WO1997007443A1

WO1997007443A1 - Validation control system

Info

Publication number: WO1997007443A1
Application number: PCT/IE1995/000042
Authority: WO
Inventors: Edward Dornan
Original assignee: Dornan Research & Development Limited
Priority date: 1995-08-18
Filing date: 1995-08-18
Publication date: 1997-02-27
Also published as: AU3190395A

Abstract

A validation control system enables all steps in an industrial process to be monitored and data collected therefrom to be reviewed. The system includes a master validation routine which can not be altered except by specified authorised personnel. Likewise, process steps may not be varied by unauthorised persons. Any change made to the master validation routine or to any process step is logged and remains on the system in a read-only format. Reports may be drawn up on the system and viewed. The system can detect a fault in the validation system and generate an alarm which is transmitted to relevant personnel. Unauthorised access to or tampering with the system is prohibited. The system may interact with the process-controller to shut-down the process in the event of a critical error being detected by the system.

Description

VALIDATION CONTROL SYSTEM

The present invention relates to a validation control system.

Certain factory processes are used to manufacture products, the quality of which is required to meet standards set by national authorities. The environment and conditions under which the process is conducted can be a very important determining factor in the ultimate quality of the product of such process. One example of an industry in which careful process monitoring is mandatory is the pharmaceutical industry. Where mandatory or statutory controls on products, such as drugs, exist, it is normal that the relevant regulatory authorities be given access to plant records which enable the production history of any batch of product to be traced.

An object of the present invention is to provide a means for validating a particular process' requirements, for controlling process changes and for retaining a tamper-proof working process archive including records of any changes made in the process parameters.

Accordingly, the present invention provides a computer apparatus for validating a process control and operation system, the apparatus comprising means for preparing a process validation routine from inputted data, means for revising, approving and/or altering the routine, interface means for monitoring, collecting data from and directing the control system, means for storing the collected data in an information storage and revision area and means for retrieving inputted and collected data from the information storage and revision area. Preferably the process control and operation system is external to the apparatus, and includes means for preventing access to the process control and operation system except via the interface means following approval of the process validation routine by the approving means. Conveniently, means are included for preventing the control system from initiating the process pending approval of the process validation routine.

The apparatus may include means for storing process parameter data, means for comparing data collected by the interface means with the process parameter data and means for generating a fault report and/or for causing the control system to alter or shut-down the process when the collected data is not in compliance with the process parameter data.

The process validation means may include means for preparing the process validation routine including means for editing, revising, approving or post-approval changing any inputted or collected data, or any subset thereof.

Preferably, the apparatus includes means for limiting access to stored data or any subset thereof to specified authorised users, such means including means for according varying access-level privilege to different users, including read-only access, data edit or revision access, data approval access and post-approval process change access.

All inputted and collected data, including all data edits, revisions, approvals or post-approval process changes is preferably archived to a read-only memory.

The apparatus also includes means for periodically requiring an authorised user to alter his password for accessing stored data.

The means for preparing the process validation routine includes means for assigning each step of the routine a pre-requisite status within the overall routine and means for enabling the approval of any step only when all preceding pre-requisite steps in the routine have been approved. The routine may be displayed and the position of any step in the routine according to its position in the approval sequence may be shown.

The invention also provides a method for validating a process control and operation system, the method comprising preparing a process validation routine from inputted data, revising, approving and/or altering the routine, monitoring, collecting data from and/or directing the control system, storing the collected data in an information storage and revision area and retrieving inputted and collected data from the information storage and revision area. Conveniently, the process control and operation system is external to the apparatus.

The method includes restricting access to the process control and operation system following approval of the process validation routine and preventing the control system from initiating the process pending approval of the process validation routine.

The method includes storing process parameter data, comparing collected data with the process parameter data and generating a fault report and/or causing the control system to alter or shut-down the process when the collected data is not in compliance with the process parameter data. Preparing the process validation routine includes editing, revising, approving or post-approval changing any inputted or collected data, or any subset thereof. The method also includes access to stored data or any subset thereof to specified authorised users, including according varying access-level privilege to different users, including read-only access, data edit or revision access, data approval access and post-approval process change access.

In the method, all inputted and collected data, including all data edits, revisions, approvals or post-approval process changes is archived to a read-only memory. An authorised user is periodically required to alter his password for accessing stored data.

Preparing the process validation routine further includes assigning each step of the routine a pre-requisite status within the overall routine and enabling the approval of any step only when all preceding pre-requisite steps in the routine have been approved and may include displaying the routine and showing the position of any step in the routine according to its position in the approval sequence.

General Description of User Requirements:

The system is a validation control system with particular focus on file and quality control. It has a built in file editor, to allow editing of files such as a Validation Master Plan (i.e. VMP) . The files have editing access restrictions and the system logs changes to the log file. The system can maintain version control on all files. It is primarily run on WINDOWS and is written in a language that can be complied on many other platforms such as Apple Mac, UNIX, and DOS. The package is compatible with any database types to allow communication with any other packages. It is very user friendly and has good response times. The package is Network ready and allows for an E-mail connection in addition to having an internal mailing system. The system has a very high level of security built into it.

The system package is essentially a validation file control system and allows easy creation of a Validation Master Plan and all associated documentation i.e. User requirement specifications (URS); Architectural design specifications (ADS) and system acceptance tests (SAT) etc. All files are controlled by a document revision system. The files can conform to relevant standards i.e. ISO 9000, BS5750 and FDA. Documentation must be easily accessible and printable.

The system has the following functions:

(a) Project setup

(b) Edit file setup

(c) Fault reports

(d) Revise file

(e) Approve file (f) Change Control - Project

- File

- Process Control/System

- Process/Plant

- Other (g) View file

(h) Print report of current screen

(i) Print setup

(j) Standard windows edit menu options

(k) Test log, fault report log, change control log, completed projects/files and project tree reports (1) User reports (additional reports customised for particular user) (m) User setup. Group setup (n) Log file browse (o) Options like Beep, Clock, Change password, and fax file/fax list setup (p) Help (q) About (Copyright information screen) .

Specific User Requirements: (1 ) User Requirement UR0001

The system has a user Id and password screen for protection against unauthorized access. The user Id must accordingly be attached to files both on screen and on printed hard copies. The system administrator will determine the type of access allocated to each user Id. The following are exemplary access levels in-built into the system; Administrative, Co-ordinator, Approval, Test personnel; Technical author and Read-only. This will be described in more detail below.

Main Menu Options:

The following is a list of the options which appear in the main menu of the system: File, View, Print, Edit, Reports, Administration, Options, Help.

The "File" option gives the following selection:

(a) Setup of project information in database, including module setup, file type setup, project users, signatories, files and pre-requisites. (b) Open a project file for editing. (c) Set file as completed and give it a revision number .

(d) Set the last revision back to a working copy.

(e) Approve a revision as a completed file.

(f) Change control for project, file, software and/or process plant.

(g) Edit for the system, (h) Close.

The "View" option gives the following:

(a) File (may be a hard processing file, spreadsheet, CAD drawing etc) .

The "Print" option gives the following selection:

(a) List/All

(b) Printer setup

The "Edit" option gives the following selection:

(a) Undo - revert the most recent change since the file was last saved

(b) Redo - revert the most recent Undo

(c) Cut - move a block of text to the clipboard (d) Copy - copy a block of text to the clipboard

(e) Paste - copy contents of the clipboard to current cursor position

(f) Select All - mark all text for cut/copy or delete

(g) Find - search for first instance of a string in the file

(h) Find Again - search for next instance of same string in the file (i) Replace and Find Again - similar to Find and

Find Again except replacing the string with another (j) Replace All - replace all instances of one string with another string in the file.

The "Report" option gives the following selection:

(a) User Reports (User can make up required reports)

(b) Change Control Log

(c) Test Case Log

(d) Fault Report Log (e) List of Projects/Files completed (f) Project Tree

The "Administration" Option gives the following selection:

(a) User Id setup. Group setup

(b) Security

(c) Log File

(d) House Keeping (e) Customise

The "Options" option gives the following selection:

(a) Beep On/off (b) Clock

(c) Calendar/diary

(d) Calculator

(e) Filer

(f) Fax/E-mail

The "Help" option gives the following selection:

(a) Help

(b) About On the opening view screen a list of projects is displayed. There is a "New" push button to make a new project and project number and project name edit boxes. Edit boxes are enabled for input when the "new" button is pressed and the new project is saved to database when the project number and project name are entered. There are three list-boxes on screen. The first displays the project numbers and corresponding names in the system. The second displays a list of the files in a selected project. For any file selected, the corresponding approval pre-requisites are listed in a third list-box. The selected project will invoke access to that project only for the remainder of the session unless other project is subsequently selected. However, the user must be an authorised project co-ordinator for the selected project to be able to gain entry to project set-up from this screen. The initial view screen displays all projects, displaying project name, project number and a list of the files associated with each project and their completion status. The status information may be:

(a) Blank - File created but no information has been entered

(b) Edit - This file is being edited i.e. working version

(c) Revised - This file is completed and is awaiting

Revision approval

(d) Approved - This file has been approved and given a revision number.

The project number can be a unique identifier for that validation project. The user may open a selected file for editing if the user has the correct access level and the file is in a working revision. (2) User Requirement UR0002

Project Setup:

This calls up a project/file status screen.

Project File Status:

The following information may be entered into the database regarding each project:

(a) Project number (b) Project name.

A user can call up the selected project from the project list-box to enter the project setup screenset for that project.

The project screenset has a set of tabbed folder-look sub-screens for modules, signatory template setup, file types, project uses, files and pre-requisites. Once a project is set up, a validation master plan file is generated in the database as a word processing file.

The system has an inherent system of numerical identification for all validation files. The numbering system discussed herein is typical of a validation project but is not mandatory. The system will ensure that all files forming part of a validation project will be identified by a unique number.

The system will allow the user to select and numerically identify all the files contained within a validation project, and will also allow pre-requisites for the approval of significant files or completion of certain protocols.

A project may be setup in modular form, each area of control being identified as an individual module in terms of a validation project. Projects may contain a general module. Each module has protocol areas assigned to it, and the facility for an individual validation plan rational file.

On the project setup screen the project to hand is assigned a

(i) Project number; and (ii) Project name.

Each sub-validation plan will effectively be a sub-probject and can be setup as a normal project.

Modules sub-screen:

Each module is then given the following:

(i) Identifier number; and (ii) Name.

This screen includes a capability which enables module identifier and module name edit boxes to be input. Once entered, the new module is added to the project. There is also a modules list box to list all module identifiers and name in the selected project.

Signatory Template Setup sub-screen:

Signatory templates are associated with file numbers in a project. Individual users or groups may be added to or removed from signatory templates for revision, approval, or test data. Thus, there are list-boxes for groups, users and signatories, and add buttons for revision/approval/ test data signatories as well as a "remove signatory" capability. There is a list-box for signatory templates from which a template may be selected for modification. New templates may be added via "new" push button. When this button is pressed, a template name edit box is enabled for input; once entered the template is added to the database. A template may then be selected in the file sub-screen and applied to a set of file numbers.

File Types sub-screen: There is another sub-screen in project setup for file types, descriptions and categories. This screen includes a listing of all file types and a listing of project specific file types, descriptions and categories. New file types may be added with a "new" push-button for the selected project. These will be added to both list-boxes. There are add/remove buttons to move file types or copy file types and descriptions between both listings.

Project users sub-screen: This screen has list-boxes for users and groups which may be added to project users list-box via push buttons for adding co-ordinator/read-write/read only access. Project users may be removed via remove push button. This screen can be used to control access of users and groups of users to particular projects.

Files sub-screen:

This screen has a list-box for project file types, a list box for file numbers in a selected project, add buttons for adding file numbers for particular qualification areas, and a remove button to remove files. Each file is assigned a number and the user will be required to name the files. Files must be categorised by file type, e.g. word processor/spreadsheet/cad drawing etc. A list-box of file-type templates is available to allow automatic selection of a pre-defined or customer created template when a file is opened for first edit.

Pre-requisites sub-screen:

On selection, each file must be assigned pre-requisite files for the approval. By use of the files in each area, pre-requisites for all the files within any validation project can be set. The file lists in each area will increase in size as more files are selected for each module. There will be a minimum pre-requisite of the VMP being approved if there are no other file pre-requisites for a particular file.

The same procedure applies for design, installation, operation and process qualification protocols. Thus, the validation system enables a project to be set up in a cascade arrangement and ensures that no step in the cascade sequence may be approved until all the pre-requisite steps above it in the cascade have been approved. In this way, any occurrence of irreconcilable system loops is avoided.

Templates: Front sheet and file templates are setup for all files in the system. The format of a file front sheet is such that it contains the requisite number of approval boxes. The positioning of file control boxes and their heading names must be specified by the user. Files that are not approved are stamped with "for approval", otherwise

"approved". Obsolete revisions are stamped "superseded" or "withdrawn".

Automatic Generation of Validation Master Plan When a project setup is initiated, the validation master plan option is automatically created. This option cross checks all project information and issues warning messages if any aspect of the setup is incomplete, e.g. signatories or templates have not been setup. The validation master plan will be different for each project depending on the information and files specified in the project setup screen. Information regarding project setup and other database tables may be inserted into the validation master plan.

The system will prohibit the approval of any subsequent validation files without its being approved for the Validation Master Plan and other pre-requisite files. On completion of the project, a validation report can be produced and this will contain certain database information for inclusion as summary data.

File/Edit File:

A wildcard find utility allows users to select a specific file number. The file type of the file number will define a third party product being linked to. The file is then opened for editing unless the user does not have the required access. The pre-specified template will be the format of that file. All files are encrypted by the system; files are deciphered only if the user has the required access. The user may also use the file manager to perform the system functions in the wordprocessor (or spreadsheet package/cad package etc.) without always having to go directly through the system to the word-processor, e.g. revision/approval. Additional file manager functions available are reporting and file referencing.

Test Protocol Files: All test protocols will require a preamble and rationale for the purpose of the test. This text may be stored in a database, so as to allow it to be included in other similar test protocols. Test protocols may be created and executed in either the users wordprocessor via Dynamic Data Exchange (DDE) or in the system itself. The actual tests will be written into a database and converted into a tubular form on the test protocol. When this file is at a point where it is ready for approval for testing, a transmittal is sent to the appropriate personnel. When the required signatures are received, the protocol is approved and testing may commence.

When testing is complete the results will be entered into the database. The results will be in the form of "Pass" or "Fail", with comments as necessary. If a test fails then the system will generate a fault report. When the fault report is approved a re-test is allowed and the results of the re-test are entered. If a fault continues to register it may be cleared, but a record of this is logged. When all tests are complete the system issues a certificate of compliance that must be signed by the relevant authorised personnel. This will then allow the test protocol summary to be generated and the test protocol file frozen.

The system can incorporate the test results and allow a conclusion to be added to the test protocol summary.

All files will have a number of pre-requisite specifications that must be approved before the test protocol may receive approval.

If the system detects a fault in a critical instrument or at a critical or important step in the process being controlled, it has the capability to shut the process down (subject to safety criteria) until the fault is corrected. In addition to generating a fault report and transmitting this to the relevant personnel, the system may itself seek and suggest a remedy for the fault in appropriate cases. Once a suitable remedy has been selected and approved by the authorised personnel, the system will allow the process to be restarted. A full record of the fault and its correction history will be retained in read-only format for validation audit by internal or external regulators.

File/Fault Reports:

Fault reports previously issued for failed tests may be accessed using this option. The fault report can be customised for the particular project. Only users or groups on the access list may access the fault report, and to do so must verify their user Id and password.

Transmittals: Transmittals are setup by category, each category having a suggested circulation list. This list may be modified and included on the transmittal file list.

Certain categories of transmittal files will be generated by the system during the performance of the validation project. Other categories of transmittal files may be generated by the user.

There is a standard transmittal file supplied by the system but this may be changed by the client.

The system will record the following information for each transmittal:

(i) Names of personnel issued with the transmittal (ii) The reason for issue

(iii) Revision of the file

(iv) Unique transmittal number

(v) Date

Document Revision:

As any file is edited, the system will maintain an unrevised working copy. All edits to this document are recorded in the log file. These records show the name of the editor and the date and time the file was edited.

This file may be issued for revision when all editing is complete. This will freeze the current working revision and issue the next revision with its incremented revision number or letter.

File Revision and Un-Revision:

The file un-revision menu option allows the user to reset the present controlled revision back to a working version, optionally requiring an authorisation signature.

File Approval:

The file approval menu option allows the user to authorise a present controlled revision. Once a file is approved, further editing is only possible under the change control procedure. Approval and change control are linked in the system. All externals including process control programs, process/plant documentation and project are controlled by and may only be accessed via the system.

File Change Control:

When a file has been approved, editing is only possible by utilizing change control procedures.

Change control notices may be generated by use of the change control option. A change may not be carried out until all relevant authorities have approved the change. Once the change control notice has been approved, the system will unfreeze the relevant document for editing in a new revision. When the required modification is complete, the change control notice must be signed off by all authorised personnel, detailing any pertinent information as required. Finally, then the change control notice is approved, this will automatically update the revision and freeze the document.

File/Change Control/Pro ect:

Once a validation master plant is approved, the project change control must be used to re-open the project or file for editing. Other change control loop options are available for software and process plant. Any change control loop requested by a customer can be implemented.

File/Change Control/Process Control System and/or Process Plant: The change control forms will be specified by the customer. A change control may be originated, confirmed, approved and actioned (complete change control loop) by users of the system.

(3) User Requirement UR0003 View Document: The View option must allow the following

(a) View a file, e.g. a CAD drawing, a document, a process control system program.

View file:

The view file option allows the user to view any document within a selected project in a page by page format. In this option, all revision controls, headers and footers are displayed. If the file has a revision history, it will be possible to view each revision.

(4) User Requirement UR0004 The print option allows the following:

(a) Print the list of files on the system

(b) Print a list of all projects/files on the system (c) Adjustment of printer setup, i.e., which printer, landscape or portrait, resolution.

List:

On selection, the system will print the list of files with the current status of each.

All:

On selection, the system will print the list of all projects/files with the current status on each.

Printer Setup:

On selection, a screen for adjusting printer setup is displayed.

(5) User Requirement UR0005

The Edit option provides the following functions for editing text fields where applicable:

(a) Undo - revert the most recent change since the document was last saved.

(b) Redo - revert the most recent Undo (c) Cut - move a block of text to the clipboard (d) Copy - copy a block of text to the clipboard

(e) Paste - copy contents of the clipboard to current cursor position

(f) Select All - mark all text for cut/copy or delete

(g) Find - search for first instance of a string in the file

(h) Find Again - search for next instance of same string in the document (i) Replace and Find Again - similar to Find and

Find Again except replacing the string with another (j) Replace All - replace all instances of one string with another string in the document.

Blocks can be marked by dragging the mouse.

(6) User Requirement UR0006

This Report option provides the following management reports:

(a) User Reports - user can make up customised reports on the system databases

(b) Change Control Log (c) Test Case Log

(d) Fault Report Log

(e) List of Projects/Files completed

(f) Project Tree

Project Tree:

An example of a project tree is shown in Figure 1.

Project Tree is created by the system from the document hierarchy as set up via pre-requisites in Project Setup. It provides the facility whereby the position of any file in the project cascade may be seen in overview.

All reports may be viewed on screen and are printable.

(7) User Requirement UR0007:

The Administration option allows the following functions:

(a) Read/Write access to user Id information and passwords

(b) Read/Write access to group Id information

(c) Browse and Print facility for log file. The log file will list all previous transactions in the system (d) House-keeping to tidy files.

Users

On selection, a list of user Id's, user names, and privileges appear on screen. This list is scrollable. There are push buttons for:

(a) setting up New users

(b) updating existing user details (Edit)

(c) delete user Id (d) closing the current screen and returning to the main menu.

The New and Edit selections present a screen of the same format except that New has empty details in the screen while Edit edits the details of the user under the scroll bar of the selection list screen.

On the User setup screen (invoked by New or Edit push buttons on previous screen) as above, there are changeable fields for user Id, user name, user privilege and curriculum vitae. The latter detail is provided to enable regulatory and other authorities to ensure that users possess the required qualifications and training to support their access to the system. The user privilege field comprises a list box with the following options:

(a) Administrative

(b) Co-ordinator

(c) Approval

(d) Test personnel

(e) Technical Author

(f⁾ Read only

These options may be customised.

These privileges determine the type of main menu the user will see or be able to use on sign-on.

Also provided are push buttons for updating details to database (Save), and cancelling changes and returning to previous screen (Cancel). Users may be added to user groups for required job-titles and departments in the groups database. Once updated, user information will update groups information automatically.

Group Setup:

New groups of authorised personnel may be created or existing groups may be edited. Users may be added to or deleted from a selected group. New groups may be created using the "New" selection. Sub-groups may also be created.

Loq File:

On selection, the user may browse through the log file of the system. The log file is the list of transactions invoked by the system. Therefore, the system writes to the log file every time a transaction is performed to provide an audit trail of validation and quality control activities.

(8) User Requirement UR0008

The "Options" function provides the following capabilities:

(a) Toggle Beep between on and off

(b) Select 12 hour/24 hour clock or no clock

(c) Change user password

(d) Fax a particular project/document or setup fax number list.

Beep On/Off:

On selection, the system toggles Beep and return to the main menu. The system beeps (if on) when the user attempts to type on a forbidden area or overplays the keyboard.

Clock:

On selection, the user can select between 12 hour clock, 24 hour clock, and no clock. The clock, if selected should appear on the screen.

Change Password:

On selection, a screen displays the user's user Id, name, and old password. The user may enter a new password and verify it. For enhanced access security, the system may be setup to require users to change their passwords at preselected time intervals.

Fax: On selection, this option provides the user the choice of faxing a project/document.

(9) User Requirement UR0010

The "Help" option provides the following functions:

(a) a help facility

(b) an about screen showing the company logo, copyright, patent, and user rights.

Help:

On selection, this option presents a typical Microsoft Windows style help facility with push buttons for Contents, Search, Back and History.

About:

On selection, the information screen can be viewed. Pressing Enter returns the system to its main menu.

The system of the invention is designed to stand in front of an existing process controller computer, so the controller can be accessed only via the system. The system not only records the actions taken to change process parameters in any way, but also interacts with the controller program to direct actively the process controller. The system therefore provides for validation of a new or altered process and for maintaining a tamper-proof validation audit trail which is available for checking by authorities such as national licensing bodies. Access to or editing of stored files is restricted to authorised personnel by the use of acceptable encryption codes and the revision history of all files is mandatorily retained in read-only format for inspection.

Process control files are generated from within the system from the "Project Setup" screen set. The files are identified within particular projects by the assigned acronym. The creation of the file is achieved by allocating a file the assigned acronym within the project from "Project Setup". This will automatically allocate a file reference for the chosen acronym software file.

The file type is determined upon the creation of a new file within a project. Where a file is not a Word document there are a number of options for the file type reference. The required files are created within the system from the "Project Setup" screen set.

The process control files are created with a "Read-Only" file attribute which can only be revoked when the file is accessed from with the system when the project status dictates that the file is available for edit. When the file is selected from the "Project/Document Listing" screen after being created from the "Project Setup" screen, the programming application for the file, for example a RealTime Vision file is opened with the file which has been allocated by the system. All the functions and facilities of the application are available from this point, including the import of information from, and the editing and saving of other RealTime Vision files. At the conclusion of the editing session the file under the control of the system is saved and the "Read-Only" attribute automatically restored.

Files which are under the control of the system cannot be opened within any application outside of the control of the system as the Read-Only attributes render them inaccessible to the programming environment. For example, a file which was available for edit within the confines of the system cannot be accessed directly from the programming application. Where a file is already approved, or where a system User does not have the requisite authority or privilege, file access for editing is denied and any attempt to access the file from the "Project/Document Listing" screen results in the generation of a message to this effect. The programming application will not open and the system remains at the "Project/Document Listing" screen.

The system is designed to incorporate customer-driven alternatives to the delivered format of a change control form without having to change the system's code set. New formats of change control forms may simply be added to the system database by the supplier without changing the system's core programming.

A fuller understanding of the system may be gained by reference to the accompanying figures in which:

Figure 1 is a sample project tree generated by the system;

Figure 2 is an overview flow chart demonstrating the interlinked features of the system of the invention;

Figure 3 is an overview flow chart showing the system file control flow;

Figure 4 is a flow chart of the data management aspect of the system;

Figure 5 is a flow chart showing how the system encryptes and deciphers electronic files under its control;

Figure 6 is a flow chart showing how the system records for audit; Figure 7 is a flow chart showing the interfacing between the system and the process control computer and showing how a process parameter table is created or edited; and

Figure 8 is a flow chart showing how an established process parameter table monitors the production process.

The numbering system employed in the boxes in the figures represents the texts as follows:-

FIGURE 1

1.1 - EXAMPLE/G/VP/VMP/1

1.2 - EXAMPLE/G/DQ/URS/1/0

1.3 - EXAMPLE/G/IQ/HBS/1/0

1.4 - EXAMPLE/1/OQ/SAT/2/0

1.5 - EXAMPLE/2/OQ/SAT/2/0

1.6 - EXAMPLE/G/DQ/SOP/1/0

1.7 - EXAMPLE/G/DQ/EOP/1/0

1.8 - EXAMPLE/G/DQ/FDS/1/0

1.9 - EXAMPLE/G/lQ/lLC/1/0

1.10 - EXAMPLE/G/OQ/SAT/1/0

FIGURE 2

2 . 1 - CompuVal Login

2 . 2 - Record Test Results - 27/1-

2.3 - Pass/Fail (with automatic fault report) *1

2.4 - Project/Document Listing

2.5 - Document Selection

2.6 - Project Selection

2.7 - Create File

2.8 - Edit File *2 *3

2.9 - Sign-off

2.10 - View Previous Revision

2.11 - Revise *1 *4

2.12 - Approve *1 *5 *6

2.13 - Change Control *4 *6

2.14 - Project

2.15 - File

2.16 - Process Control System

2.17 - Process/Plant

2.18 - Project Setup

2.19 - Document Types - 27/2-

2.20 - Document Numbers

2.21 - Prerequisites

2.22 - Project Access

2.23 - Signatories

2.24 - Modules

2.25 - View Cad Drawing

2.26 - Redline CAD Drawing

2.27 - Reports

2.28 - Print

2.29 - Automatic User Reports

2.30 - Automatic Project Tree

2.31 - Options

2.32 - Calculator

2.33 - Fax File

2.34 - Change Password

2.35 - Calender/Diary

2.36 - Online Help

2 . 37 - Admin Functions _ 27/3-

2.38 - Setup Users

2.39 - Setup Groups

2.40 - Active Connections

2.41 - Automatic Logfile for Audit Trail

FIGURE 3

3.1 - Start

3.2 - Identify requirement for process control system file

3.3 - Automatically creates file number and empty process control file location within appropriate application

3.4 - Identify requirement to edit process control system file

3.5 - Opens encrypted application process control file, decrypts into application acceptable form for editing

3.6 - Process control file can be edited within application

3.7 - Is file at significant stage of development for revision/approval?

3.8 - Process control file is saved and encrypted into another file location - 27/4-

3.9 - Identify requirement to apply signature to process control system file

3.10 - Encapsulate electronic signature and apply within encrypted process control file

3.11 - Is signatory being applied for revision or approval purposes?

3.12 - Revision. A new copy of the process control file is created, the superseded revision is saved into a Read-Only archive

3.13 - Approval. Present copy of process control file is "frozen" into a Read-Only format that can only be released on instigation of a change control procedure

3.14 - Change Control Procedure. Approved process control file is identified as requiring further editing

3.15 - Change control form is automatically generated by CompuVal, with unique numerical identification and reference link to the process control file requiring change

3.16 - The changes that are required are recorded, and the necessary approval signatures are required to be entered to approve the process control file change

3.17 - The process control file is released for edit purposes when the necessary change has been approved - 27/5-

FIGURE 4

4.1 - Process Parameters Monitoring

4 . 2

CompuVal Process Event Log-File

Tag. Alarm Time/ Batch No. Type Date Number Result

TT High 10:15 BMP Batch Lost 0562 Temp. 11/3/95 12973

LIC LowLow 14:27 BMP Batch Held 9087 Level 23/4/95 13243 for Anal.

FIC Low 01 :23 BMP Batch Lost 3437 Flow 30/4/95 12988

AT High 20:06 BMP Batch Held 6749 Concentrate 4/5/95 13005 for Anal.

PT High 15:01 BMP Solut. Avail 5639 Pressure . 22/5/95 13266 for Batch

4.3

CompuVal Control Software Change Control Log

Control Change File No. User Name Date/Time CCN No.

S12453ST.S5D Jeff McBride 12:20 1001/2 11/5/95

S100342ST.S5D Dale Duggan 09:50 1001/4 17/5/95

S100345ST.S5D John Coleman 15:27 1001/12 23/5/95

S1003563ST.S5D Brian McAuliff 16:02 1001/18 24/5/95

4 . 4 Control Software File Check- in/Check-out - 27/6 -

Encryption Audit Trail

4.5 Change Control Form Critical Parameter Table Approval Information/Authority Audit Trail Date/Time

4 . 6 - Critical Process Parameter Comparison Table

Approved Value Measured Value

10W 10W

28°C 28°C

100 psi 100 psi

25 m3Hr 25 m3Hr

55% 55%

450 barg 450 barg

90% 90% etc. etc.

4.7 Process parameters are monitored against the approved list of parameters contained within the databases for any critical discrepancies

4.8 Control System Software provides link from Process Plant to the system

FIGURE 5

5.1 - New file to be controlled by CompuVal

5.2 Encrypt file so that no application other than CompuVal can access file

5 . 3 - CompuVal request to view or update file . e . g . Word/Excel/Lotus 1 23/CAD/PLC-DCS program, etc , - 27/7 -

5.4 - Approved?

5.5 - Being Approved or Revised?

5.6 Superseded revision?

5.7 - Has user read-only or read-write or co-ordinator access to file?

5.8 - Access denied to user

5.9 - Decipher file for viewing for current user only

5.10 - Has user read-write or co-ordinator access to file?

5.11 - Decipher file for updating for current user only

FIGURE 6

6.1 - Start Process

6.2 - Control system confirmation that process has started successfully is received?

6.3 - Process cannot start, record this fact for audit trail. Wait for new menu option selection

6.4 - Initialise entry-by-entry comparison of process parameter table

6.5 - Process parameter is within permitted range? - 27/8-

6.6 - Record time/date measured variable parameter and all pertinent detail of failed comparison to audit log-file

6.7 - Obtain details of failure path in regard to parameter/process details and pass to control system

6.8 - Record time/date of data transfer to archive

6.9 - Integrate comparison process to next table entry

6.10 - Increment is beyond last entry in process parameter table?

6.11 - Has process batch reached completion?

6.12 - Record time/date of completed comparison to archive

6.13 - Record time/date, process batch completion to audit log-file

6.14 - Wait for new process start command, or selection of other menu option.

FIGURE 7

7.1 - Log-on to CompuVal

7.2 - Checks for mail messages, validation activities, etc. are performed, links to other applications are established.

7.3 - Is CompuVal required for purposes of _ 27 /9-

entering/editing process parameter?

7.4 - CompuVal is required for other purposes, wait for new menu option set-up

7.5 - Does process parameter table exist

7.6 - Process parameter tables must be subject to change control before any edit can be enabled

7.7 - Process parameter table can be entered or imported

7.8 - Define process and number of entries required for parameter table. Create description, engineering units and range for each entry field

7.9 - Define process table links to control system for all table entry fields, define approval signatory template

7.10 - Signatory template is created as part of validation project set-up

7.11 - Process parameter tables are required to be approved, circulation of notice to this effect is required

7.12 - Obtain approval electronic signature

7.13 - Is User ID and Password applicable as a signature for purposes of approval?

7.14 - Is Signature cycle for approval complete? - 27/1 &-

7.15 - Are process parameter tables complete and approved?

7.16 - Make required edits to table entries and/or process parameter links

FIGURE 8

8.1 - Log-on to CompuVal

8.2 - Checks for mail messages, validation activities, etc. are performed, links to other applications are established

8.3 - Is CompuVal required for the purposes of editing approved process parameter table?

8.4 - CompuVal is required for other purposes, wait for new menu option selection

8.5 - Create new change request form, including current User as originator, detailing process parameter requiring change

8.6 - Change control forms are given a unique numerical identified on origination, signatory template is obtained from approval signatory template for parameter table

8.7 - Obtain approval electronic signature for change

8.8 - Is User ID and Password applicable as a signature for purposes of approval? 27/11

8.9 - Is signature cycle for approval complete?

8.10 - Process parameter table is revised, old revision remains Read-only, new revision is available for edit.

Referring to the figures, Figure 1 is a sample project tree showing each pre-requisite step which must be approved before the next step may be approved. Figure 2 shows the various available system functions from login outward to recording test results, document and file creation and editing and project setup, document revision and approval, process change control, reports, and other system capabilities. The numerals appearing in some of the feature boxes in the figure indicate as follows:-

*1 - feature includes electronic signature and E-mail function;

*2 - capability available to only the project authorised user, subject to document not yet being approved;

*3 - deciphers file before edit, encrypts file after edit;

*4 - encrypts file;

*5 - document has read-only status, even for project authorised users; - 28 -

*6 - automatic link between approval and change control.

Figure 3 shows the file flow control in the system and Figure 4 is an example showing how data is managed in the system and at the interface between the system and the factory process it controls. Critical process parameters are constantly monitored and checked against the control parameters. When a discrepancy occurs, the system makes a controlled series of changes in regard to the process control software to ensure a product-safe alteration. All the discrepancies noted and changes made are recorded to archive for the system's audit trail. Any alteration to the critical parameter list held on the system must be conducted in a controlled manner, with details of all changes being recorded for the audit trail. Additionally, the system allows changes to be made at a time during the process which is safe and convenient. The encryption/deciphering in the system is shown in Figure 5. Files are encrypted using any suitable powerful encryption system such as the RSA algorithm, which is acceptable to the United States Food and Drug Administration.

Referring to Figure 6, where the process monitoring facilities are utilised, the validated process parameter table is constantly referred to by the system. Each successful scan of the table without detection of any product affecting error is recorded until the completion of the product batch, or in cases of detection of a product affecting error, the time and date of all relevant information is recorded. All the process parameter monitoring is performed in a controlled and validated environment and all significant transactions are recorded.

Figure 7 shows the system interfacing module decision _ 29 -

making process in terms of the use of the interface for purposes of the monitoring of the process. This process will determine whether the validated parameter list which is seen to be critical to the particular production process has been created and approved within the controlled environment of the system. Unless this is the case, then the process is prohibited from starting. Where the process parameters have been determined and the created list approved, the act of requesting the process to start is recorded onto the chronological data file contained within the system. Where the process parameter table does not exist, or has not been approved for use, the system allows for the creation or editing of the table. No parameter table can be utilised until approved, and until the table is approved the process associated with the table cannot be started. The process parameters are approved by the signatories determined as part of the overall validation of the product production process within the system.

Finally, as shown in Figure 8, once the process parameter table has been approved it is used for the purposes of monitoring the production process. Should there ever be a requirement to change aspects of the process parameter table then these changes must be performed in a controlled manner. The inherent change control mechanisms of the system meet compliance regulations and ensure the changes are recorded. The table is revised as part of the change control process, the superseded revision is archived in a read-only format, the new revision is created as an unapproved table, allowing for edits, but preventing the process from being started until approved. - 30 -

It will of course be understood that the invention is not limited to the specific details described herein, which are given by way of example only, and that various modifications and alterations are possible within the scope of the invention as defined in the appended claims.

Claims

- 31 -CLAIMS :

1. Computer apparatus for validating a process control and operation system, the apparatus comprising means for preparing a process validation routine from inputted data, means for revising, approving and/or altering the routine, interface means for monitoring, collecting data from and directing the control system, means for storing the collected data in an information storage and revision area and means for retrieving inputted and collected data from the information storage and revision area.

2. Apparatus according to claim 1 , in which the process control and operation system is external to the apparatus.

3. Apparatus according to Claim 2, including means for preventing access to the process control and operation system except via the interface means following approval of the process validation routine by the approving means.

4. Apparatus according to Claim 3, including means for preventing the control system from initiating the process pending approval of the process validation routine.

5. Apparatus according to any preceding claim, including means for storing process parameter data, means for comparing data collected by the interface means with the process parameter data and means for generating a fault report and/or for causing the control system to alter or shut-down the process when the collected data is not in compliance with the process parameter data.

6. Apparatus according to any preceding claim, in which the means for preparing the process validation routine includes means for editing, revising, approving or - 32 -

post-approval changing any inputted or collected data, or any subset thereof.

7. Apparatus according to any preceding claim, including means for limiting access to stored data or any subset thereof to specified authorised users.

8. Apparatus according to Claim 7, in which the access limiting means includes means for according varying access-level privilege to different users, including read-only access, data edit or revision access, data approval access and post-approval process change access.

9. Apparatus according to any preceding claim, including means for archiving all inputted and collected data, including all data edits, revisions, approvals or post-approval process changes to a read-only memory.

10. Apparatus according to any of Claims 7 to 9, including means for periodically requiring an authorised user to alter his password for accessing stored data.

11. Apparatus according to any preceding claim, in which the means for preparing the process validation routine includes means for assigning each step of the routine a pre-requisite status within the overall routine and means for enabling the approval of any step only when all preceding pre-requisite steps in the routine have been approved.

12. Apparatus according to Claim 11, including means for displaying the routine and for showing the position of any step in the routine according to its position in the approval sequence. - 33 -

13. A method for validating a process control and operation system, the method comprising preparing a process validation routine from inputted data, revising, approving and/or altering the routine, monitoring, collecting data from and/or directing the control system, storing the collected data in an information storage and revision area and retrieving inputted and collected data from the information storage and revision area.

14. A method according to claim 13, in which the process control and operation system is external to the apparatus.

15. A method according to Claim 14, including restricting access to the process control and operation system following approval of the process validation routine.

16. A method according to Claim 15, including preventing the control system from initiating the process pending approval of the process validation routine.

17. A method according to any of Claims 13 to 16, including storing process parameter data, comparing collected data with the process parameter data and generating a fault report and/or causing the control system to alter or shut-down the process when the collected data is not in compliance with the process parameter data.

18. A method according to any of Claims 13 to 17, in which preparing the process validation routine includes editing, revising, approving or post-approval changing any inputted or collected data, or any subset thereof.

19. A method according to any of Claims 13 to 18, including limiting access to stored data or any subset - 34 -

thereof to specified authorised users.

20. A method according to Claim 19, in which limiting access to stored data includes according varying access-level privilege to different users, including read-only access, data edit or revision access, data approval access and post-approval process change access.

21. A method according to any of Claims 13 to 20, including archiving all inputted and collected data, including all data edits, revisions, approvals or post-approval process changes to a read-only memory.

22. A method according to any of Claims 19 to 21, including periodically requiring an authorised user to alter his password for accessing stored data.

23. A method according to any of Claims 13 to 22, in which preparing the process validation routine includes assigning each step of the routine a pre-requisite status within the overall routine and enabling the approval of any step only when all preceding pre-requisite steps in the routine have been approved.

24. A method according to Claim 23, including displaying the routine and showing the position of any step in the routine according to its position in the approval sequence.