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Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005 Exaquantum/Batch Validation Configuration Guidance (PM36J04B91-01E_001) Industrial Automation Systems Division Validation Configuration Guidance

Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

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Page 1: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Yokogawa Electric Corporation

Exaquantum/Batch Validation Planning Guide – Issue ACopyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Industrial Automation Systems Division

Validation Configuration Guidance

Page 2: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 2Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Contents

Time Issues– Time Zones

– Time Synchronization

System Security– Limiting Access

– Accounts & Passwords

– BatchWeb Clients

Audit Trail– Operational audit trail

– Configuration data

– System data

Part 11 License Features

CS Batch 3000 Configuration for ABDC

Page 3: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Yokogawa Electric Corporation

Exaquantum/Batch Validation Planning Guide – Issue ACopyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Industrial Automation Systems Division

Time Issues

Page 4: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 4Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Issues

Time Zones– Time Scenarios

– Reports

– Summer Time

Time Synchronization Scenarios– Auto Batch Data Collection (ABDC)

– Custom Batch Data Collection (CBDC)

– ABDC & CBDC

– Time Synchronization with External Time Source

Time Recommendations

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Zones

All data is stored as UTC– UTC = Universal Coordinated Time (~GMT)

When collected and written to the database time stamps are converted from local time to UTC– The original time zone is not saved

When data is displayed in BatchWeb time stamps are converted from UTC to the web server’s local time– If the web server is in the same time zone as the DCS was then

• displayed time will match local time records

– If the web server is in a different time zone than the DCS then • there will be a time difference

Reports– Report designer has option to fetch time in UTC or Local Time

• Database Table time columns are in UTC• Database View have both UTC and Local Time columns for each time

value

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time – Scenario #1

Exaquantum/Batch located with DCS in eastern U.S.

BatchWeb clients in eastern U.S. and Europe see the same times in BatchWeb since the Web Server’s time zone is –05:00

DCSEQB

ServerWeb

Server

BatchWeb Client

BatchWeb Client

Time Zone–05:00

Time Zone 2+01:00

Event occurs at 3:12 PM (15:12) local time

Stored in database as 20:12 UTC

BatchWeb displays time as 3:12 PM using Web Server’s time and locale settings

Report designers have option of Table data in UTC or View data in the server’s local time

Report configuration sets how BatchWeb views will see times in reports

ReportPackag

e

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time – Scenario #2 - Recommended

Exaquantum/Batch located with DCS in eastern U.S.

Exaquantum/Batch Server’s and Web Server’s local time is UTC

All BatchWeb clients and all reports use UTC time

DCS-05:00

EQB Server

UTC

Web Server

UTC

BatchWeb Client-05:00

BatchWeb Client+01:00

Time Zone–05:00

Time Zone 2+01:00

Event occurs at 3:12 PM (15:12) local time

Stored in database as 20:12 UTC

BatchWeb displays time as 20:12 (UTC) using Web Server’s time and locale settings

Report designers have option of Table data in UTC or View data in the server’s local time

Report configuration sets how BatchWeb views will see times in reports

ReportPackag

e

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Reports – Time Zones

Reports may obtain – Raw data from the

database Tables or– Data from the database

Views

There is no difference for data other than time values

There is a difference in Time Values– Tables return data in UTC– Views contain time values

in both UTC and server’s local time

– Report Designer decides which time value to use

BatchWeb always uses the Web Server’s local time

Local TimeWeb Server’s Date/Time Format Used

Local TimeDate/Time Format set in Excel

UTC Time

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time – Summer Time

When the Exaquantum/Batch Server’s operating system changes between summer and normal time time stamps are converted to UTC using the correct offset

No need for human intervention

1 amEST

0600UTC

3 amEDT

4 amEDT

0800UTC

0700UTC Time

1 amEDT

0500UTC

1 amEST

2 amEST

0700UTC

0600UTC

Start of Summer Time(Daylight Savings Time)

End of Summer Time(Daylight Savings Time)

EST = Eastern Standard Time (U.S.)EDT = Eastern Daylight Time (U.S. Summer Time)UTC = Universal Coordinated Time (GMT)

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Synchronization

Clocks of Exaquantum/Batch and all data sources must be synchronized– Lack of synchronization will lead to conflicting date/time data

Exaquantum/Batch server’s clock should be synchronized to the Exaopc Station– Exaopc Station is synchronized by V-Net

– Refer to CS 3000 Part 11 TI for information CS 3000 time management

• Explains how system clock can be synchronized with external time sources

Web Server should be synchronized with the Exaquantum/Batch server or directly to the Exaopc Station

BatchWeb clients are each responsible for their own synchronization– BatchWeb times are set by the web server, not the client

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Synchronization – ABDC Scenario

When Automatic Batch Data Collection (ABDC) is used– Exaquantum/Batch should be synchronized with CS Batch 3000 via the

Exaopc server

Exaquantum/Batch Server

Web Server

BatchWeb Client

FCS

Exaopc

Server

HIS

Vnet or Vnet/IP

Ethernet

Exaquantum/Batch Server’s time is

synchronized to the Exaopc Server’s Time

Vnet or Vnet/IP is a synchronized bus

All station’s clocks are automatically synchronized

If a separate Web Server is used it

should be synchronized to

the Exaopc Server

BatchWeb Clients do not have to be synchronized to

server

OK to use Windows Domain time

synchronization

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Synchronization – CBDC Scenario

When Custom Batch Data Collection (CBDC) is used– Synchronization scheme depends upon capabilities of the OPC server

Options:– Exaquantum/Batch synchronizes with the OPC Data Access Server– OPC Data Access Server synchronizes with Exaquantum/Batch server– Exaquantum/Batch synchronizes with the control system

Exaquantum/Batch Server

Web Server

BatchWeb Client

OPC Serve

r

Ethernet

Control System

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Synchronization – ABDC & CBDC Scenario

When Automatic Batch Data Collection (ABDC) and Custom Batch Data Collection (CBDC) are used– Exaquantum/Batch, OPC servers and all control/lab/information systems

should be synchronized with a single time source– Synchronization paths dependent upon capabilities of the systems– All systems should use the same time zone

Exaquantum/Batch Server

Web Server

Exaopc Server

Ethernet

Exaopc Server

CS 3000

CS Batch 3000

OPC Server

PLC

OPC Server

LIMS

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Synchronization – External Time Source

Synchronization provides system wide time consistency– Not necessary the correct time

Accurate time values can only be achieved using an external time source– Example: GPS time – The time master should be configured to synch to the external time source

Exaquantum/Batch Server

Web Server

Exaopc Server

Ethernet

Exaopc Server

CS 3000

CS Batch 3000

OPC Server

PLC

OPC Server

LIMS

External Time

Source

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Time Recommendations

Synchronize Exaquantum/Batch with the control systems– For Automatic Batch Data Collection

• Sync Exaquantum/Batch server to the Exaopc Station

– For Custom Batch Data Collection• Sync Exaquantum/Batch Data Collection to the control system

• If multiple control systems are involved assign one as the master and synchronize Exaquantum/Batch and other control systems to it

– Use an external time source when time accuracy is critical

– Refer to TI33Q01A61-01E, “CENTUM CS 1000/CS 3000 Yokogawa’s Approach to meeting FDA 21 CFR Part 11”, section 4 for information about CS Batch 3000 time synchronization

Use a single time zone for entire system– Recommend using UTC (GMT)

– Do not use daylight savings time (summer time) adjustment• Can cause confusion when reading historical data

– Remember: BatchWeb time values use the Web Server’s time zone

• They do not use the web client’s time zone

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Yokogawa Electric Corporation

Exaquantum/Batch Validation Planning Guide – Issue ACopyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Industrial Automation Systems Division

System Security

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

System Security

Limiting access– Physical

– Electronic

Windows security

Database security

Web Server security

Access control

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

System Security

Exaquantum/Batch should be operated within a secure intranet

System security should be an on-going activity – Must be done in cooperation with corporate policies and IT group

No pre-set list of recommendations will work in all cases

This presentation provides configuration guidance for certain aspects of security configuration

Yokogawa can provide consulting services to customize system security measures

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Limiting Access

Unauthorized access– An intruder who has breached the corporate firewall or physical

security

– An employee who is not authorized to access specific Exaquantum/Batch functions or has bypassed procedures

Physical Access– Physical access to Exaquantum/Batch servers should be

controlled• Normal plant security• Locked doors on server room• Limit access to trusted and trained personnel

Electronic Access– Firewalls limit external access

– Account management limits internal access

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Microsoft Products

Microsoft publishes extensive information on securing their products

Windows 2000/2003www.microsoft.com/security

www.microsoft.com/security/guidance/prodtech/Windows2000.mspx

SQL Server 2000www.microsoft.com/technet/security/prodtech/dbsql/default.mspx

www.microsoft.com/sql/techinfo/administration/2000/security/

Internet Information Server (IIS) – Microsoft’s Web Serverhttp://support.microsoft.com/default.aspx?scid=fh;EN-US;iis50

http://support.microsoft.com/default.aspx?scid=kb;en-us;300390&sd=tech

Windows updates– Apply only apply after Yokogawa has announced support for an

update

– Windows 2000/2003 Server (includes IIS Web Server)

– SQL Server 2000

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

User Account Settings

Use standard Windows account options– Lockout after 3 failed attempts

– Automatic reset after timeout

Disable accounts – do not delete them– Deleted account names cannot be used again

– Disabling accounts prevents duplicating account names over time

Disable Guest account– Create custom Guest account with different name if needed

Windows 2000/2003 Administrative Tools– Computer Management Program

• Use “Local Users and Groups” to manage accounts

– Local Security Settings• Use to set security policy

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Account Policy Settings

Local Security Settings– Access in Administrative Tools menu

– Use to set • Account policies• Rights (e.g. ability to shutdown the computer)• Security options (e.g. not displaying last logged last user name in

logon screen)• Audit trail policy (e.g. types of events to log)

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Intrusion detection

Enable Windows security auditing– Done in Local Security Settings program

– Writes security events to event log

SOP to monitor security event log to detect intrusion attempts

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Registering Users

1 time setup– Create “role” based domain groups

– Add “role” based domain groups to local EQB server groups

for each new user– Domain account

– Assign to a domain “role” group

– Fill in Full Name field for each account• Used to identify account owner• Account name not used to minimize

publicizing it

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Registering Users

Each person using Exaquantum/Batch must1. Have a Windows 2000 or Windows 2003 account

2. The account must have the privilege to access Exaquantum/Batch

Managing Windows 2000/2003 accounts– System Administrators create Windows 2000/2003 accounts

– Domain or local (local to the computer) accounts may be used• Domain administrators must manage domain accounts

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Adding New Windows User (1 of 2)

Use Computer Management program– In Windows 2000/2003 Administrative Tools on the Start Menu

Select “System Tools”, “Local Users and Groups”, “Users”

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Adding New Windows User (2 of 2)

Select “New User” on the “Action” menu

New User dialog box opens

Complete this to create a new user

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Assigning Privileges

Double click on the account name in Computer Management – Account Properties dialog is

displayed

– Click on the “Member Of” tab to view current privileges

Privileges are assigned by placing an account in a Windows 2000/2003 Group– Same technique as making a

user an Administrator or Power User

Add Privileges– Use Add button to add local

groups to the list

Remove Privileges– Select group in the list, click

Remove button

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Using Domain Groups

Domain administrators must assign privileges

Domain groups should be role based– QBAdministrator

– QBEngineer

Domain accounts made members of domain group

Dialog as viewed on Domain Controller

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Using Domain Groups

Add domain group to the Exaquantum/Batch server’s groups to grant privileges to a role

Example– Exaquantum/Batch servers

QAdministrator group

– Add domain QBAdministrator group as a member of the local QAdministrator group

• Gives all members of domain QBAdministrator group privilege of the local QAdministrator group

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Automatic Lockout During Inactivity

Reduces chance of unauthorized actions at unattended consoles– If user does not log out/lock computer when away unauthorized

user may use their account

Screen saver can lock computer after period of inactivity– Standard Windows 2000/2003 screen

saver sufficient for most cases

– Require logon after lock-out

– No industry standard for duration of period of inactivity

3rd party transparent screen saver can be used to allow viewing of screen during lock-out– One example ishttp://www.e-motional.com/TScreenLock.htm

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

BatchWeb Logon

BatchWeb uses Windows Authentication

If domain accounts are used BatchWeb requires access to a domain controller– User must logon

If local groups are used– Matching account/password on Remote

user’s computer and web server provides unchallenged logon

If web server and web client have matching account name and different passwords or web server does not have the account name locally– User must logon

If web server has account and the account does not have QUserGroup access– Access denied

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Password Management

Key Exaquantum/Batch and CS Batch 3000 accounts– Accounts:

• Quantumuser – Exaquantum/Batch administrator account• Exa – Exaopc server’s default account• Centum – CS Batch 3000 default account• sa – SQL Server administrator account

Password policies– Use strong passwords for administrator accounts

– Do not change frequently• Changing passwords increase possibility of mis-matches and

operational interruptions

Create procedure password management procedure– Frequency of changes

– Method, order & checklist for changing accounts

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Password Complexity

Windows 2000/2003 can be configured to force passwords to have a minimum level of complexity – Default password filter (passfilt.dll) requires that a password:

• Does not contain all or part of the user's account name • Is at least six characters in length • Contains characters from three of the following four

categories: • English upper case characters (A..Z) • English lower case characters (a..z) • Base 10 digits (0..9) • Nonalphanumeric (For example, !,$#,%)

– Complexity requirements are enforced upon password change or creation.

– To create custom password filters, refer to the Microsoft Platform Software Development Kit and the Microsoft Knowledge Base.

– From:http://msdn.microsoft.com/library/default.asp?url=/library/en-us/gp/

504.asp

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BatchWeb Clients

Internet Explorer settings

Secure Browser

Data entry

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Required IE Settings for BatchWeb (1/2)

Settings required for Exaquantum ActiveX Controls

Internet Options | Security– Local Intranet– Custom Level

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Required IE Settings for BatchWeb (2/2)

Security tab– Enable

• Download signed ActiveX controls

• Initialize and script ActiveX controls

• Run ActiveX controls and plug-ins

• Script ActiveX controls marked as safe for scripting

– User Authentication • “Automation logon with current name and

password”

Connections tab– LAN Settings

• If proxy used, check “Bypass proxy server for local addresses”

Advanced tab | Security– Enable Integrated Windows Authentication

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Yokogawa Secure Browser

Secure Browser is part of the YCA ETSPortal product– Available as a separate installation

Custom program encompassing the Microsoft Internet Explorer ActiveX control

Limits users access to IE functions

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Secure Browser Features

Only limited set of features exposed– Toolbars

• Back/Forward• Stop• Refresh• Home• Print• Read only URL selection

– Menus• Print, Print Setup, Exit, Toolbar and Navigation Bar(hide/show), Help

No access to other IE features– File system using File | Open/Save/Save As

– Favorites

– Internet Options

– Mail and News

– Windows Update …

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Secure Browser Uses

Use with CS Batch 3000 HIS to restrict file system access by operators

Plant floor kiosk type computers

Any environment where users required to have limited web access

Dedicated BatchWeb program– Home batch can be BatchWeb

• Normal IE can be used with a different home page

– Desktop shortcuts to BatchWeb• IE can be used for normal web uses

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

BatchWeb Data Entry

BatchWeb is primarily for viewing data

Entering data in BatchWeb– Operational Data

• Formula items, values• Performance ratings• Report

– Approve, Check-out/in, Delete

– Personalization data• System wide• Account specific

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BatchWeb Personalization data

System wide– Batch trend templates

– Quick Link entries

Account specific– MyList

– View options

– Related Links settings

– Filter settings

– Selected items

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Yokogawa Electric Corporation

Exaquantum/Batch Validation Planning Guide – Issue ACopyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Industrial Automation Systems Division

Audit Trail

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Audit Trail

Operational audit trail– Identification of manually entered data

– Reporting

– Exporting

Configuration data

System data– Windows logs

– SQL Server logs

– IIS logs

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Operational Audit Trail

Operations records– Actions taken by operators on using CS Batch 3000 are recorded

as events• If associated with a batch this association is maintained in

Exaquantum/Batch• If not associated with a batch the timestamp may be used to find

actions taken during the time a batch was running

– Changes to property values are recorded in the PropertyHistory table

• Changes in property values from start of batch to end of batch are recorded

• Record made even if no human intervention– Formula value changes are recorded so changes made by SEBOL or CS

Batch 3000 operators are recorded

Reports for FDA inspectors– Use Excel or 3rd party report package

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Manual Entry Audit Trail

Recorded in AuditLog table in QBatch database– BatchWeb

• New formula item• Change formula item value• Approve report• Change performance rating value

– Reports run • Manually from BatchWeb• Scheduled on time or batch event

– Performance rating calculations• Option to enable or disable log messages

Database view “AuditLogReportView” has same information with time stamps in both local and UTC– Data from table or view may be included in reports

• Recommend the view be used

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Data Collection Program Audit Trail

The Property History Table in the QBatch database contains an audit trail of all changes to batch properties by the data collection programs– Properties of batches, unit recipes and operations

– Formula item values • E.g. from the start of the batch to the end of the batch any changes

of to a value are recorded

Property history data includes– Time stamp (UTC)

– Identification of the property changed

– Old and new value

– Identification if the change represents a new item or a modified item

All changes are by ABDC or CBDC programs, not manual entries

May be included in reports

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Audit Trail Contents

Time stamp

User name– Not for PropertyHistory changes

(all changes by programs)

Computer name or IP address– Not for PropertyHistory changes

(all changes by server)

Identification of data changed

Old and new values

Reason for change– Not for PropertyHistory changes

(all changes due to normal data collection)

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Reports for FDA Audits

Reports used to meet FDA audit requests– Exaquantum/Batch Report Package may be used

• Excel based• PDF output

– 3rd Party report package may be used• Crystal reports• Corporate reporting packages

All operational, configuration and meta-data are stored in the database and available to any report

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Configuration Data

Configuration changes not recorded by an audit trail– Must be covered by procedures– Reports can be created to record snapshots of configuration data

• Reports could be triggered on database changes (programming required)

Configuration programs– System Configuration Tool– Report Template Manager– Equipment Configuration Tool– Custom Batch Data Collection Tool– Administration Tools– Other Exaquantum configuration tools may optionally be used:

• Exaquantum Explorer, Database Creation Tool, Graphics Editor,…

Report template approvals are recorded– Esig data stored in ReportTemplateVersion table

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

System Data

Log files are the audit trails for system level events

There are different log files for each product

Windows 2000/2003– Application, Security, System log files

SQL Server– Logon data may be logged to the Windows Application Log

– C2 Level security logging may be used• Extensive, adds performance load• Monitors database administrator also

– Database Tracing may be used• Set and managed by database administrator

IIS (Internet Information Server)– Logging may be enabled to track web site access

– Use to check for unauthorized access and/or analyze which parts of BatchWeb users use most/least

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Window Log File Management

Windows Logs– Application

• Contains Exaquantum/Batch program messages– Normal operation and error messages

– Security• Empty unless Local Security Policy used to turn on security auditing

– System• Contains operating system and some program messages

Windows log files must be periodically examined for– Size – save and empty log file before it is full and information log

– Contents – look for errors, security problems, normal behavior

View log files using Event Viewer– Control Panel | Administrative Tools | Event Viewer

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Windows Log Configuration

Set log file size

Periodically save and clear the logs

Permit overwriting of logs as needed

Set max log size to 4096 KB or greater– Reduces risk that a repetitive

error will obscure other messages

Either manually (via SOP) or automatically (via 3rd party software) save contents of logs prior to log file filling up and older contents overwritten– If manual – check size frequently,

save and clear contents before itfills up

Current Size

Prompted to save file before it is cleared

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Tracking Administrators Actions

Ultimately rely on trust

Options for tracking administrator actions – Not recommended, but if necessary

– Use separate Windows and Database administrators• All administrators should report outside of the production and quality

organizations to minimize production performance pressure

– Have non-Windows administrator check Window log files for continuity and abnormal actions in addition to checks by Windows administrator

– Enforce C2 security in SQL Server• Monitor SQL Server log files

– Use 3rd party packages to analyze log files

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Yokogawa Electric Corporation

Exaquantum/Batch Validation Planning Guide – Issue ACopyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Industrial Automation Systems Division

Part 11 License Features

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Exaquantum/Batch Part 11 License

Exaquantum/Batch has an optional license that enables features useful when working with Part 11

Features enabled with the license:– Electronic signature for manual data entry

– Signature manifest data and icon is displayed to indicate manually changed values

– Report output must be approved with an electronic signature

– Report check out/in feature is disabled to increase report data integrity

Other features such as audit trails and access controls are part of the base product offering

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Electronic Signatures

Electronic signatures required for data entry (Single Signature per entry)– BatchWeb

• New formula item value• New formula item• Manual performance rating value• Approve report

– Report Template Manager• Report template approval

Signature manifest data and/or icon displayed in BatchWeb to indicate manually changed values– Signature Manifest Data:

• Signed By• Date Signed• Reason

Report Excel Files cannot be checked out

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

BatchWeb Manual Performance Rating Impact

View Esig Esig Icon Esig Manifest

For Batches

For Unit Recipes

Performance Rating Manual Entry

X X X

Batch List X X

Batch Property Sheet

X X

Batch Performance Rating Chart

X X X

Gantt Chart X X X

Unit Recipe List X X X

Unit Recipe Property Sheet

X X

Unit Utilization Chart X X

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Performance Rating Manual Entry (Batch)

Signature Manifest shows data for previous rating value change

Electronic Signature required to change rating value

With Part 11 License

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Performance Rating Manual Entry (Batch)

Electronic Signature NOT required to change rating value

Without Part 11 License

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Performance Rating Manual Entry (Unit Recipe)

Same type of display features for manual unit recipe performance ratings as for batch ratings.

With Part 11 License

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Performance Rating Manual Entry (Unit Recipe)

Without Part 11 License

Electronic Signature NOT required

Same type of display features for manual unit recipe performance ratings as for batch ratings.

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch List

Signature Manifest Icon indicates value was changed using electronic signature

Signature Manifest may be viewed by clicking the Batch ID to display the Batch Property Sheet

With Part 11 License

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch List

Without Part 11 License

No Signature Manifest Icon to indicate Performance Rating was manually changed

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Page 65Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Property Sheet

Signature Manifest for manually entered batchperformance rating

With Part 11 License

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Page 66Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Property Sheet

Without Part 11 License

Signature Manifest Icon & Signature Manifest are NOT displayed

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Performance Rating Chart

Batches with changed rating values are shown with a red bar

Signature Manifest is listed in a table below the chart

With Part 11 License

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Page 68Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Performance Rating Chart

Without Part 11 License

Batches with changed rating values are shown with a red bar

Signature Manifest Table is not displayed

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Performance Rating Chart (for Unit Recipe)

Unit recipes with changed rating values are shown with a red bar

Signature Manifest is listed in a table below the chart

Unit Recipe Selected

With Part 11 License

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Without Part 11 License

Unit recipes with changed rating values are shown with a red bar

No Signature Manifest Table

Unit Recipe Selected

Batch Performance Rating Chart (for Unit Recipe)

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Gantt Chart

Manually entered Performance Ratings preceded with an asterisk

Table below chart shows the Signature Manifest information

With Part 11 License

Batch

Unit Recipe

Batch

Unit Recipe

Page 72: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Gantt Chart

Without Part 11 License

Manually entered Performance Ratings Not preceded with an asterisk

No Signature Manifest Table

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Unit Recipe List

Signature Manifest icon

When clicked it calls up Signature Pop-up window containing Signature Manifest information

With Part 11 License

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Page 74Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Unit Recipe List

Without Part 11 License

No Signature Manifest icon

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Page 75Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Unit Recipe Property Sheet

Signature Manifest for manually entered unit recipe performance rating

With Part 11 License

Page 76: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 76Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Unit Recipe Property Sheet

Without Part 11 License

No Signature Manifest

Page 77: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 77Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Unit Utilization Chart

Manually entered Performance Ratings preceded with an asterisk

Table below chart shows the Signature Manifest information

With Part 11 License

Page 78: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 78Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Unit Utilization Chart

Without Part 11 License

Manually entered Performance Ratings Not preceded with an asterisk

No Signature Manifest Table

Page 79: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 79Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

BatchWeb Formula Item Impact

View

New Formula Item Formula Item Value

Esig Esig Icon

Esig Manifes

t

Esig Esig Icon

Esig Manifes

t

Formula Data EntryNew Item

X

Batch Formula X X X X

Formula Item Value Entry

X X

Formula Item Array X X

Page 80: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 80Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Formula Data Entry New Item

Electronic Signature required to add formula item

With Part 11 License

Page 81: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 81Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Formula Data Entry New Item

Without Part 11 License

Electronic SignatureNOT required to add formula item

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Formula

Manually created formula values

marked with Signature Manifest icon

Clicking Signature Manifest icon calls

upSignature Window

With Part 11 License

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Page 83Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Formula

Without Part 11 License

Manually created formula values NOT marked with Signature Manifest icon

Page 84: Yokogawa Electric Corporation Exaquantum/Batch Validation Planning Guide – Issue A Copyright © Yokogawa Electric Corporation 1 st Edition April 18, 2005

Page 84Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Formula Item Value Entry

Signature Manifest shows data for previous value change

Electronic Signature required to change value

With Part 11 License

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Page 85Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Formula Item Value Entry

Without Part 11 License

Electronic Signature Not required to change value

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Page 86Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Formula Item Array

Signature Manifest icon shows value was changed

Clicking on Signature Manifest icon calls up Signature window

With Part 11 License

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Page 87Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Formula Item Array

Without Part 11 License

No Signature Manifest icon for changed values

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Page 88Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Formula

Signature Manifest icon shows value was

changed

Signature Manifest icon shows formula item was manually created

With Part 11 License

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Page 89Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Batch Formula

Without Part 11 LicenseNo Signature Manifest

icon for changed values

No Signature Manifest icon for new formula items

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

BatchWeb Report Impact

Esig Check-out/in Disabled

Report Archive X

Report Approval X

Delete Report X

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Archive

Check-out and Check-in options not displayed

With Part 11 License

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Page 92Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Archive

Check-out and Check-in options displayed(based upon access rights)

Without Part 11 License

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Page 93Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Approval

Electronic Signature required to approve report

With Part 11 License

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Page 94Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Approval

Without Part 11 License

Electronic Signature NOT required

to approve reports

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Page 95Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Delete Report

Electronic Signature required to delete report

With Part 11 License

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Page 96Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Delete Report

Without Part 11 License

Electronic Signature NOT required

to delete reports

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Page 97Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Template Manager Report Impact

Esig

Report Approval X

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Template Approval

Electronic Signature required to Approve report template

With Part 11 License

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Page 99Copyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Report Template Approval

Without Part 11 License

Electronic Signature NOT required

to delete reports

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Yokogawa Electric Corporation

Exaquantum/Batch Validation Planning Guide – Issue ACopyright © Yokogawa Electric Corporation1st Edition April 18, 2005

Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

Industrial Automation Systems Division

CS Batch 3000 Configuration

for

Automatic Batch Data

Collection

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Exaquantum/Batch Validation Configuration Guidance(PM36J04B91-01E_001)

CS Batch 3000 Configuration for ABDC

Use the master recipe audit trail feature– Package PHS5170

Ensures all versions of master recipes are saved to Exaquantum/Batch– Without it some versions may not be collected during

Exaquantum/Batch downtime or during loss of communication– With the package CS Batch 3000 maintains a copy of every master

recipe version• Exaquantum/Batch will collect missed versions upon recovery of the

server or communications

Use “Automatic Management of Recipe Version” option on Recipe Group properties– Forces master recipe version to be incremented when built– Reduces confusion regarding Exaquantum/Batch revision based

upon date loaded to HIS and CS Batch 3000 Master Recipe Version field

• Without option turned on all Exaquantum/Batch revisions may have the same CS version number

– Even if they have different contents