Efecto de la temperatura y la humedad relativa

According to the GAMP5 Guide, the software components of a system are

assigned to one of four software categories for the purpose of validating automated systems.

In terms of a PCS 7 system, this means that the individual components require different amount of effort for specification and testing depending on their software category.

Category 1: Infrastructure software

Scope of the testing:

- Check and document the version number - Check and document the correct installation

AS-OS Engineering Basic installation including editors (CFC, SFC,

Graphics Designer, Faceplate Designer, etc.)

Import/Export Assistant Check / read installation

PCS 7 Library Check / read installation

Version Cross Manager Check / read installation

PCS 7 Faceplates Check / read installation

WinCC Basic System Check / read installation

BATCH Base Check / read installation

BATCH ROP Library Check / read installation

Route Control Base Check / read installation

Category 3: Non-configured products

Scope of the testing:

- Check and document the version number - Check and document the correct installation - Function test

Batch Server Redundancy Set up redundancy and check functionality

WinCC redundancy Set up redundancy and check functionality

Web Server Set up and check Web connection

Lifebeat monitoring Function test

Time synchronization (Time master, SICLOCK)

Set up time synchronization and check functionality

SIMATIC PDM Basic Software Documentation of the configuration, test

field components in IQ/LoopCheck

SIMATIC Logon Test in the context of access control and user

permissions, user management

Category 4: Configured products

Scope of the testing:

- Check and document the version number

- Check and document the correct installation and configuration

- Risk-based test for proof of correct operation in the test environment and within the

business processes

Function block diagrams CFC templates (process tag types), CFC instances,

FBD (function block diagram), LAD (ladder diagram)

SFCs SFC Type / SFC Instances

Graphics Designer, Alarm and Trend Control

Graphics, faceplates, trend pictures, etc.

SIMATIC BATCH Engineering Create and test recipes, unit recipes,

equipment modules, etc.

Process Historian Set up archiving

Route Control Engineering Configuring and testing routes

OPC Server/Client, Open PCS 7 Configure interface and test data therein

Category 5: Customer-specific applications

Scope of the testing:

- Check and document the version number

- Planning and releasing the design

- Check and document the correct installation, the functions of the source code

- Risk-based test for proof of correct operation in the test environment and within the

business processes

Create blocks STL (statement list)

WinCC scripts VB and C scripts

BATCH API Interface Applicative interface to SIMATIC BATCH

While a PCS 7 system configured customer-specifically as a whole would usually have to be assigned to category 4 or sometimes even 5, the individual standard components to be installed (without configuration) should be treated in the same way as category 3 or 1.

The configuration part based on installed products, libraries, function blocks etc. then corresponds to category 4.

If "free code" is also programmed, this corresponds to category 5.

Procedure for functions of category 5

Provision must be made to expend more effort for specification and testing:

1. Creation of a functional description for the software 2. Specification of the function blocks used

3. Specification of the inputs and outputs used

4. Specification of the operator control and monitoring capability

5. Creation of software in accordance with specifications and programming guidelines

6. Testing of the structure for compliance with programming guidelines 7. Testing of the function for compliance with the functional description 8. Approval prior to use and/or duplication

Verification of software products

During verification of the "Standard software products" in use, checks are made to verify whether or not the installed software meets the requirements of the

specifications. These are usually products that are not specifically designed for a customer and which are freely available on the market, for example:

• Operating system

• SIMATIC PCS 7 software packages (OS Server/Client, Engineering System, etc.)

• SIMATIC options such as SIMATIC BATCH, SIMATIC Route Control, etc.

• Standard libraries

• Third-party software such as Acrobat Reader, MS Office (Word, Excel), etc.

Operating system and other software packages

The installed software can be verified by means of operating system functions. The information can be found in the Control Panel > Add/Remove Programs. All

installed software components are displayed there.

Installed SIMATIC software

Installed SIMATIC software can be verified using the "Installed SIMATIC software" software tool. The tool provides information about the SIMATIC software currently installed on the computer; the listing can also be printed or exported.

By using the SIMATIC Management Console, the installed software of all managed computers can be centrally recorded. The work involved in creating such

SIMATIC software licenses

The SIMATIC "Automation License Manager" tool provides information on the licenses currently installed on the PC. For this, the partition of the PC on which the licenses are installed must be selected in the Automation License Manager. The available system licenses are then shown on the right side of the window.

The SMMC also enables central access to the licenses of the managed computers.

SIMATIC PCS 7 installation log

When SIMATIC PCS 7 is installed, the current status of the installed system programs is saved in the "citamis.str" file. Retro-installations are also documented. Depending on the operating system installed, this file is located in either the "WINNT" or the "WINDOWS" folder.