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Software System |
Key Function |
Subsets |
Database |
Store report information |
Quality management system (QMS), complaint tracking, investigation tracking, auditing |
Report engine |
Output data to paper and XML files |
Crystal reports, Excel, Access, eMDR output tool |
Electronic data interchange (EDI) |
Transmit data to FDA |
Ability to retrieve and process return messages from FDA and apply to database records |
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Table I. Main classes of software belonging to an eMDR system, listing key functions and subsets of each class.
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