System and method for electronic record keeping

• US 20070124278A1
• Filed: 10/30/2006
• Published: 05/31/2007
• Est. Priority Date: 10/31/2005
• Status: Abandoned Application

• Current Assignee: Biogen Idec MA Inc. (Biogen, Inc.)
• Original Assignee: Biogen Idec MA Inc. (Biogen, Inc.)
• Inventors: Lewis, William, Watson, Brian, Kinch, Deborah
• Application Number:
  US11/589,064
• Publication Number:
  US 20070124278A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G16B 50/00 ICT programming tools or database systems specially adapted for bioinformatics
• CPC Class Codes: G16B 50/30 Data warehousing; Computing architectures

Abstract

A system and method of keeping records includes recording information and metadata associated with the information. The metadata is protected from changes. The information can be displayed to a second user for acknowledgement. Acknowledgement by the second user can also be recorded. The metadata can provide an audit trail for reviewing additions, deletions and changes to the records.

Claims

1. A method of keeping records, comprising:

recording on a computer-readable medium information entered by a first user to provide a first computer-readable record, and metadata associated with the first computer-readable record, wherein the metadata is protected from changes;

displaying the first computer-readable record to a second user for acknowledgement; and

recording, on a computer-readable medium, an acknowledgement by the second user of the information entered by the first user.

2. The method of claim 1, wherein recording the acknowledgement includes recording an approval or a disapproval of the information entered by the first user.

3. The method of claim 1, wherein the acknowledgement includes a comment by the second user.

4. The method of claim 2, wherein recording a disapproval includes requiring the second user to record a comment.

5. The method of claim 1, wherein the metadata associated with the first computer-readable record includes an identity of the first user, a date, a time, or a combination thereof.

6. The method of claim 1, wherein the information entered by the first user includes information describing a laboratory manipulation carried out by the first user.

7. The method of claim 6, wherein the laboratory manipulation is performed according to a standard operating procedure.

8. The method of claim 7, wherein the standard operating procedure specifies mandatory information describing the laboratory manipulation that must be recorded in order to comply with the standard operating procedure.

9. The method of claim 8, wherein the first user is required to enter the mandatory information.

10. The method of claim 6, wherein the information describing a laboratory manipulation includes a user identity, a sample identity, a sample description, an identity of a standard operating procedure, a version of a standard operating procedure, an equipment identity, a reagent identity, a reagent manufacturer, a reagent expiration date, a reagent amount, a reagent quantity, a start time of a manipulation, a stop time of a manipulation, a duration of a manipulation, an amplitude of a manipulation, a result of a measurement, an identity of a manipulated sample, a location of a manipulated sample, a user comment, or a combination thereof.

11. The method of claim 6, wherein the laboratory manipulation includes a manipulation related to a nucleic acid preparation, a nucleic acid purification, a nucleic acid labeling, a protein preparation, a protein purification, a protein labeling, a metabolite preparation, a metabolite purification, or a metabolite labeling.

12. The method of claim 6, wherein the laboratory manipulation includes a gene expression profiling experiment, an ELISA-based assay, a cell-based assay, a flow cytometry assay, a multiplex bead-based assay, a proteomics assay, a PCR-based assay, a spectrophotometric analysis, a gel electrophoresis experiment, a capillary electrophoresis experiment, or a combination thereof.

13. The method of claim 6, wherein the laboratory manipulation includes a manipulation related to tissue homogenization, total RNA preparation, cRNA preparation, or hybridization of cRNA to a DNA array.

14. The method of claim 1, further comprising recording on a computer-readable medium a comment from the first user when the second user disapproves of the first electronic record.

15. The method of claim 1, further comprising submitting the first computer-readable record to a regulatory agency.

16. The method of claim 1, further comprising recording on a computer-readable medium information entered by a first user to provide a second computer-readable record and metadata associated with the second computer-readable record to provide a collection of computer-readable records, wherein the metadata is protected from changes.

17. The method of claim 16, wherein the collection of computer-readable records is displayed to a second user for acknowledgement.

18. The method of claim 16, wherein the collection of computer-readable records describes a laboratory workflow.

19. The method of claim 16, further comprising modifying the collection by recording on a computer-readable medium a third computer-readable record and metadata associated with the third computer-readable record, wherein the third computer-readable record corresponds to and modifies an existing computer-readable record in the collection, wherein the existing computer-readable record and its associated metadata are retained in the collection.

20. The method of claim 16, further comprising recording on a computer-readable medium information entered by a first user to provide a plurality of computer-readable records and metadata associated with the each of the plurality of computer-readable records to provide a collection of computer-readable records, wherein the metadata is protected from changes.

21. The method of claim 20, further comprising generating an audit trail for the collection of computer-readable records from the metadata.

22. A computer program for record-keeping, the computer program comprising instructions for causing a computer system to:

record on a computer-readable medium information entered by a first user to provide a first computer-readable record, and metadata associated with the first computer-readable record, wherein the metadata is protected from changes;

display the first computer-readable record to a second user for acknowledgement; and

record, on a computer-readable medium, an acknowledgement by the second user of the information entered by the first user.

23. The computer program of claim 22, wherein the acknowledgement includes recording an approval or disapproval of the information entered by the first user.

24. The computer program of claim 22, wherein the acknowledgement includes a comment by the second user.

25. The computer program of claim 23, wherein recording a disapproval includes requiring the second user to record a comment.

26. The computer program of claim 22, wherein the metadata associated with the first computer-readable record includes an identity of the first user, a date, a time, or a combination thereof.

27. The computer program of claim 22, wherein the information entered by the first user includes information describing a laboratory manipulation carried out by the first user.

28. The computer program of claim 27, wherein the laboratory manipulation is performed according to a standard operating procedure.

29. The computer program of claim 28, wherein the standard operating procedure specifies mandatory information describing the laboratory manipulation that must be recorded in order to comply with the standard operating procedure.

30. The computer program of claim 29, wherein the first user is required to enter the mandatory information.

31. The computer program of claim 27, wherein the information describing a laboratory manipulation includes a user identity, a sample identity, a sample description, an identity of a standard operating procedure, a version of a standard operating procedure, an equipment identity, a reagent identity, a reagent manufacturer, a reagent expiration date, a reagent amount, a reagent quantity, a start time of a manipulation, a stop time of a manipulation, a duration of a manipulation, an amplitude of a manipulation, a result of a measurement, an identity of a manipulated sample, a location of a manipulated sample, a user comment, or a combination thereof.

32. The computer program of claim 27, wherein the laboratory manipulation includes a manipulation related to a nucleic acid preparation, a nucleic acid purification, a nucleic acid labeling, a protein preparation, a protein purification, a protein labeling, a metabolite preparation, a metabolite purification, or a metabolite labeling.

33. The computer program of claim 27, wherein the laboratory manipulation includes a gene expression profiling experiment, an ELISA-based assay, a cell-based assay, a flow cytometry assay, a multiplex bead-based assay, a proteomics assay, a PCR-based assay, a spectrophotometric analysis, a gel electrophoresis experiment, a capillary electrophoresis experiment, or a combination thereof.

34. The computer program of claim 27, wherein the laboratory manipulation includes a manipulation related to tissue homogenization, total RNA preparation, cRNA preparation, or hybridization of cRNA to a DNA array.

35. The computer program of claim 22, wherein the computer program includes instructions for causing a computer system to record on a computer-readable medium a comment from the first user when the second user disapproves of the first electronic record.

36. The computer program of claim 22, wherein the computer program includes instructions for causing a computer system to format the first computer-readable record for review by a regulatory agency.

37. The computer program of claim 22, wherein the computer program includes instructions for causing a computer system to recording on a computer-readable medium information entered by a first user to provide a second computer-readable record and metadata associated with the second computer-readable record to provide a collection of computer-readable records, wherein the metadata is protected from changes.

38. The computer program of claim 37, wherein the collection of computer-readable records is displayed to a second user for acknowledgement.

39. The computer program of claim 37, wherein the collection of computer-readable records describes a laboratory workflow.

40. The computer program of claim 37, wherein the computer program includes instructions for causing a computer system to modify the collection by recording on a computer-readable medium a third computer-readable record and metadata associated with the third computer-readable record, wherein the third computer-readable record corresponds to and modifies an existing computer-readable record in the collection, wherein the existing computer-readable record and its associated metadata are retained in the collection.

41. The computer program of claim 37, wherein the computer program includes instructions for causing a computer system to record on a computer-readable medium information entered by a first user to provide a plurality of computer-readable records and metadata associated with the each of the plurality of computer-readable records, to provide a collection of computer-readable records, wherein the metadata is protected from changes.

42. The computer program of claim 41, wherein the computer program includes instructions for causing a computer system to generate an audit trail for the collection of computer-readable records from the metadata.

43. A system for record-keeping, comprising:

a computer system configured to;

record on a computer-readable medium a plurality of information entered by a first user to provide a plurality computer-readable records, and metadata associated with the plurality of computer-readable records, wherein the information describes a laboratory manipulation carried out by the first user and the metadata is protected from changes;

display at least one of the plurality of computer-readable records to a second user for acknowledgement; and

record, on a computer-readable medium, an acknowledgement by the second user of information entered by the first user; and

a laboratory instrument in communication with the computer system, wherein the laboratory instrument is configured to communicate a result of a measurement to the computer system.

44. The system of claim 43, wherein the computer system is further configured record the result on the computer-readable medium to provide a second computer-readable record, and metadata associated with the second computer-readable record, wherein the metadata is protected from changes.

45. The system of claim 43, wherein the laboratory instrument includes a balance, a spectrophotometer, a spectrofluorometer, a centrifuge, a barcode reader, or a pipettor.

46. The system of claim 43, wherein the laboratory instrument includes a nucleic acid array reader.

47. The system of claim 43, wherein the laboratory manipulation is performed according to a standard operating procedure.

48. The system of claim 47, wherein the standard operating procedure specifies mandatory information describing the laboratory manipulation that must be recorded in order to comply with the standard operating procedure.

49. The system of claim 48, wherein the first user is required to enter the mandatory information.

50. The system of claim 43, wherein the computer system is configured to analyze the result.

51. The system of claim 43, wherein the computer system is configured to generate an audit trail for the plurality of computer-readable records from the metadata.

52. The system of claim 43, wherein the computer system is configured to format at least one of the plurality of computer-readable records for review by a regulatory agency.

53. The system of claim 43, wherein the computer system is configured to generate a report summarizing the plurality of computer-readable records.

54. The system of claim 53, wherein the computer system is further configured to store the report in an archive.