Deviation Case Studies – Page 18

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…

Audit trail deletion identified during system validation – warning letter risk explained

The initial detection of issues related to audit trail deletion surfaced through routine quality checks performed by the Quality Control (QC) team. Unusual patterns observed included:Click to read the full…

Manual result transcription without verification during internal audit – remediation failure analysis

The initial indications of the transcription issue were flagged during routine internal quality checks where discrepancies were noted between recorded results and original data entries. Team members reported:Click to read…

Shared analyst passwords detected during internal audit – remediation failure analysis

During the internal audit, several alarming symptoms were observed, indicating inadequate control over data access:Click to read the full article.

Shared analyst passwords detected during FDA inspection – warning letter risk explained

During the inspection, several alarming signs indicated a potential data integrity issue:Click to read the full article.

Backdated laboratory records during internal audit – warning letter risk explained

The initial signal indicating a potential breach of data integrity was an unusual discrepancy between the recorded results in laboratory notebooks and the electronic data system. These discrepancies were discovered…

Backdated laboratory records during data review – 483 observation breakdown

When laboratory records are backdated, various signals may indicate the issue, often presenting themselves subtly initially. Observations may include:Click to read the full article.