Deviation Case Studies – Page 17

QA oversight failure in DI during system validation – 483 observation breakdown

The onset of the issue was marked by unusual discrepancies in batch records across multiple runs of a critical drug product. Operators began reporting inconsistencies between electronic data captured in…

Backdated laboratory records during FDA inspection – warning letter risk explained

The laboratory in question was subjected to an FDA inspection after several unusual signals presented on the production floor and within the quality control department. Key symptoms included:Click to read…

Shared analyst passwords detected during internal audit – warning letter risk explained

During the internal audit, several signals indicated underlying issues with data integrity and security compliance:Click to read the full article.

Uncontrolled spreadsheet calculations during FDA inspection – remediation failure analysis

During a routine FDA inspection, several warning signals emerged that suggested potential data integrity issues. First, discrepancies were noted between the calculated figures in spreadsheets and the corresponding results documented…

Backdated laboratory records during internal audit – 483 observation breakdown

Detecting anomalies in laboratory practices is often the first sign that deeper issues may exist. In our case, the symptoms signaling potential data integrity breaches included:Click to read the full…

Shared analyst passwords detected during system validation – 483 observation breakdown

During the FDA inspection, various signals indicated a potential failure in data integrity protocols. Analysts were found to be utilizing shared passwords to access the system. This practice undermined the…

Repeat DI lapses tolerated during data review – remediation failure analysis

The investigation began when several discrepancies in data entries were noted during routine audits of batch records and laboratory data sets. The symptoms included:Click to read the full article.

QA oversight failure in DI during data review – 483 observation breakdown

The initial symptoms of the issue were reported during routine data review sessions when an employee noticed discrepancies in recorded data entries versus the laboratory instruments’ outputs. Key indicators of…

QA oversight failure in DI during FDA inspection – 483 observation breakdown

During routine monitoring, discrepancies were noted in batch release data where the documented results did not match the raw data from electronic systems. Not only were discrepancies present, but they…

Repeat DI lapses tolerated during system validation – 483 observation breakdown

In early 2023, employees at a pharmaceutical manufacturing site began noticing discrepancies in the data collected during system validation processes. Frequent instances of data entry errors were reported, particularly in…

Audit trail deletion identified during data review – warning letter risk explained

Case Study: Understanding and Addressing Audit Trail Deletion During Data Review In a recent audit of a pharmaceutical manufacturing facility, inspectors identified a concerning issue: the deletion of critical audit…

Uncontrolled spreadsheet calculations during system validation – remediation failure analysis

When cross-functional teams involved in validation activities discovered anomalies, including unexpected or incorrect system performance, symptoms on the manufacturing floor quickly emerged. Employees noted discrepancies between validation reports and the…