Deviation Case Studies – Page 19

Backdated laboratory records during data review – remediation failure analysis

During a routine bi-monthly data review, discrepancies were observed in laboratory records related to batch release testing. The quality control (QC) manager noted that some records appeared to have dates…

Shared analyst passwords detected during system validation – warning letter risk explained

In this case, the initial detection of shared analyst passwords was marked by several key symptoms:Click to read the full article.

QA oversight failure in DI during FDA inspection – warning letter risk explained

The initial triggering event in this case was an internal audit that uncovered inconsistent data entries in batch production records (BPRs). Symptoms included:Click to read the full article.

Repeat DI lapses tolerated during data review – warning letter risk explained

The detected symptoms of potential data integrity lapses manifested through anomalies observed during routine data reviews. Specific signs included:Click to read the full article.

Uncontrolled spreadsheet calculations during data review – remediation failure analysis

The initial cues indicating potential issues began with staff reports made during routine data review. Analysts noted unexplained variances in batch reports and discrepancies between spreadsheet outputs and registered data…

Audit trail deletion identified during FDA inspection – 483 observation breakdown

During routine data review prior to an FDA inspection, the Quality Assurance (QA) team detected significant discrepancies in the audit logs for a batch of sterile injectable products. Key symptoms…

Audit trail deletion identified during data review – 483 observation breakdown

The initial symptom of a data integrity breach often presents during routine data reviews. In this case, a Quality Control Analyst noticed irregularities when reconciling electronic batch records against physical…

Repeat DI lapses tolerated during FDA inspection – 483 observation breakdown

Symptoms of potential data integrity issues may surface gradually or suddenly, often during routine quality assurance checks or audits. Key indicators that suggest DI lapses include:Click to read the full…

Backdated laboratory records during system validation – remediation failure analysis

Detecting signs of backdated laboratory records is often the initial step in identifying potential data integrity issues. In this case, various symptoms prompted the investigation:Click to read the full article.

Shared analyst passwords detected during data review – warning letter risk explained

During a scheduled review of laboratory data logs, several discrepancies were noted in the entries of multiple analysts. These discrepancies included:Click to read the full article.

Shared analyst passwords detected during data review – remediation failure analysis

During a regular quality control audit, a series of unusual data entries were reported by the quality assurance team. The symptoms prompting further investigation included:Click to read the full article.

Repeat DI lapses tolerated during internal audit – warning letter risk explained

Symptoms of data integrity (DI) lapses can manifest in various ways. In this scenario, auditors observed several concerning signals:Click to read the full article.