ABSTRACT
The discrepancy or query that is generated automatically or created manually is stored in the data management or EDC system permanently as a record of database cleaning and site responses. System software will track the status of each discrepancy and query until it is resolved. (This is in addition to the audit trail of the data that all 21 CFR [Code of Federal Regulations] Part 11-compliant systems support.) The workœow of identifying a discrepancy, generating a query, and obtaining a —nal resolution varies somewhat across companies because of restrictions placed by the software system being used and also because different companies have different philosophies on query resolution and different resources to apply to the process.
