Deviation Case Studies – Page 16

Audit trail deletion identified during system validation – 483 observation breakdown

Audit trail deletions can manifest in various ways, and it is essential to remain vigilant for symptoms that may indicate a breach in data integrity. In this case, the following…

Uncontrolled spreadsheet calculations during internal audit – warning letter risk explained

During a routine internal audit, the quality assurance team at PharmaX Inc. identified several discrepancies in reported yield calculations for a key product. The symptoms included:Click to read the full…

Backdated laboratory records during internal audit – remediation failure analysis

Remediating Backdated Laboratory Records: A Comprehensive Failure Analysis In pharmaceutical manufacturing, maintaining integrity in laboratory records is essential for regulatory compliance and trust in the quality of products. This article…

Repeat DI lapses tolerated during internal audit – remediation failure analysis

The scenario began when a pharmaceutical manufacturing facility started to receive complaints from Quality Control (QC) about discrepancies in batch records and analytical results. A total of five internal audits…

QA oversight failure in DI during FDA inspection – remediation failure analysis

During the FDA inspection, several symptoms indicated discrepancies in data integrity, including:Click to read the full article.

Backdated laboratory records during system validation – 483 observation breakdown

Typically, the first signal of a potential data integrity issue arises from unexpected findings during routine audits or system validations. In this particular case, operators noticed discrepancies concerning the dates…

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…