete selection

You can delete selection conditions that you have already copied to the system at differentlevels:

• Delete current selection: the current selection conditions displayed on the screenare deleted (in standard and extended mode)

• Delete last copied selection: the selection conditions most recently copied totemporary storage are deleted (extended mode only)

• Delete complete selection: All selection criteria are deleted from temporary storage(extended mode only)





Display selection conditions

Choose Display selection conditions to list all selection conditions that you have written to

temporary storage with the Copy selection function since the last evaluation, sortedaccording to the sequence of your entries.

This function is always available in extended mode, and available in standardmode after an evaluation has been performed.

Check number of entries

Before the actual evaluation, you can use the Number of entries function to check howmany logs exist for the current selection conditions, to decide whether you need to reduce thenumber of logs by entering further selection conditions.

Change conditions that you have already written to temporary storage using Copy selection are not included in this check.

This check does not take account of authorizations and client dependencies. Therefore, it ispossible that fewer table logs and change document are included in the actual evaluation thanwere determined during the Number of entries check.

Store selection conditions as a variant

You can save a group of selection conditions as a separate variant, and quickly access it

using Get variant . If you have created a variant, the Evaluation of Audit Trail function(AUT10) starts immediately in extended mode (otherwise in standard mode).

Every user can create a separate variant.

An administrator with the appropriate authorization can also create user-independent variants in the variant maintenance for program AUT_REP10 .When entering selection conditions here, use only one of the followingsubscreens:

− 140: for change document objects and table logs

− 150: for table logs only

− 160: for change document objects only

− 170: for long texts only

See also: Maintaining Variants [Ext.] and Report Variant Types in QM [Ext.].

Run evaluation as background job

The following prerequisites must be met before an evaluation can be run as a background job:

• You have entered AUT_REP10 as the name of the program that is to be processed inthe background.

• The selection conditions must be stored as a variant. This must relate to one of theselection screens 140, 150, 160 or 170.

Long texts cannot be displayed in this type of evaluation





Entering Selection Conditions

Use

You enter selection conditions on which the system bases its search for changed and logged

data records. Depending on whether you are in standard or extended modes, you have adifferent number of selection conditions available to you.

Procedure

Enter as many selection conditions as possible, as this limits the search, and the results areavailable more quickly.

The entry of selection involves an and operation. As a result, the system only searches for data that meets all the selection conditions.

If you put several selection conditions into temporary storage using Copy selection inextended mode, and then start the evaluation, the system searches for all data records thatmatch at least one of the combinations of selection conditions that you copied.

Selection conditions in standard mode

1. Enter selection conditions on which the system bases its search for changed data in tablelogs or change documents.

• Starting date (required) and finishing date

• Starting and finishing time

• Changed by

• Transaction code (required, wildcards are allowed)

• Long text

•

Evaluate details

Selection conditions in extended mode...

1. Choose Switch standard mode ↔ Extended mode to go to extended mode.

2. In addition to the selection conditions in standard mode, enter the further, object-specific selection conditions on the relevant tab page:

• for change documents and table logs

• for table logs only

• for change documents only

• for long texts

3. Choose Copy selection.

The system writes the current selection for later evaluation to local temporary storage.

4. Enter further selection conditions or start the evaluation.

You can initially store any number of combinations of selection conditions locally, andthen perform a general evaluation for them all. The system then determines all datarecords that match at least one of the copied combination of selection conditions.

If you enter too many combinations of selection conditions, the evaluation may beterminated by a timeout or memory overflow.





Store selection conditions as a variant...

1. Choose My default .

2. Enter the required selection conditions and choose Continue.

3. Enter attributes for the variant, if required, and choose Save.

For each user ID, you can only store one variant, and this is stored under thename U_[user ID] (see Evaluating Logged Data [Page 25]).

To delete the variant again, choose Goto → Variants→ Delete.

Carrying Out Evaluations

Prerequisites

You have at least entered the required evaluation conditions (starting date and transactioncode).

Procedure

Choose Start evaluation.

The system starts the evaluation of the table logs, change documents, or long textsusing the selection conditions you entered.

Result

The system displays the results on the Audit Trail screen.

Audit Trail: x/y Transactions Evaluated is displayed in the title bar. Here, y stands for thenumber of transactions that can be evaluated, and x for the number of transactions that wereactually evaluated. If the two values are not identical, some of the transactions were notevaluated because you do not have the authorization for them.

For more information on non-evaluated transactions, see Evaluationconditions.

The results are displayed in two lists:

• Evaluation results of the table and long text logs

• Evaluation results for change documents

Either one or both lists are displayed, depending on whether you carried out an evaluation for table logs only, change documents only, or both.

In addition to the general selection conditions such as date, time, and person who made thechanges, each list also contains more detailed information about the change document objector table log (for example, the value before and after the change is displayed for each changeddata record).

Display changed contents of individual table field

If you have deleted or inserted data in several fields of a table row, these changes only

appear as a single entry in the evaluation of table logs. To list the details of the changes in theindividual table fields:...





1. Select one or more table logs.

2. Choose Data record.

In a further list, the system displays the changes to the individual files of the selected tablerow.

Display field contents in fullSometimes, the content of a table field is too long and cannot be displayed in its entirety. In

this case, the icon is displayed at the start of the table row.

Click on or double click on a field in the row.

The system then displays a dialog box containing the full contents of all table fields in theselected table row.

Display long texts...

1. Select a long text log.

2. Choose Text old/new .

The text prior to the change is displayed on the left-hand side of the screen, the text after thechange on the right-hand side of the screen.





Archiving Long Text Logs

Use You can archive logged long texts with archiving object ELR_LTXTS. A complete archivingcycle has the following main steps:

• Executing the preprocessing program:

The data to be archived is prepared for the write program.

• Generating the archive files:

With the help of the write program, the long texts to be archived are sequentially writteninto newly generated archive files.

Note that archiving is client-dependent.

• Executing the deletion program:

Once the long texts to be archived have been completely written to the archive files, thedeletion program removes them from the database. For security reasons, the systemfirst reads the archived data, and does not start the deletion run until this readoperation has been completed successfully.

SAP recommends that you execute the function Delete long text logs (reportAUT_DEL) before you start archiving. As a result, you ensure that irrelevantdata records are not archived.

Prerequisites

You have applied Support Package 12 for component SAP_APPL 470 and Note 561250 to

your system, or your system has at least Support Package 12 for SAP_BASIS 620. Thisensures that the archiving object BC_DBLOGS does not archive long texts, but rather that alllong texts are archived with archiving object ELR_LTXTS, and the above-mentioned functionsare available to you. You can only evaluate long text logs that were archived withELR_LTXTS.

If you changed the code page of the systems (for example as a result of an upgrade fromSAP R/3 4.6C to SAP R/3 Enterprise including a change to a two-byte Unicode code page),you have recorded in the system the time at which this code page switch took place. For further information on this, see Notes 513839 and 514967.

The archiving programs use the code page information to format the data. Adifferent data conversion may be required depending on the current code pageat the time of long text logging. Note that if the code page information isincorrect, data may be lost.

Features Preprocessing program The preprocessing program prepares the long text data for the write program, in order to savetime during the writing of the archive files.

On the selection screen of the preprocessing program, you can enter an end date for archiving in the Restrictions area. All the long texts that were created up to this date are

prepared for archiving.





This date must be in the past. In addition, it cannot fall in a period for which longtexts were already archived.

You can enter a packet size in the Technical control area. This defines the intervals(measured in number of long texts) in which changed data is permanently stored on thedatabase. If the packet size is too high, the program may terminate. The ideal value dependson the configuration of your database system; the default value in the system is 1000 .

If data exists that resulted from a previous preprocessing program, but was not archived, thepreprocessing program cannot be restarted. A restart of the preprocessing program is onlypossible once this data has been removed from the system. This can be done either byending the archiving cycle that was started (write program and deletion program), or bydiscarding the data of the preprocessing program by using program AUT_ARCH_UNDO.

Write program The write program writes the long texts to archive files. It is essential that the preprocessingprogram has been completely finished before the write program is run.

On the selection screen of the write program, you can choose between test and productionmode in the Processing Options area.

If the write program of the archiving object is executed in test mode, the system onlysimulates the archiving in accordance with the selection criteria you entered. An archive file isnot created. You receive statistics on the table entries that would have been written to thearchive in production mode, as well as the size and number of archive files that would havebeen created.

In production mode of the write program for the archiving object, the system creates archivefiles in accordance with your selection criteria. You receive statistics on the table entries thatwere written to the archive, as well as the size and number of archive files that were created.

In addition, you can enter a comment on the archiving run, which for example contains

information about the archived periods. This comment is displayed• In the overview of archiving runs in archive administration (transaction SARA). It can

also be changed here.

• During manual selection of archive files (e.g. evaluation programs), where it simplifiesselection of archive files.

Deletion program Once the data objects have been written to the archive files, they are deleted from thedatabase. It is essential that the write program has been completely finished before thedeletion program is run. Here, you can schedule the deletion program per archive file. Youcan do this manually or automatically. While the write program is running, you are not able tostart the deletion program.

In the Implementation Guide, you can choose SAP Web Application Server →

System Administration → Data Archiving → Archiving Object-Specific Customizing to make entries for the deletion program flow for the archivingobject.

As in the write program, on the selection screen of the deletion program, you can choosebetween test and production mode in the Processing Options area.

If you execute the deletion program of the archiving object in test mode, data is not deletedfrom the database; the deletion is only simulated. You receive statistics on the table entriesthat would have been deleted from the database in production mode.

If you execute the deletion program of the archiving object in production mode, the archiveddata is deleted from the database. You receive statistics about the deleted table entries.





Reload program You should only reload archived data to the database in exceptional situations. For example,it may be necessary to reload data if you discovered immediately after archiving that toomuch or the wrong data was archived. This data should be reloaded as soon as possible after archiving has been carried out.

After a release upgrade or code page switch, a reload of archived long textsmay lead to a loss of data, and therefore must not be carried out.

The reload program cannot be started if data of a non-archived preprocessingprogram exists. If necessary, discard this data using programAUT_ARCH_UNDO.

When you reload archived data, note that active info structures for the reloaded archive files

must be manually deconstructed (transaction SARI → Status).

As in the write program, on the selection screen of the reload program, you can choosebetween test and production mode in the Processing Options area.

Tracking details for archiving

If you want to track details for archiving, you can use transaction AUT10 to evaluate the tablelogs of table AUT_ARCH_HIST. You receive the following detailed information:

• Selection data of the preprocessing program (what data was included in this run)

• Status of the archiving run: empty (does not contain any data), preprocessing programexecuted, deletion program executed, or reload program executed

• Number of the archiving run in the ADK (Archive Development Kit)

• Date / time / user who executed preprocessing, deletion program or programAUT_ARCH_UNDO

In the standard system, logging is not active for AUT_ARCH_HIST. If you wantto use this function, you must activate table logging for table AUT_ARCH_HISTin transaction AUT01.





Evaluating Archived Long Texts

Prerequisites You have applied Support Package 12 for component SAP_APPL 470 in your system.

To be able to carry out evaluation using the Archive Explorer, at least one archive infostructure must be active and fully constructed.

SAP delivers archive info structure SAP_ELR_LTXTS as the minimum archive info structure.Field catalog SAP_ELR_LTXTS is available for archiving object ELR_LTXTS. On the basis of this, you can create your own info structures, if you want to select further fields.

If the archive info structure was not active at the time of archiving, you must construct this

manually (transaction SARI → Status).

For the evaluation of referenced long texts, there must be no period for which data exists onthe database that is followed by a period for which data is archived. The program determinesthe long text on the basis of the data in the archive. Under these conditions, it cannot be

guaranteed that the displayed texts are correct. For example, the system could display a longtext that resulted from a later change, because this is the next available change in thearchive. Archive the reloaded period again, or take organizational measures to ensure thatthe reference target of a long text does not fall in the reloaded period.

Activities Carrying out evaluations with the Archive Explorer ...

1. In transaction SARI, start the Archive Explorer.

2. Enter the archiving object and archive info structure.

3. On the selection screen, enter the required data, and choose Execute.

4. Double click on the required list entry and choose Display long text in the dialog boxthat appears.

The system displays the selected long text.

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