Process control method with integrated database for electronically documenting the configuration, modification and operation of a controlled process

• US 20050038565A1
• Filed: 04/26/2004
• Published: 02/17/2005
• Est. Priority Date: 04/25/2003
• Status: Active Grant

• Current Assignee: Symblon Systmes, Inc.
• Original Assignee: Symblon Systmes, Inc.
• Inventors: Power, Michael A., Kramer, Richard
• Granted Patent: US 7,941,396 B2
• Time in Patent Office: Days
• US Class Current: 700/266
• CPC Class Codes: G05B 19/042 using digital processors G05B19/05 takes precedence
• CPC Class Codes: G05B 19/4183 characterised by data acquisition, e.g. workpiece identification
• CPC Class Codes: G05B 2219/25061 Configuration stored in central database
• CPC Class Codes: G05B 2219/31323 Database for CIM
• CPC Class Codes: G05B 2219/31396 Business management, production, document, asset, regulatory management, high level
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 50/26 Government or public services business processes related to the transportation industry G06Q50/40
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y02P 90/02 Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]

Abstract

A process control method that automatically and comprehensively manages the creation, storage and use of electronic records during the operation of a controlled process and for governing and documenting the users that operate the computer systems that are involved in the creation, storage and use of the electronic records. The method controls a process, such as a chemical process, by receiving measurement information relating to the process, applying rules to the received measurement information to determine a desired response, and sending control information to at least one device associated with the process, so as to modify the process. The method maintains the rules, measurements and control activity in transaction logs or audit trails related thereto in a secure database. By providing convenient, centralized control of the process within a secure database, the method enhances compliance with the FDA regulations that permit electronic records to be regarded as the equivalent to paper records under 21 CFR Part 11.

Claims

1. A method of managing and electronically documenting the configuration, modification, and operation of a process that is monitored by a measuring device and influenced by a control device, the method comprising the steps of:

receiving data from the measuring device;

providing a database management system with a data structure for storing data records relating to user data, configuration data, and instrument data in corresponding user data records, configuration data records, and instrument data records; and

providing a supervisor application for controlling the database management system, the supervisor application implementing the substeps of;

limiting access to the database management system to authorized users based on the user data in the user data records;

allowing an authorized user to modify the configuration data in the configuration data records;

successively storing changes to the configuration data in the configuration data records, along with an identifier as to the user data record corresponding to the user who modified the configuration data to produce an electronic audit trail for configuration data;

receiving data from the measuring device in accordance with the configuration data in the configuration data records;

successively storing data received from the measuring device in instrument data records, along with an identifier as to the configuration data record corresponding to the configuration data that was in effect when the data was received, to produce an electronic audit trail for instrument data; and

outputting control signals to the control device, in accordance with the configuration data in the configuration data records, based on the data received from the measuring device.

2. The method of claim 1 wherein the process is a chemical process.

3. The method of claim 1 wherein the process is a process governed by 21 CFR, Part 11, promulgated by the United States Food and Drug Administration.

4. The method of claim 1 wherein the step of successively storing changes to the configuration data in the configuration data records is accomplished for each manual save operation.

5. The method of claim 1 wherein the measuring device is selected from the group comprising:

a spectrometer;

a gas chromatograph;

a temperature sensor;

a pressure sensor;

a weight sensor;

an optical sensor;

a timer;

a flow sensor;

a current sensor;

a voltage sensor;

a capacitance sensor;

a inductance sensor;

an electric field sensor;

a magnetic field sensor;

a specific gravity sensor; and

a concentration sensor.

6. The method of claim 1 wherein the control device is selected from the group comprising:

a valve;

a heater;

a cooler;

a mixer;

a current source;

a voltage source;

an electric field source;

a magnetic field source; and

a laser.

7. A method for controlling a process, the method comprising:

receiving measurement information via a network;

applying rules to the received measurement information to determine a desired response; and

sending control information via the network, the control information facilitating control of at least one control device according to the desired response,

the method comprising the further step of storing the measurement information, the rules, and administrative information in a common database wherein access to the database is limited to authorized users.

8. The method as recited in claim 7, wherein the measurement information is received via an Ethernet and wherein the control information is sent via the Ethernet.

9. The method as recited in claim 7, wherein the measurement information is received via the Internet and wherein the control information is sent via the Internet.

10. The method as recited in claim 7, wherein the measurement information is received by a process control system having an IP address from at least one measurement device having an IP address and the control information is sent by the process control system to at least one control device having an IP address.

11. The method as recited in claim 7, wherein the measurement information is representative of at least one measurement of an analytical instrument.

12. The method as recited in claim 7, wherein the measurement information comprises data representative of a measurement made using at least one device selected from the group comprising:

a spectrometer;

a gas chromatograph;

a temperature sensor;

a pressure sensor;

a weight sensor;

an optical sensor;

a timer;

a flow sensor;

a current sensor;

a voltage sensor;

a capacitance sensor;

a inductance sensor;

an electric field sensor;

a magnetic field sensor;

a specific gravity sensor; and

a concentration sensor.

13. The method as recited in claim 7, wherein the measurement information comprises data representative of a measurement made by a spectrometer.

14. The method as recited in claim 7, further comprising:

maintaining an integrity of the database when a new database is desired, such that the old database is still available to provide a history of usage.

15. The method as recited in claim 7, further comprising:

associating a time stamp and a user name with modifications to the database.

16. The method as recited in claim 7, further comprising:

using a transition log to create an audit trail which provides information relating to modifications of the database.

17. The method as recited in claim 7, further comprising:

using a transition log to create an audit trail which provides information relating to modifications of the database and wherein the transition log is accessible only to authorized users.

18. The method as recited in claim 7, further comprising analyzing at least a portion of the information representative of at least one measurement so as to facilitate control of at least one control device.

19. The method as recited in claim 7, further comprising defining the rules.

20. The method as recited in claim 7, further comprising defining the rules by dragging and dropping at least one of graphic symbols representing measurement devices and graphic symbols representing control devices.

21. The method as recited in claim 7, further comprising defining the rules by dragging and dropping at least one of graphic symbols representing measurement devices and graphic symbols representing control device(s) and applying desired parameters thereto.

22. The method as recited in claim 7, wherein the rules are defined by scripts.

23. The method as recited in claim 7, wherein the rules are defined using a tool command language.

24. A method for controlling a process, the method comprising:

storing rules in a database;

receiving measurement information;

storing the received measurement information in the same database;

applying the rules to the measurement information to determine a desired response; and

sending control information, the control information facilitating control of at least one control device according to the determined desired response.

25. The method as recited in claim 24, further comprising storing administrative information in the same database.

26. The method as recited in claim 24, further comprising storing information representative of the control information in the database.

27. The method as recited in claim 24, wherein:

receiving measurement information comprises receiving measurement information via a network; and

sending control information comprises sending control information via the network.

28. The method as recited in claim 24, wherein:

receiving measurement information comprises receiving measurement information via an Ethernet; and

sending control information comprises sending control information via the Ethernet.

29. The method as recited in claim 24, wherein:

receiving measurement information comprises receiving measurement information via the Internet; and

sending control information comprises sending control information via the Internet.

30. The method as recited in claim 24, wherein the measurement information is received by a process control system having an IP address from at least one measurement device having an IP address and the control information is sent by the process control system to at least on control device having an IP address.

31. A process control system comprising:

a general purpose computer configured to communicate via a network;

a database configured to contain rules for determining desired responses to measurement information; and

wherein the computer is configured to receive measurement information via the network, apply the rules to the received measurement information to determine a desired response, and send control information via the network.

32. The process control system as recited in claim 31, wherein the computer has an IP address and is configured to receive measurement information from at least one measurement device having an IP address and is configured to send control information to at least on control device having an IP address.

33. The process control system as recited claim 31, wherein the database is configured to contain received measurement information.

34. The process control system as recited claim 31, wherein the database is configured to contain a log of measurements and corresponding control information.

35. The process control system as recited claim 31, wherein the database is configured to contain measurements, corresponding control information, and administrative information.