Electronic Record Repository with XML Segmentation and Signature Rules
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Solution Overview
Problem
Existing electronic record systems face challenges in efficiently searching and securely accessing XML-based electronic records due to their flexible structure, and in managing electronic signatures required for compliance with regulations like GMPs.
Innovation Solution
A method and system for securely storing and accessing electronic records, which includes automatically creating electronic records, determining the need for electronic signatures, associating signatures with records, and securely searching unstructured data in a database, using a common repository with an audit trail and security protocols to manage access and compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If electronic records are stored in a common repository with flexible XML structure, then adaptability and information storage capability are improved, but searching efficiency and access security deteriorate
Solution Approach 1:
The patent segments the unstructured XML data into structured components by creating a relational database schema that maps XML elements to database tables. This segmentation allows efficient querying of specific data elements while maintaining the flexibility of XML storage, resolving the contradiction between adaptable storage and searching efficiency.
Solution Approach 2:
The patent introduces an intermediary layer consisting of database views and query interfaces that mediate between the flexible XML storage and the searching requirements. This intermediary structure enables efficient access to specific data elements without compromising the underlying flexible XML format, thus resolving the efficiency issue.
2Adaptability or versatility
If electronic records are stored in a common repository with flexible XML structure, then adaptability and information storage capability are improved, but access security and controlled access deteriorate
Solution Approach 1:
The patent segments access control by implementing role-based security at the database level, where different user roles can access different portions of the XML data. This segmentation allows the system to maintain flexible XML storage while enforcing granular security controls on specific data elements, resolving the security concern.
3Reliability
If electronic signatures are required for all transactions affecting product quality, then compliance with GMPs is improved, but system complexity and operational overhead increase
Solution Approach 1:
The patent implements automatic determination of signature requirements through database triggers and rules引擎 that evaluate transaction characteristics against compliance criteria. This self-service approach automatically identifies when signatures are needed based on the transaction type and data changes, reducing manual assessment complexity while maintaining GMP compliance.
4Ease of operation
If manual tracking of hard copy records is used, then ease of physical security control is improved, but time consumption for searches and access control increases
Solution Approach 1:
The patent replaces the mechanical physical record-keeping system with an electronic database system that uses digital security controls and automated searching. This substitution eliminates the time-consuming manual search process while implementing electronic access controls that provide efficient security management, resolving the time loss issue.
Data Source
AI summary
A method of and system for collecting an electronic signature for an electronic record stored in a database. In one embodiment the method comprises automatically creating an electronic record from data stored in a plurality of different database tables in response to the occurrence of a predetermined event; storing an instance of the electronic record in a common repository of electronic records that provides an audit trail that cannot be altered or disabled by users of the system; executing a rule associated with the electronic record to determine whether an electronic signature is required to connote review and/or approval of the electronic record; and if execution of the rule results in a determination that an electronic signature is required, marking the instance of the electronic record as unsigned and initiating a request to collect the required electronic signature. In some embodiments the electronic record is stored as unstructured data in a character large object (CLOB) format and the unstructured data comprises a well-formed XML document stored within a column of a table stored in the database.