by Dr. Yashashwini Reddy | Sep 9, 2025
🔐 Why Data Integrity is More Important Than Ever? 1. Patient Safety at the Core Medicines are only as safe as the data proving their quality. Any falsified, incomplete, or inaccurate record may lead to unsafe products reaching patients. Strong data integrity ensures...
by Dr. Yashashwini Reddy | Sep 8, 2025
Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals Data integrity is not only about systems and SOPs, but also about people’s mindset, culture, and daily behaviors. Even the best electronic systems and QMS can fail if employees lack the...
by Dr. Yashashwini Reddy | Sep 8, 2025
A Brief Description of the Entire Audit Process in Pharmaceuticals Audits in the pharmaceutical industry are essential for ensuring compliance with cGMP, regulatory requirements, and internal quality standards. They help identify risks, gaps, and opportunities for...
by Dr. Yashashwini Reddy | Sep 8, 2025
Data Integrity – A Major Problem in Pharmaceuticals Data integrity has become one of the most critical issues in the pharmaceutical industry, directly impacting patient safety, product quality, and regulatory trust. Regulatory agencies like the FDA, EMA, and MHRA...
by Dr. Yashashwini Reddy | Sep 8, 2025
Trends in GMP Violations in Pharmaceuticals Good Manufacturing Practice (GMP) violations remain one of the leading causes of FDA 483s, Warning Letters, and drug recalls. Recent inspection trends show recurring compliance gaps across global pharma companies: 1. Data...
