Tag: CFR Part 11

Handling Anonymous Changes in Stability Databases

One of the most overlooked but critical challenges in pharmaceutical stability testing is the handling of anonymous changes in databases. Such modifications, if left untracked, pose a serious threat to data integrity and can result in regulatory non-compliance. In this tutorial, we explore how pharmaceutical professionals can identify, prevent, and document unauthorized or anonymous changes…

Best Practices for Stability Testing Data Integrity, Pharmaceutical Quality and Practices

Reviewing Audit Trails for Completeness and Accuracy

🔍 Understanding the Role of Audit Trails in Stability Testing Audit trails are a critical feature in computerized systems used for stability studies. They provide a secure, time-stamped record of who performed an action, what was changed, and why. Ensuring their completeness and accuracy is essential for regulatory compliance and data integrity under USFDA and…

Best Practices for Stability Testing Data Integrity, Pharmaceutical Quality and Practices

FDA Guidance on Data Integrity for Stability Testing

Data integrity continues to be a top concern in FDA inspections across pharmaceutical facilities. Especially in stability testing, where long-term data supports product shelf life and regulatory claims, ensuring reliable and traceable data is crucial. This article explores the FDA’s guidance on data integrity and how pharma professionals can align their stability testing operations to…

Best Practices for Stability Testing Data Integrity, Pharmaceutical Quality and Practices