Tips for Data Integrity During Inspections

When assessing data integrity, several symptoms might signal underlying issues. Some of the most common indicators include:Click to read the full article.

During a recent internal audit preceding an FDA inspection, a quality control analyst noticed discrepancies in laboratory data records related to stability testing for a critical drug product. Multiple instances…

The first step in addressing data integrity concerns during inspections is recognizing the symptoms or signals that indicate possible non-compliance. Observations can range from incomplete audit trails to improperly secured…