Yokogawa Electric Corporation Copyright © Yokogawa Electric Corporation 21 CFR Part 11 Support for CS1000/3000

Yokogawa Electric Corporation

<ISD-MASP-S05025>Copyright © Yokogawa Electric Corporation<May 25, 2005>

21 CFR Part 11 Support for

CS1000/3000

Proprietary info goes here…Page.2


Yokogawa’s policy for 21CFR Part11 compliance is constructed based on FDA documents, and on discussion with our customers who have pharmaceutical plants.

In order for pharmaceutical plants to comply with 21CFRpart11, both of the following must be addressed.

• Technical point of view (with the functions of CS1000/CS3000)

• Management by procedure, I.e, SOP (Standard Operation Procedures)

We hope this presentation not only explains the technical points, but also helps to create your own SOP.

Scope

This presentation describes the 21CFR Part11 related functions of CENTUM CS1000, CS3000.



R3.02(Phase.1)

R3.03(Phase.2)

R3(Phase.0)

Support 21 CFR Part11

RXX (Phase.3)

Enhancement

•Security function of HIS, Builder•Audit trail of HIS

•Enhancement of HIS security function, such as the check of invalid access.

•The security function of Builder and that of recipe management with password & finger print.

•Audit trail of builder & recipe management.

•The security function and audit trail of reporting function.

•Integration of HIS historical messages.•Enhancement of the builder, recipe management security, such as automatic screen lock.

2001.12

2001.5

2003.1

Development Roadmap



Contents

FDA CFR Part11 requirement review.Typical system configuration.Software package overview.Function overview of CS 1000, CS 3000 to meet Part11 requirements.Summary of Part11 related functions.– For operation– For production engineering (Builder)– For recipe management– For reporting

Reference. (Display examples)



What is FDA 21CFR Part11 ?

The new regulation, issued by the FDA, for all computer systems related to the pharmaceutical production.– Not only for new systems, but also for the existing systems.

Many pharmaceutical providers are planning to introduce Part11 support system.

CS1000, CS3000 is the system which meets FDA 21CFR Part11.

Yokogawa had been investigating the detail of Part11 with several pharma customers together.



Basic requirement for Part11.

In order to manage electronic record data, production systems need

– to prevent data tampering.

– to guarantee data reliability.

Based on above, basic requirements are– Computer systems have to be capable of automatically

creating an audit trail independent from the users.

– System, data security and data integrity should be guaranteed by system access control.

– Detection and notification of invalid access.

– The mechanism to use electronic records at any time it is required.



Ethernet

HIS: Human Interface StationFCS:Field Control Station

Audit trail data server

E: System Administrator

- Data storage- Data search- Reporting

V net

ooo

ooo

ooo

FCS

HIS

A: Management of Operators. 1:　Management of Operators Audit trail DB

2:　Management of Operators (Reporting) Audit trail DB3:　Management of instrumentation engineers Audit trail DB4:　Manager of recipe management Audit trail DB

D:Management of recipe management

C: Management of instrumentation engineers.

•Access control •Audit trail

Reporting

PC

For System builder


For Recipe Management

Typical system configuration


For Reporting *


For HIS

•Access control •Audit trailFor the HIS in the field

B: Management of Operators.

•Management of the whole audit trail data in the overall system.

In the fieldHIS



Ethernet

Audit trail data server

E: System Administrator

HIS

A: Management of Operators.



Reporting

PC


Recipe builderSystem builder

(1) Access Administrator Package(FDA CFR Part11 compliance)

(2) Historical message integration pkg.(3) Standard Operation function(4) Standard Builder function(5) Reporting Package(6) Recipe Management Package(7) MS-EXCEL(8) Acrobat

Part11 related packages

(7) MS-EXCEL

(8) Acrobat

(1) Access Administrator Package

(2) Historical message integration pkg.

(3) Standard Operation function

(5) Reporting Package

(7) MS-EXCEL


(4) Standard Builder function

(1) Access Administrator Package (6) Recipe Management Package


Part11 related software packages



Functional overview of CS 1000/CS 3000 features to meet 21 CFR Part11

requirements.



In CS1000, CS3000 design policy, from the security point of view, was to classify people into 4 groups, based on their roles to access DCS.– Operators

• Operation and monitoring, Executing control recipes, Reporting, Generation of the report template.

– Instrumentation Engineers• Configuration work, such as creating control logics, sequence,

graphics, etc by using System builder.

– Recipe Engineers• Creating master recipes.

– System Administrators• Access control for all people who access DCS, Setting audit

trail, etc.

Security and classifying



Security functions (1/2)

Operator Authentication / Engineer Authentication– 2 entry items, User ID and password, are necessary for

authentication.

Check the valid Period of User Passwords.– System Administrator sets the valid period of user passwords.– On expiration, a dialog is displayed notifying that changing

the password is required.

Intrusion Counter– System counts the number of invalid intrusions.– If the number reaches the limit set by System administrator,

a System Alarm occurs on all HIS’s and is stored in the audit trail server.



Security functions (2/2)

Automatic User-Logout (HIS)– After a period set by System Administrator, no action

with keyboard or with mouse will automatically trigger a User-Logout action and the display screen is cleared.

Automatic screen lock (Builder, Recipe builder, Reporting)– After the period set by System Administrator, no action

with keyboard or with mouse will trigger the “Lock screen” action preventing user actions on any windows. To unlock, a password is required.

The management of disused user ID’s.– When an user ID becomes disused (ex. Quits the

company), the user ID is managed as “Disused User ID” instead of just deleting the ID. Disused User ID’s are not able to be used again.



Audit Trail

Actions are stored automatically in the Audit Trail Server with 5W1H (Who, What, When, Where, Why, and How) manner.The audit trail starts automatically when the system starts up, and keeps running continuously.



The management of System Administrator.– There is no function to protect against the illegal

access by System Administrator.– It is essential to manage with a SOP (Standard

Operation Procedure) based on the example below.

Example:Assign two people who have following roles respectively to have the difficulty to perform the invalid access.

System Administrator (The administrator for DCS users) who is responsible to register/delete user accounts.

IT maintenance administrator (Not a DCS user) who is responsible to maintain all PCs used in the DCS system.

Note for security policy (2/2)



HIS on field

HIS

Management of Operators

V net

ooo

ooo

ooo

FCS

Access control　 User ID + Password　 User ID + Finger print check Check the valid Period of User Passwords. Intrusion Counter Automatic user-out　 Double Authenticated Confirmation Dialog Box

Audit Trail　 Automatic recording with 5W1H manner.　 Eternal storage & Integrated management.Others　 Disused user ID management.

Ethernet

Management of Operation


For HIS

HIS: Human Interface StationFCS:Field Control Station



HIS in field

HIS

Ethernet

All operations (actions) on the HIS are stored in each HIS in an FIFO manner and are equalized among all HIS’s.

• The audit trail of all HIS’s can be handled in a single PC.

• Long-term storage. (Eternal)• Quick search.• Reporting the search result.

(PDF, Electric signature)

Therefore,Audit trail data server

Audit trail for operation

Storage & integrated management.



Management of Instrumentation engineering.

Access control　 - User ID + Password　 - Check the valid Period of User Passwords. - Intrusion Counter - Automatic lock-out

Audit Trail　 - Automatic recording with 5W1H manner.　 - Recorded audit can be displayed

on a dedicated viewer.

Others - Disused user ID management.



For System builder



Management of Recipe engineering.







For Recipe Management



Action range for reporting.

The Reporting Package

The reporting package of CS1000, CS3000 contains 2 major functions.– Generating the report template by a senior operator (manager)– Printing the report by a general operator

Depending on each role of manager or operator, they are included in each group and access control can be executed.

The Group “Manager”

The group “Operator”

Report printingGeneratingreport template



Management of generating templates





Reporting


For Reporting


HIS



Management of printing

There are 2 ways to print the report.– Output the report as PDF files. (Recommended)

• PDF files have stronger security.• It enables to need User ID and password.

– Output the report as XLS files.• It is necessary

– to make the audit trail function of MS-EXCEL start automatically

– to manage all report files with passwords– to store the Audit Trail Server as XLT files.



Case A:Because the reconsideration data need to be entered via HIS, the authentication function of HIS can be used.

Adobe Acrobat

HIS or PC AB

Stronger data security Electric signature with

User ID + Password

.xlt

LoggingDB

Printing log files DB

Audit Trailserver

.xlt.xlt

Case B:Make the audit trail function of MS-EXCEL start automatically, manage all report files with passwords, and store the Audit Trail Server with “xlt” files.

MS-EXCEL

PDF files

Entry reconsideration data

Management of printing



Appendix



User-in Dialog



WhoWhen WhereWhat WhyHow

Audit Trail (Historical Report)



Revised items are noted by color

Clarifying the revised items at configuration



Double Authenticated Confirmation Dialog Box



Warning Dialog for operation



Setting password related items

Preservation of invalid access

Notification of invalid access

Valid Period of User Passwords.

Intrusion Counter

Documents

Yokogawa Electric Corporation Copyright © Yokogawa Electric Corporation 21 CFR Part 11 Support for CS1000/3000