Data processing: database and file management or data structures – Database design – Data structure types
Reexamination Certificate
1997-09-12
2001-08-07
Alam, Hosain T. (Department: 2172)
Data processing: database and file management or data structures
Database design
Data structure types
C707S793000, C707S793000, C707S793000
Reexamination Certificate
active
06272506
ABSTRACT:
FIELD OF INVENTION
This application contains a microfiche appendix consisting of 1 sheet and 70 frames.
This invention relates to a computerized form processing system and method which provides an automatic and positive audit trail of changes made to data entries in electronic forms.
BACKGROUND OF INVENTION
The benefits of computerized forms as compared to paper forms are numerous. Data entry is easier and faster, paper costs are reduced, storage space is optimized, retrieval is faster, and data integrity is ensured. Moreover, because of the use of database and spreadsheet technology, reports concerning data entered on the forms can be generated much faster and even automatically. Configuration control is also made easier. Finally, when a computer network is used, data entry can be monitored in real time and multiple users can access a given form and its data simultaneously.
In contrast, when paper forms are used, data entry is slow, the paper version of the form plus the required copies take up an inordinate amount of storage space, and retrieval of paper forms requires a manual filing system. Report generation involves manually going through a number of completed forms to extract the required data. Finally, a manual configuration control system must be implemented.
Computerized forms overcome these and many other disadvantages of paper forms. Still, computerized forms do suffer from some shortcomings. For example, computers typically handle data entry changes by completely eliminating the old values and replacing them with the most current values. For example, if the value of 25 is typed into a field of a spreadsheet or database and then this value is replaced by the value 26, there will be no record of the old value 25 using current electronic form generation products.
This deficiency in computerized databases and spreadsheets has severely affected the implementation of computerized forms in some industries. For example, the Food and Drug Administration (FDA) has issued regulations which require pharmaceutical companies and other companies regulated by the FDA to cross out an incorrect data entry so that it can still be read and also require data entry personnel to initial or sign in association with the change. Similar rules apply in many diverse industries, including data recording requirements for military testing and inspection procedures and medical patient records. The reason for these cross out and initial or sign procedures is to provide a clear audit trail for evaluation purposes should a drug, military device, or medical procedure fail to perform as specified or worse, harm individuals or groups of individuals.
As delineated above, currently known computerized paperless form generation systems cannot implement this cross out and initial requirement because, by their very nature, computers allow changes to be made to data without keeping a record of the data changes. Indeed, one of the advantages of computerized data entry is the ease of making changes. Another problem with computerized forms is the unusual ease with which unauthorized modifications can be made. Since all of the data, the form itself, and even any electronic or digital biometric signatures associated with the form are really just stored computer records, unauthorized access to these records can be made despite security algorithms and changes or modifications can be made severely affecting the integrity of the data. For example, pharmaceutical company personnel facing an investigation and/or a lawsuit, may retrieve old records and improperly change certain data entries to escape culpability and/or liability.
Accordingly, the change from paper based forms to computerized forms has not been implemented in some industries as quickly as desired and one regulatory agency, namely the FDA, closely scrutinizes any attempt to computerize the standard operating procedures (“SOP”) batch form used by pharmaceutical companies to keep a record of pharmaceutical manufacturing processes.
SUMMARY OF INVENTION
It is therefore an object of this invention to provide an improved computerized form processing system and method.
It is a further object of this invention to provide such a system and such a method which automatically keeps track of all data entry changes.
It is a further object of this invention to provide such a system and such a method which complies with FDA requirements concerning data entry changes.
It is a further object of this invention to provide such a system and such a method which automatically flags a changed entry and which allows the user to initialize the change in accordance with the FDA's requirements.
It is a further object of this invention to provide such a system and such a method which allows authorized users to effect a change by entering new data and then initialing or signing the new entry via a digital biometric signature or initial capture or by electronic signatures that require two separate identifiers in accordance with FDA requirements. In such a case it is an object of this inventions to automatically flag the changed entry so that it is visibly different from an unchanged entry, both on the computer screen and on the printed (output) form, as well as in exception reports.
It is a further object of this invention to provide such a system and such a method which provides a clear audit trail of all data entry events associated with a paperless form.
It is a further object of this invention to provide such a system and such a method which automatically verifies the integrity of stored completed forms.
This invention results from the realization that a computerized form processing system which complies with current good manufacturing procedures thereby providing an audit trail for authorized changes to data entered on computerized forms can be implemented by a unique routine or set of routines which automatically monitor whether a value is changed after it is first entered into the form and, if so, requires the user to authorize the change by sign off before the changed value will be accepted, and which then flags the changed value and stores the previous value, the changed value, the user's initials, and the date and time each value was entered. Both in the application screens, and during output (e.g. printout), the fact that a change was made to a value is automatically made apparent to the reviewer.
This invention results from the further realization that if field check sums of all values entered on a computerized form are performed as the form is being completed and then a final summation checksum if performed after the form is completed, then later if any unauthorized changes are made, the check sum values will be different thereby providing a verification to ensure that stored data is not corrupted. Any subsequent access to the form will result in recalculation of the summation checksum, and comparison of that value with the previously stored value. If there is a discrepancy, access will be denied, and an error report will be generated.
This invention features a computerized form processing system comprising: a database for storing a form including one or more fields; a viewer for viewing a stored form; a data entry device for entering information into the fields of a form; means for monitoring whether the information in a said field has changed; and means for automatically flagging any changes to the information entered into a field.
All the information entered into a field including all revisions, are automatically stored in a database. The viewer is preferably a touch screen and then the data entry device includes a pen device.
Further included may be a field modification verification routine for authorizing a change to information entered into a field. This routine includes means for displaying a signature block on the screen and means for verifying that an authorized entry is made to the signature block. The field modification verification routine further includes means for resetting the field to reflect the previous information entered into the field if the
Alam Hosain T.
Doxis, LLC
Iandiorio & Teska
Kindred Alford W.
Teska Kirk
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