483 from BioQuality, Vol. 14(9): Use of Uncontrolled Excel Spreadsheet

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Ofni Systems

Uncontrolled Excel spreadsheet is used for: • issuance of deviation numbers • tracking deviations to closure • trending deviation data This has resulted in: • CAPAs not always being linked to associated deviations • Deviation priority levels not always being consistent Validation of QC lab software failed to demonstrate adequate security: • Analysts have the ability to overwrite original data • No individual user names and passwords limiting access to the system “


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