General Specifications

Transcription

1 General Specifications LHS5170 Access Administrator Package (FDA:21 CFR Part 11 compliant) R3 GENERAL The Food and Drug Administration (FDA) issues 21 CFR Part 11 (Electronic Records; Electronic Signatures) for providing criteria of acceptance by FDA that electronic records and electronic signatures are equivalent to paper records and handwritten signatures executed on paper. This regulation enables to use of electronic technology for approvals. Two major functions are required to be FDA:21 CFR Part 11 compliant for control systems, which are the Access Control Functions and the Audit Trail Management Functions. Access Control Function (Personnel Authentication) To protect systems and data from any break-ins To control individual operations by authenticating an operator, a system engineer, a user of report package, and a recipe engineer Audit Trail Management Function Automatically record the history of Operation, Recipe Creation, Report Maintenance, and System Maintenance (When, Who, What, Where, Why, How?) Regarding CENTUM CS 3000, three major categories can be considered for 21 CFR Part 11 compliant : Operation and Monitoring Function (for operators); System View/Builder (for system engineers); Report Package (for report users); CS Batch 3000 Recipe Management Function (for recipe engineers). This GS covers 21 CFR Part 11 compliant of System View/Builder; CS Batch 3000 Recipe Management Function. In addition, operator management is included in the LHS1100 Standard Operation and Monitoring Function. Report User Management Recipe Engineer Management System Engineer Management PC Master Recipe Management PC PC Application Program Management Ethernet Operator Management Operation Management Control Recipe Management HIS HIS Console Type V net FCS Controller HIS: Human Interface Station FCS: Field Control Station Figure CENTUM CS 3000 System Configuration For details of FDA:21 CFR Part 11 compliant function in Report package, see Model LHS6530 Report Package (GS 33Q02Q40-31E). F01E.EPS Yokogawa Electric Corporation , Nakacho, Musashino-shi, Tokyo, Japan Tel.: Fax.: Copyright Sep.25,2001 4th Edition Sep.24,2003

2 2 FUNCTION SPECIFICATIONS Function Overview Engineer Authentication <Access Control> System View/ Recipe Management Start Start Audit Trail Management Viewer Builder Modification Record Detail Display (View Mode) Audit Trail Log Start Download Record Reference Modification Record Viewer Start Save Audit Trail Management Database Modification File Database Start General Text Editor Project <Audit Trail Management> F02E.EPS Sep.24,

3 3 An Example of System Configuration A recipe management function runs on CS Batch 3000 systems. Recipe Management Recipe Data (Master Recipe) Recipe Management Function Engineering Engineering Function Project Database V net Ethernet Save Restore Audit Trail Data Archived-PC Log Data Auxiliary Storage Device(*1) HIS Modification File Database FCS Audit Trail Save Audit Trail Reference *1: Tape or other removable media F03E.EPS Figure An Example of System Configuration One PC which is dedicated to the audit trail data must be prepared. Operation and Monitoring function, Recipe Management Function, and Engineering Function (etc.) cannot be installed in the PC. Additionally, a server PC is used to store audit trail data in some system configurations. It depends on the total number of PCs in which Builder Function or Recipe Management Package is installed. For details, see Integrated Production Control System CENTUM CS 3000 System Overview (GS 33Q01B10-31E). For the project with Recipe Management Function, the Audit Trail Management for Engineering Function and Recipe Management Function can be performed by only one PC with Audit Trail data-saved. System Administrator After the package is installed, various setting must be done to use Access Control Function and the Audit Trail Management Function. An engineer who actual performs Engineering cannot set them. Only system administrators can set these requirements. (A system administrator is any person authorized to administer PCs.) The roles of a system administrator and an engineer is shown below: System Administrator Network Administration Specify and edit the engineer security file Resister engineer name Setting the authority in each engineer group Specify and change the Audit Trail Management-database s location Start/Stop of Audit Trail Management Backup the data when the database of Audit Trail Management is full and delete the modification file. View the current records in the Audit Trail Management database.

4 4 Access Restriction Settings The following table lists the functions set by the system administrator. The table includes the required items in the LHS1100 Standard Operation and Monitoring Function and LHS6530 Report Package. In addition, access-control requirement functions are classified into the following four: A: User ID registration management handling of user IDs and passwords B: Access control setting conditions for accessing the system C: Password policy Password setting conditions, etc. D: Windows direct access PC desktop environment User group HIS group Engineering group (system builder, recipe builder, report builder) (*1) A B C D Set location Optional packages required Function Security builder (*2) HIS utility (each HIS) Not required (included in standard applications) Access control utility (each PC) LHS5170 packages for FDA 21CFR Part 11 User ID registration and deletion X (*3) X Authorization setting for each user ID X (*3) X Password management (Local control/common control) X Automatic user logoff /automatic screen lock X X Check illegal logon attempts X (*3) X User lockout (*4) X X User ID release during lockout (*4) X X Password resetting (*4) X X Reconfirmation with double authentication X (*3) Biometric authentication (fingerprint authentication) X Optional Check expiration date of passwords X (*3) Check obsolete passwords (*4) X X Check password-length (*4) X X Automatic logon Windows X (*3) X CENTUM desktop X (*3) X X *1: Report packages (PHS6530/LHS6530) are separately needed to perform report functions. *2: Registration and authorization of the engineer are needed as well as the system administrator authorization (PC administrator authorization) to operate the security builder. *3: The System administrator authorization is needed in revision R3.04 or later. *4: This is a new function of R3.04. T06E.EPS

5 5 System Engineer Management (System View/Builder) Access Control Can limit the access to the project-database for each system engineer. This enables to clearly define the separate roles. For instance, system engineer A can modify the drawing from one to ten of FCS0101. System engineer B cannot modify FCS data but can create, delete, and modify the graphic of entire HIS. Access Controllable Unit Access Control can be specified for each PC. Applicable Project of Access Control Access Control can perform on the default or the current project. It cannot perform on the user-defined project. System Engineer Group and System Engineer A system engineer group is a fundamental unit for specifying the authorities to perform engineering. All system engineers must belong to one of the groups and register the engineer name (ID); password; legal name. A system engineer can perform an engineering depending on the authority its group entitled. SYSTEM_GR GRAPHIC_GR A group for the graphic creator Cannot belong to multiple groups F04E.EPS Figure An Example of System Engineers and Groups The Scope of Authority The minimum unit for entitling authorities to a system engineer group is a builder unit as the graphic or the drawing. The Authority Types Read: Can read files. If only Read is entitled, cannot select Overwrite and Save or Download on Builder. Cannot create an engineer group without Read authority. Write: Can write into files. Can also Save and Download the existing files. Create: Can create and delete an object on System View. To create a station or to delete a window, need to be entitled this authority.

6 6 System Engineer Authentication and Authority Check This verifies identity and if the system engineer has the authority to perform the job. Table System Engineer Authentication and the Timing of Authority Check Timing Logging onto System View Creating and Deleting a project (etc.) on System View Starting Builder Overwriting and Saving in Builder (*1) Downloading in Builder (*1) Logging off from System View : Will be performed. : Not performed. Engineer Authentication (*2) (*3) Authority Check T01E.EPS *1: When starting up Builder, System View will check the authority for Write. If the engineer does not have the authority, it is started in Read Only mode, so this person actually will not be able to select the menu. *2: Will be checked if the builder is with download function. *3: Will be checked if the builder is without download function. Audit Trail Management The modified engineering data is automatically saved in the pre-defined database. Recording the Audit Trail Log simultaneously enables to view WHO; WHEN; WHAT; HOW; REASON; WHERE (the data is modified). Detailed information of WHAT and HOW can be viewed as well. Selecting the modification file and starting Builder in View mode enables to display the differences in various-colored (Note: Some of Builders cannot display the differences. For details, refer to the Table Builder View Mode Functions ). Audit Trail Management Policy (Recording Timing) The Audit Trail Management data is saved only when engineering that affects the product quality is performed (downloading to current machine). Simultaneously, the data is saved in the Audit Trail Log file. Applicable Project of Modified Data Save Modified data of default and current project is saved, but the engineering data of user-defined project will not be saved. Not Applicable Builder Fieldbus Tools, OPC

7 7 Project Hierarchy Project Common BATCH FCS Table Builder View Mode Functions (1/2) Builder Name Station Configuration System-fixed Status Character String Security Alarm Priority Alarm Processing Table Alarm Status Character String Block Status Character String Plant Hierarchy Engineering Unit Symbol Switch Position Label Multiple Project Connection Operation Mark Status Change Command Character String State Transition Matrix Process Management Configuration Unit Common Block Common Block Product Control Train FCS Constants Process Cell SEBOL SFC Sequence Unit Procedure IOM (other than Fieldbus) Fieldbus Communication Input/Output Global Switch Common Switch Communication Input/Output Tag Annunciator Signal Event Operator Guide Print Message Drawing Function Block Overview Function Block Detail Drawing/Logic Chart Status Display (option) Supported Functions Difference Display (*1) (*2) (*3) (*4) Other Functions Start Detail Start Detail : Supported : Partly supported : Not supported T02E.EPS *1: Cannot display the differences of the detailed setting information for each terminal. *2: Cannot display the differences of the block parameters of Fieldbus blocks. *3: Cannot display the differences of the details of each function block. *4: Cannot display the differences of the Sequence tables, General-purpose calculation formula, Logic chart, SFC, and SEBOL.

8 8 Project Hierarchy HIS STN Table Builder View Mode Functions (2/2) Builder Name Function Key Assignment Sequence Message Request HIS Constants Panel Set Scheduler Trend Acquisition Pen Assignment Graphic Help Taglist Builders (Operator Guide Message) Taglist Builders (Print Message) Taglist Builders (Sequence Message) Taglist Builders (Tag Name) Taglist Builders (Area Name) Supported Functions Difference Display Other Functions : Supported : Not supported T02-1E.EPS Recipe Engineer Management (Recipe Management) Access Control Can limit the access to create and modify Master Recipe for each recipe engineer. Access Controllable Unit Access Control can be specified for each PC. Applicable Project of Access Control Access Control can perform on all projects. Project attribute does not affect. Recipe Engineer Group and Recipe Engineer A recipe engineer group is a fundamental unit for specifying the authorities to operate recipe management functions. All recipe engineers must belong to one of the groups and register the recipe engineer name; password; and legal name. A recipe engineer can operate recipe management functions depending on the authority its group entitled. The Scope of Authority The maximum unit for entitling authorities to a recipe engineer group is a project, and the minimum unit is a recipe. The subgroup is not in the authority scope.

9 9 The Authority Types Read (*1): Can start Recipe Builder/Procedure Builder and view recipes. Recipe View and Builder are Read Only. Write: Can create and edit a recipe. Cannot delete and download a recipe. Delete: Cannot create; delete; edit a project and a recipe group. Can delete a recipe. Cannot download a recipe. Cannot create; delete; edit a project and a recipe group. Download: Can download recipes from Recipe View/Builder. Cannot create; delete; edit a project and a recipe group. Approve (future function): Can write in the recipe-approval person field. Cannot create; delete; edit a project and a recipe group. Engineering (*2): Can create; delete; edit a project and a recipe group. Can start Recipe Builder/Procedure Builder and view recipes. Cannot create; edit; delete; download a recipe. *1: All recipe engineers are automatically entitled Read authority and cannot set the authority scope. *2: Engineering authority can be used with Recipe-related authority (Read, Write, Delete, Download, and (Approve)). For instance, Engineering authority plus Download authority for one recipe engineer. Recipe Engineer Authentication and Authority Check This verifies identity and if the recipe engineer has the authority to perform the job. Table Recipe Engineer Authentication and the Timing of Authority Check Timing Logging onto Recipe View Creating and Deleting a project/ a recipe group on Recipe View Change of property Creating and Deleting a recipe on Recipe View Starting Builder Overwriting and Saving in Builder Downloading Logging off from Recipe View : Will be performed. : Not Performed. Recipe Engineer Authentication Authority Check T03E.EPS Audit Trail Management The modified recipe data is automatically saved in the pre-defined database. Recording the Audit Trail Log simultaneously enables to view WHO; WHEN; WHAT; HOW; REASON; WHERE (the data is modified). Detailed information of WHAT and HOW can be viewed as well. Selecting the modification file and starting Builder in View mode enables to display the differences in various-colored (Note: Some of Builders cannot display the differences. For details, refer to the Table Builder View Mode Functions). Audit Trail Management Policy (Recording Timing) The Audit Trail Management data is saved only when engineering that affects the product quality is performed (modifying recipe-related engineering definition or downloading recipe to recipe server). Simultaneously, the data is saved in the Audit Trail Log file. Applicable Project of Modified Data Save The modification file of all projects is saved. Table Builder View Mode Functions Project Hierarchy Recipe Recipe Builder Procedure Builder Builder Name Supported Functions Difference Display Other Functions : Supported : Not Supported T04E.EPS

10 10 OPERATING ENVIRONMENT Hardware requirements Supported Service Packs are the same as for LHS5100 Standard Builder Function operating environment. Recommend to prepare a PC with proper hard disk capacity (40 GB or larger) for Audit Trail database. Also prepare a device (for instance, DAT drive) for making backup of Audit Trail database. Software requirements Supported Service Packs are the same as for LHS5100 Standard Builder Function operating environment. Access Administrator Package (FDA:21 CFR Part 11 compliant) must be installed in the PC with LHS5100 Standard Builder Function or LHS5161 CS Batch 3000 Recipe Management Package. The package cannot be performed on the PC with only Graphic Builder installed that does not through System View and does not affect the project-database. MODELS AND SUFFIX CODES Model Suffix Codes LHS5170 Description Access Administrator Package (FDA:21 CFR Part 11 compliant) -S Basic Software License -C Multiple Software License (for 2 or more) 1 Always1 1 English version Note: LHS5110 Access Control Package is included in this package, so it is not required. T05E.EPS TRADEMARKS CENTUM is a registered trademark of Yokogawa Electric Corporation. Pentium is a registered trademark of Intel Corporation. Other product and company names appearing in this document are trademarks or registered trademarks of their respective holders. FOR THE SYSTEM OF R3.01 OR EARLIER VERSION The Recipe Builder Security Function (simplified function of Access Control) introduced in CS Batch 3000 Recipe Management Package (from R2.20 to R3.01) is now, in R3.02, included in Access Administrator Package (FDA:21 CFR Part 11 compliant). If Recipe Builder Security Function is used in the R3.01 (or earlier) system, re-engineering is required. Subject to change without notice.