Real-World Documentation Errors in Pharma: Lessons from the Shop Floor
Documentation errors in pharma are the most common reasons for audit observations. These errors may occur even…
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February 2, 2026
Learn how to prepare for internal and external audits, handle observations, and build a strong culture of compliance in pharmaceutical settings.
USFDA Audit Process in Pharmaceuticals
The USFDA audit process, also referred to as an FDA inspection, is a structured, risk-based, on-site examination…
January 30, 2026
ALCOA Principles in Pharmaceuticals
ALCOA principles are the foundation of data integrity in the pharmaceutical industry. Every test result, record, and…
January 27, 2026
What Does the USFDA Say About Metadata?
As the pharmaceutical industry moves toward digital records and electronic systems, the USFDA has clearly explained what…
December 29, 2025
10 Habits That Prevent Errors in Documentation in Pharma
Documentation in pharma is not just about filling formats or completing records. It is about proving that…
December 22, 2025
Pharmaceutical Documentation: Documented But Not Performed
If documentation does not match reality, it defeats the entire purpose of GMP. This principle becomes extremely…
December 16, 2025
Pharmaceutical Audits: How to Manage Stress During Audits?
Ravi is working as a Quality Assurance Manager with over 15 years of experience in the pharmaceutical…
August 9, 2025
What Is FDA 483 Observation?
In the pharmaceutical world, one term that often causes concern and yet is essential to understand is…
July 31, 2025