Process-linked data management system

• US 20020193966A1
• Filed: 07/26/2002
• Published: 12/19/2002
• Est. Priority Date: 10/10/2000
• Status: Active Grant

• Current Assignee: Dassault Systemes Americas Corp. (Dassault Systemes SA)
• Original Assignee: Velquest Corporation (Dassault Systemes SA)
• Inventors: Hutchins, Burleigh M., Buote, William, Rapp, Kenneth N.
• Granted Patent: US 7,092,839 B2
• Time in Patent Office: Days
• US Class Current: 702/183
• CPC Class Codes: G06F 16/24 Querying
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A system for managing and reporting laboratory data wherein the data is obtained at remote data-taking stations, transferred instantaneously by wireless communication to a main data-storing/manipulating station for recording therein without being recorded at the remote data-taking stations, and reported only from the data-storing/manipulating.

Claims

1. A method of electronically managing measured, calculated and observed data of the type requested by pre-existing procedures and obtained through analytical instrumentation or by observation, said method comprising the steps of:

providing a data manipulating device which contains an information management program,

loading a single document containing said pre-existing procedures into said data manipulating device, wherein said data manipulating device creates a set of procedural instructions,

providing said procedural instructions to said program, for use thereby in the generation of a batch record database and a report format,

providing said procedural instructions to one or both of said analytical instrumentation and an observer, for use thereby in the taking of one or both of said measured and observed data and information from which said calculated data is generated,

retrieving any taken of said measured and said observed data into said batch record database,

retrieving any taken of said information into said program for generation thereof into said calculated data and then retrieving said calculated data into said batch record database,

combining said one or more of said measured, calculated and observed data from said batch record database with said report format by sale program, to produce a final report therefrom, and wherein

said data and information are only recorded within said batch record and said final report.

2. The method of claim 1 further comprising the step of confirming the calibration status of said analytical instrumentation by said program, and wherein said taking of said data without said confirmation of proper calibration is denied.

3. The method of claim 1 further comprising the step of confirming the calibration status of said analytical instrumentation by said program, and wherein said taking of said data without said confirmation of proper calibration causes said taken data to be identified as improper data in both said batch record database and said final report.

4. The method of claim 1 wherein said retrieving said one or more of said measured and said observed data into said batch record database and said information into said program is by wireless communication.

5. The method of claim 4 further comprising the step of confirming the calibration status of said analytical instrumentation by said program and wherein said taking of said data without said confirmation of proper calibration is denied.

6. The method of claim 4 further comprising the step of confirming the calibration status of said analytical instrumentation by said program and wherein said taking of said data without said confirmation of proper calibration causes said taken data to be identified as improper data in both said batch record database and said final report.

7. In a system for managing and reporting laboratory data of the type produced at one or more remote data-taking stations in accordance with a set of pre-existing procedures and formatted into a report, and wherein said procedures require the preservation of any data recorded at said remote data-taking stations, the improvement wherein said data, once produced, is transmitted instantaneously from each of said one or more remote data-taking stations to a main data-storing and data-manipulating station without being recorded at said one or more remote data-taking stations, to thereby avoid said preservation requirement at said remote data-taking stations.

8. The improvement of claim 7 wherein said main data-storing and data-manipulating device is a computer having a program for combining said pre-existing procedures with said laboratory data and into a final report, said final report describing both said procedures and said laboratory data.

9. The improvement of claim 8 wherein said program further produces test instructions from said pre-existing procedures and said remote data-taking stations receive said instructions and produce said laboratory data in accordance therewith.

10. The improvement of claim 9 wherein said instructions further include the requirement for the taking of meta-data at the remote data-taking stations and said meta-data is transmitted to said computer and said final report further describes said meta-data.

11. The improvement of claim 10 wherein said meta-data further includes remote data-taking station calibration data and said instructions further include the requirement for the confirmation of proper calibration of said remote data-taking stations and wherein said taking of said data without said confirmation of proper calibration is denied by said program.

12. The improvement of claim 10 wherein said meta-data further includes remote data-taking station calibration data and said instructions further include the requirement for the confirmation of proper calibration of said remote data-taking stations and wherein said taking of said data without said confirmation of proper calibration causes said taken data to be identified as improper data by said program.

13. The improvement of claim 7 wherein said data is transferred instantaneously from said each of said one or more remote data-taking stations to said main data-storing and data-manipulating station by wireless communication.

14. The improvement of claim 13 wherein said main data-storing and data-manipulating device is a computer having a program for combining said pre-existing procedures with said laboratory data and into a final report, said final report describing both said procedures and said laboratory data.

15. The improvement of claim 14 wherein said program further produces test instructions from said pre-existing procedures and said remote data-taking stations receive said instructions and produce said laboratory data in accordance therewith.

16. The improvement of claim 15 wherein said instructions further include the requirement for the taking of meta-data at the remote data-taking stations and said meta-data is transmitted to said computer and said final report further describes said meta-data.

17. The improvement of claim 16 wherein said meta-data further includes remote data-taking station calibration data and said instructions further include the requirement for the confirmation of proper calibration of said remote data-taking stations and wherein said taking of said data without said confirmation of proper calibration is denied by said program.

18. The improvement of claim 16 wherein said meta-data further includes remote data-taking station calibration data and said instructions further include the requirement for the confirmation of proper calibration of said remote data-taking stations and wherein said taking of said data without said confirmation of proper calibration causes said taken data to be identified as improper data by said program.

19. A method of minimizing record-keeping requirements during the evaluation of medical, pharmaceutical and biological products wherein all auditable data taken at remote analytical instrumentation is transferred instantaneously and electronically to a central data-recording apparatus, and wherein said auditable data is recorded only in said central data-recording apparatus.

20. A method of ensuring reliability in auditable data from analytical instruments during evaluation of medical, pharmaceutical and biological products wherein each instrument'"'"'s calibration status is electronically confirmed before said data taken therefrom is accepted.

21. The method of claim 20 wherein all of said auditable data taken at said analytical instruments is transferred instantaneously and electronically to a central data-recording apparatus, and wherein said auditable data is recorded only in said central data-recording apparatus.