Deviation Case Studies – Page 20

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.

Shared analyst passwords detected during FDA inspection – 483 observation breakdown

During the FDA inspection, several symptoms indicated a potential breach in data integrity at the facility:Click to read the full article.

Manual result transcription without verification during FDA inspection – 483 observation breakdown

The FDA inspection revealed several key symptoms indicative of procedural failures. These symptoms suggested a lack of adherence to regulatory compliance and data integrity standards:Click to read the full article.

Backdated laboratory records during FDA inspection – remediation failure analysis

The first indication that a company might face issues with backdated laboratory records comes from various symptoms exhibiting themselves on the manufacturing floor or within the laboratory. These signals may…

Shared analyst passwords detected during system validation – remediation failure analysis

The first indicator of the data integrity breach emerged during a routine audit of user accounts in the laboratory information management system (LIMS). Anomalies were observed when multiple analysts were…