Deviation Case Studies – Page 19

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

During a routine internal audit, several symptoms raised red flags concerning the integrity of laboratory records. These included: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

The initial detection of the issue began during a routine internal audit of the laboratory records. Observations made included:Click to read the full article.

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.

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.