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USFDA audit compliance challenges-Data integrity is still a high frequency concern

The common data integrity problems that have been observed by FDA inspectors in past: Non contemporaneous Recording: Failure to record activities at the time when activity was performed. There is evidence that the records were signed by company personnel when the person was actually absent on that day. Document back-dating: Backdating stability test results to meet the required commitments. Copy of existing data as new information: Test results from previous batches were used to substitute testing for another batch or acceptable test results were created without performing the test. Re-running samples to obtain better results: Multiple analyzes of assay were done with the same sample without adequate justification and in some cases samples were tested unofficially or as a trial analysis until desired test results obtained. Data fabrication and data discarding: Original raw data and records were altered for e.g., by using of correction fluid or Manipulation of a poorl...
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