Deviation Case Studies – Page 17

Repeat DI lapses tolerated during data review – remediation failure analysis

The investigation began when several discrepancies in data entries were noted during routine audits of batch records and laboratory data sets. The symptoms included:Click to read the full article.

QA oversight failure in DI during data review – 483 observation breakdown

The initial symptoms of the issue were reported during routine data review sessions when an employee noticed discrepancies in recorded data entries versus the laboratory instruments’ outputs. Key indicators of…

QA oversight failure in DI during FDA inspection – 483 observation breakdown

During routine monitoring, discrepancies were noted in batch release data where the documented results did not match the raw data from electronic systems. Not only were discrepancies present, but they…

Repeat DI lapses tolerated during system validation – 483 observation breakdown

In early 2023, employees at a pharmaceutical manufacturing site began noticing discrepancies in the data collected during system validation processes. Frequent instances of data entry errors were reported, particularly in…

Audit trail deletion identified during data review – warning letter risk explained

Case Study: Understanding and Addressing Audit Trail Deletion During Data Review In a recent audit of a pharmaceutical manufacturing facility, inspectors identified a concerning issue: the deletion of critical audit…

Uncontrolled spreadsheet calculations during system validation – remediation failure analysis

When cross-functional teams involved in validation activities discovered anomalies, including unexpected or incorrect system performance, symptoms on the manufacturing floor quickly emerged. Employees noted discrepancies between validation reports and the…

QA oversight failure in DI during data review – warning letter risk explained

The case began when a quality control analyst flagged discrepancies in batch production records which should have been identical across data sets. While reviewing results from a recent batch analysis,…

Manual result transcription without verification during FDA inspection – remediation failure analysis

During a routine FDA inspection, the inspection team identified discrepancies between manually transcribed laboratory results and the automated results displayed in the laboratory information management system (LIMS). Not only were…

Uncontrolled spreadsheet calculations during internal audit – remediation failure analysis

The uncontrolled spreadsheet calculations were first identified during a routine internal audit conducted by the QA department. Initial indicators included discrepancies in reported batch yields compared to the actual yields…

Repeat DI lapses tolerated during system validation – warning letter risk explained

In this case, the symptoms of underlying data integrity issues emerged gradually, with several indicators surfacing around the same time:Click to read the full article.

Manual result transcription without verification during data review – warning letter risk explained

In our case study, the initial signs of a potential data integrity issue surfaced during routine data reviews for batch release in a quality control laboratory. Quality assurance personnel noticed…

Manual result transcription without verification during data review – 483 observation breakdown

During a routine internal audit, discrepancies were noted in laboratory results during data review, specifically involving manual transcription of results. Operators were manually entering results from bench worksheets into electronic…