Notice of Concern from World Health Organization: Company Failed to Ensure Integrity of Data

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Ofni Systems

” Quotes from the Notice:

The company failed to ensure the integrity of data:…
Batch numbers were not electronically recorded…
Hundreds of trial injections… in sequence… were seen in folder c:…
Data was found to be deleted for several runs…
The backups could not be restored during the inspection.
Instrument audit trails were not available…
An analyst was seen in process of taking tablet weight data from a calculation spreadsheet in Excel and writing the values down in his analytical test sheet as if these were the raw weighing values.”

View the original Notice of Concern.


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