Revision Control Log for Multi-User Pharmacovigilance Files
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Solution Overview
Problem
Existing systems for revision control of electronic pharmacovigilance safety master files (PSMFs) are limited in their ability to track and manage revisions in a multi-accessible and efficient manner, often requiring single-user access and increased processing power and memory.
Innovation Solution
A method for revision control that involves receiving requests to merge new sections of an electronic file with current sections, generating versioned sections, creating revision log entry data objects, and compiling these into an electronic revision log document, allowing for multi-accessible and efficient tracking of revisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If existing systems for revision control are used, then single-user access is maintained, but multi-user simultaneous access capability is limited
Solution Approach 1:
The revision control system is segmented into independent components: revision log entry data objects, versioned sections, and compilation modules. Each user's revisions are captured as separate data objects with unique identifiers, allowing simultaneous access without conflict. The system divides the revision control process into discrete steps (capture, versioning, compilation) that can be executed independently by multiple users concurrently.
Solution Approach 2:
The system creates copies of revision data in a standardized format (revision log entry data objects) that can be simultaneously accessed and processed by multiple users. Each user's revisions are copied into the shared revision log structure, allowing simultaneous viewing and processing without blocking other users' operations.
2Reliability
If existing revision control systems are used, then revision tracking is maintained, but processing power and memory requirements increase
Solution Approach 1:
The system changes the data structure parameters to compact forms: revision log entry data objects contain only essential fields (date, user identifier, revision description), versioned sections use efficient formatting, and the compilation process generates condensed electronic revision log documents. These parameter optimizations reduce memory consumption and processing requirements while maintaining complete revision tracking capability.
3Measurement precision
If manual revision tracking is used, then simple implementation is maintained, but accuracy and timeliness of revision capture deteriorates
Solution Approach 1:
The system implements self-service automation where the revision control mechanism automatically captures revisions without requiring manual intervention. The system automatically generates revision log entry data objects, assigns version numbers to sections, and compiles the electronic revision log document, eliminating the need for manual tracking while ensuring accurate and timely capture of all revisions.
Solution Approach 2:
The system incorporates feedback mechanisms that automatically detect and record revisions as they occur. The revision control system monitors changes to electronic files, captures revision information in real-time, and provides feedback through the compiled electronic revision log document, ensuring accurate tracking without manual oversight.
Data Source
AI summary
A method for revision control of an electronic file including receiving a request to merge a new section of the electronic file with a current section of the electronic file. The method further includes selecting the electronic file based on the request. The electronic file includes multiple sections; each including a revision log including at least one revision log entry data object. The method further includes generating a versioned section. The method further includes generating a revision log entry data object based on the request and the versioned section of the electronic file. The method further includes adding the revision log entry data object to the revision log of the versioned section. The method includes generating an electronic revision log document by compiling at least a portion of each revision log entry data object by date. The method further includes adding the electronic revision log document to the electronic file.