Wincc Tia GMP
Wincc Tia GMP
Wincc Tia GMP
configuration in
WinCC Comfort /
Advanced (TIA Portal)
Note The Application Examples are not binding and do not claim to be complete
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Examples do not represent customer-specific solutions. They are only intended
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described in this Application Example shall be excluded. Such an exclusion shall
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body or health, guarantee for the quality of a product, fraudulent concealment of a
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Table of Contents
Table of Contents
Warranty and Liability ................................................................................................. 1
1 Task ..................................................................................................................... 4
2 Solution............................................................................................................... 5
2.1 Overview............................................................................................... 5
2.2 Hardware and software components ................................................... 6
2.2.1 Validity .................................................................................................. 6
2.2.2 Components used ................................................................................ 6
3 Basics ................................................................................................................. 7
3.1 Good Manufacturing Practice (GMP) ................................................... 7
3.2 WinCC Audit (TIA Portal) ..................................................................... 7
3.2.1 Function extension with WinCC Audit .................................................. 7
3.2.2 Supported HMI control panels .............................................................. 8
3.2.3 Licensing .............................................................................................. 8
3.2.4 Restrictions ........................................................................................... 8
3.3 User administration in GMP ................................................................. 8
4 Configuration ..................................................................................................... 9
4.1 Activating GMP ..................................................................................... 9
4.2 Licensing HMI control panel ............................................................... 10
4.2.1 Licensing SIMATIC panels ................................................................. 10
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1 Task
1 Task
Introduction
In industries, e.g. the pharmaceutical industry, or the food and luxury food industry,
there are various regulations regarding the traceability and documentation of
production data. These include, among others, the following regulations:
Complete tracing of operator control actions carried out by operators, using a
timestamp (creation of audit-trails)
Protection of important process steps using an electronic signature
Archiving of accountable user actions
The option package SIMATIC WinCC Audit (TIA Portal) supports you in
implementing a GMP-compliant configuration. Via the option package, you can also
automatically create, document and archive the Audit Trails.
Figure 1-2
Audit Trail
Time Operation Operator
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2 Solution
2.1 Overview
2 Solution
2.1 Overview
Schematic layout
The figure below shows a schematic overview of the most important components of
the solution:
Figure 2-1
Scalance X208
PROFINET / IE
Advantages
The solution presented here offers the following advantages:
Time and cost savings
Reducing the engineering effort
Electronic recording of Audit Trails as opposed to paper documentation
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2 Solution
2.2 Hardware and software components
The application example has been created with the following components:
Hardware components
Table 2-1
Component Qty. Article number Note
CPU 1516-3 PN/DP 1 6ES7516-3AN01-0AB0 -
SIMATIC Memory Card 1 6ES7954-8LL02-0AA0 -
256 Mbyte
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Software components
Table 2-2
Component Qty. Article number Note
STEP 7 Professional 1 6ES7822-1A.04-0YA5 -
V14 Upd 1
WinCC Advanced V14 1 6AV2102-0AA04-0A.5 -
Upd 1 (Engineering)
WinCC Runtime 1 6AV2104-0BA04-0A.0 -
Advanced 128
PowerTags V14 Upd 1
SIMATIC Logon V1.5 1 6ES7658-7B…-…. optional
SP3 Upd 3
SIMATIC Logon 6ES7658-7B.00-2YB0 optional
Remote Access for 3
Clients
SIMATIC WinCC Audit 1 6AV2107-0RP00-0B.0 -
for SIMATIC
Comfort/Mobile Panels
SIMATIC WinCC Audit 1 6AV2107-0RA00-0B.0 -
for Runtime Advanced
AuditViewer V7.0 SP3 1 -
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3 Basics
3.1 Good Manufacturing Practice (GMP)
3 Basics
3.1 Good Manufacturing Practice (GMP)
GMP stands for "Good Manufacturing Practice”. The term refers to certain
guidelines designed to ensure the quality of production of, e.g. pharmaceuticals,
substances, cosmetics and food. Next to production, the GMP guidelines also
demand high quality standards on processing, packaging and storage. If the GMP
guidelines are not complied with, companies are not allowed to manufacture the
respective products.
The most important regulatory basis is the Title 21 CFR Part 11 of the US Food
and Drug Administration on electronic data recording and electronic signatures.
Further country-specific and industry-specific regulations also apply.
Note Before implementing a project, observe the respective country- and industry-
specific laws and regulations concerning GMP.
Note A detailed description on the WinCC Audit functions can be found on the
websites about GMP validation (see link) under the section "GMP Engineering
Manuals”
Good Manufacturing Practice
If you activate the WinCC Audit (TIA Portal) option, the following additional
functions will be made available:
Archive Audit Trail
Audit Trail Protocol for printing archived changes
System function "Notify User Action"
"GMP relevant” markings for tags and recipes possible
Electronic signature
Archiving tags and messages with checksum
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3 Basics
3.3 User administration in GMP
The WinCC Audit (TIA Portal) option is available for the following control panels:
TP277
OP277
MP277
MP377
Comfort Panels
Mobile Panels 277 and Mobile Panel 2nd Generation
WinCC Runtime Advanced
3.2.3 Licensing
In order to be able to use the functions of WinCC Audit (TIA Portal) in the Runtime
of the operator panel, you need to license each used HMI control panel
individually. The following licenses are available for this purpose:
SIMATIC WinCC Audit for SIMATIC Panels: 6AV2107-0RP00-0B.0
SIMATIC WinCC Audit for Runtime Advanced: 6AV2107-0RA00-0B.0
How to license the different HMI control panels is described in Chapter 4.2 .
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3.2.4 Restrictions
If you use WinCC Audit (TIA Portal), some functions and configurations will be
restricted. Further information can be found in the manual "WinCC Advanced V14
– Options" in chapter 1.4.2 "Restrictions (Panels, RT Advanced)".
The manual can be found in the appendix of the entry "SIMATIC WinCC Advanced
V14":
https://support.industry.siemens.com/cs/ww/en/view/109742297
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4 Configuration
4.1 Activating GMP
4 Configuration
Prerequisite
In this chapter, you can find all necessary configuration steps on how to implement
a GMP-compliant configuration in WinCC. As a prerequisite, you already must
have created a project with at least one of the supported HMI control panels
(Chapter 3.2.2).
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4 Configuration
4.2 Licensing HMI control panel
Table 4-2
No. Action
1. Right-click on the control panel you would like to license (1).
In the context menu, select "HMI Device maintenance” (2).
Then click on "Authorize/License” (3).
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4 Configuration
4.2 Licensing HMI control panel
No. Action
2. Set the respective communication parameters (1).
Click on "Start search” (2).
Choose the control panel to be licensed (3).
Click on "Load” (4).
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4. Select the license "WinCC Audit for SIMATIC Panel” on your PC and drag it to the
"HMI_Panel”.
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4 Configuration
4.3 Configuring function extensions
No. Action
5. If you select the licensed SIMATIC Panel in the "Automation License Manager”
now, all licenses that have been loaded to the SIMATIC Panel will be displayed.
Licensing is complete and you can close the "Automation License Manager”.
If you have WinCC Runtime Advanced installed on your PC, the "Automation
License Manager” will automatically be installed as well. Therefore, the license
transfer works the same way as usual in SIMATIC STEP 7 (TIA Portal) or SIMATIC
WinCC (TIA Portal).
Further information on licensing can be found in the manual of the "SIMATIC
Automation License Manager”:
https://support.industry.siemens.com/cs/ww/en/view/102770153/70701911051
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4 Configuration
4.3 Configuring function extensions
No. Action
2. Open the "Audit Trail” tab (1).
Mark the automatically created "Audit Trail” in the chart (2).
In the inspector window, adjust the settings of the Audit Trail (3).
Note:
Information on how to store an archive file from a panel onto a network computer
can the found in the application example "Integrating HMI Control Panels in
TCP/IP Networks and access to a NAS or to a shared Windows folder”:
https://support.industry.siemens.com/cs/ww/en/view/92346478
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3. In the area navigation under "Settings”, you have the option to make further
settings.
4. Optional
In the inspector window, open the "Events” tab (1).
In the area navigation, click "Low free Space” (2).
Add the system function "ShowSystemAlarm” (3).
Enter a message text (4).
It will be output as soon as the storage space on the medium falls below the
configured minimum volume (from step 3).
Note A precise description of the individual parameters can be found in the manual
"WinCC Advanced V14 - Options” in chapter 1.2.3 "Parameters for Audit Trail”,
as well as in chapter 1.2.8 "Archiving concept of Audit Trail”.
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4 Configuration
4.3 Configuring function extensions
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4 Configuration
4.3 Configuring function extensions
This chapter describes how to capture and record a manual change of the tag
value in Audit Trail. This assumes, that GMP relevant tags have already been
created.
Table 4-5
No. Action
1. In the project navigation, open the standard tag table of the HMI control panel.
2. In the tag table, mark the tag relevant for GMP (1).
In the "Inspector window” open "properties” (2).
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4 Configuration
4.3 Configuring function extensions
No. Action
3. Activate the "GMP relevant” checkbox (1).
Open the drop-down list to select the confirmation type (2).
Select the confirmation type "Acknowledgment” (3).
Optional
Activate the checkbox "Comment required”, in case you want to capture an
additional comment during the change of the tag value in the Audit Trail.
4. Save your project and load it to your control panel.
Figure 4-1
Note Electronic signatures can also be realized centrally with SIMATIC Logon and its
included software component, SIMATIC Electronic Signature.
Further information is available in the manual of von "SIMATIC Logon V1.5.3" in
the chapter "What is SIMATIC Electronic Signature".
https://support.industry.siemens.com/cs/ww/en/view/109738714/3870564107
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4 Configuration
4.3 Configuring function extensions
This chapter describes how to capture and record a change of the recipe data in
Audit Trail. This assumes, that recipes complying with requirements of a GMP-
compliant configuration, have already been created.
General information on the recipes can the found in the manual of "WinCC
Advanced V14” in the chapter "Working with recipes (Basic Panels, Panels, RT
Advanced)”:
https://support.industry.siemens.com/cs/ww/en/view/109742297/91389190283
Table 4-6
No. Action
1. In the project navigation, open the "Recipes” of the HMI control panel.
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4 Configuration
4.3 Configuring function extensions
No. Action
3. Activate the checkbox "Record operator control actions in Audit Trail".
4. The checkboxes for sign loading and saving of recipe data are unlocked.
5. Optional
Activate the checkboxes "Sign loading of recipe data” and "Sign recipe data
saving”.
6. Save your project and load the configuration to the HMI control panel.
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4 Configuration
4.3 Configuring function extensions
Automatic recording
The following functions are automatically captured in Audit Trail in Runtime and
recorded:
user administration
– User logon and logoff
– Import user administration
Message system
– Messages acknowledged by the user
– Incorrect acknowledgment attempts
Archive
– Start and stop archive
– Open and close archive
– Delete and copy archive
– Start sequence archive
– Long-time archive
Manual recording
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Next to automatic recording, you can record user actions manually. For this
purpose, the system function "NotifyUserAction” is available to you.
The following table shows how to configure a manual recording, using the example
of a button. This assumes that there are already configured screens and buttons.
Table 4-7
No. Action
1. Open the directory "Screens” in the project navigation and open the screen with
the button, to which you would like to add a manual recording. In this application
example "Start screen”.
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4 Configuration
4.3 Configuring function extensions
No. Action
2. Select the "Button” (1).
In the Inspector window, click "Properties > Events” (2).
In the area navigation, click "Release” (3).
4. Fill in the category, the object name and the description that are to be entered in
the Audit Trail.
Depending on the control panel and options used, the use of system functions is
restricted.
In connection with WinCC Audit (TIA Portal), some system functions are recorded
in Audit Trail. For further system functions, an electronic signature may be
required.
Further information on system functions that are GMP-relevant can be found in the
manual "WinCC Advanced V14 – Options" in chapter 1.3.4 "Recording system
functions (Panels, RT Advanced)".
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4 Configuration
4.4 Evaluating Audit Trail
If you have selected the SD card of the panel as storage location for Audit Trail,
you first need to transfer the Audit Trail to a PC in order to be able to view it
afterwards.
In this regard, by using the system function "ArchiveProtocolData”, you can move
the Audit Trail to a connected network computer. During this, you need to observe
the following steps:
1. Close all archives (System function "CloseAllLogs”)
2. Then move the archive (System function "ArchiveLogFile”)
3. Open all archives again (System function "OpenAllLogs”).
Figure 4-4
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Further information on the system function can the found in the manual of "WinCC
Advanced V14” in the chapter "ArchiveLogFile (Panels, RT Advanced)”:
https://support.industry.siemens.com/cs/ww/en/view/109742297/76202771339
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4 Configuration
4.4 Evaluating Audit Trail
The following table shows you how to evaluate Audit Trail via "SIMATIC Audit
Viewer”.
Note The "SIMATIC Audit Viewer” can be found on the installation CD of WinCC
Advanced V14 in the "Support” folder.
Prerequisite
To view the Audit Trail, you need to tranfer it from the control panel to a PC.
Note To be able to open an RBD file with WinCC Audit Viewer, you need to switch the
Windows format to "English (USA)” in the Windows Control Panel, see Table 4-4
Step 3.
Table 4-8
No. Action
5. Open "All Programs > Siemens Automation > Options and Tools > HMI Tools” and
click on "WinCC Audit Viewer”.
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4 Configuration
4.4 Evaluating Audit Trail
No. Action
7. Click on "Audit Trail / Backups /Archives / Data records” to select an Audit Trail
(1).
Navigate to the storage location of the Audit Trail and select it (2).
Click on "Open” (3).
In "SQL Server / Audit Trail Browser”, the selected Audit Trail appears.
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8. Then click on "OK” in "SQL Server / Audit Trail Browser” to acknowledge the
selection.
9. In "SIMATIC Audit Viewer”, all recorded user actions of the Audit Trail are
displayed. The "Data Validity Indicator” shows you, whether the Audit Trail file has
been modified after the creation.
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4 Configuration
4.4 Evaluating Audit Trail
In WinCC (TIA Portal), reports can be generated automatically. Therefore, you can
also document and archive the Audit Trail. This chapter shows you how to record
the Audit Trail in WinCC Advanced.
Note General information on reports in WinCC (TIA Portal) can the found in the
manual of "WinCC Advanced V14” in the chapter "Working with reports (Panels,
RT Advanced)”:
https://support.industry.siemens.com/cs/ww/en/view/109742297/91449612811
Table 4-9
No. Action
1. Open the "Reports” folder in the HMI control panel project navigation (1).
Add a new report (2).
Rename the report to "ReportAudit” (3).
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2. In the work area, open the "Controls” task card and open the "Controls” tab
(1).
Select the "Print audit trail” control and drag it into the "Detail page” area via
Drag & Drop (2).
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4 Configuration
4.4 Evaluating Audit Trail
No. Action
3. Optional
Adjust the header and footer line according to your specifications.
Further information can be found in the manual "WinCC Advanced V14" in the
chapter "Objects and reports (Panels, RT Advanced)”:
https://support.industry.siemens.com/cs/ww/en/view/109742297/74775254539
4. The Archive Trail Protocol has now been configured.
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55
6 History
Table 1-2
Version Date Modifications
V1.0 05/2017 First version
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