Deviation Case Studies – Page 18

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…

QA oversight failure in DI during data review – remediation failure analysis

During routine batch record audits, it was noted that discrepancies were emerging in the data integrity of critical batch records. The QA team reported unusual patterns in the electronic data…

Manual result transcription without verification during data review – remediation failure analysis

The initial discovery of the deviation began when Quality Control (QC) personnel noticed an unexpected discrepancy during routine product testing. Specifically, the analytical results recorded for a batch of product…

Uncontrolled spreadsheet calculations during FDA inspection – 483 observation breakdown

During a routine internal audit preceding the FDA inspection, several symptoms were identified that indicated potential issues with data integrity relating to spreadsheet use:Click to read the full article.

QA oversight failure in DI during system validation – warning letter risk explained

Detection of QA oversight failures typically manifests during system validation in various forms. Here are some common symptoms observed on the floor or in laboratories:Click to read the full article.

QA oversight failure in DI during system validation – remediation failure analysis

During a routine review of the system validation process for a data management platform, the Quality Assurance (QA) team observed anomalies in electronic records management. Key symptoms that raised concerns…

Uncontrolled spreadsheet calculations during data review – warning letter risk explained

The cycle of uncontrolled spreadsheet calculations began when the quality control (QC) team noticed discrepancies in report summaries during a routine review of batch release data. Multiple entries in Quality…