INTRODUCTION: There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect to the design, implementation and… Continue reading Ensuring Data Integrity: Best Practices and Considerations
Category: Regulatory
The Road to FDA Success: Zenovel’s Insights and Expertise
The Road to FDA Success: Zenovel’s Insights and Expertise Preparing for FDA interactions can be daunting, filled with uncertainty and misconceptions. Sponsors often find themselves in the dark about what to expect when engaging with the FDA, which can lead to unnecessary stress and setbacks. At Zenovel, we understand the challenges that sponsors face, having… Continue reading The Road to FDA Success: Zenovel’s Insights and Expertise
How to Prepare Subject Matter Experts for FDA Inspections
Introduction Facing an FDA inspection can be a nerve-wracking experience for any pharmaceutical company. While many focus on logistics and documentation, one crucial aspect that should not be overlooked is preparing your Subject Matter Experts (SMEs) for the inspection. SMEs, who possess in-depth knowledge of your front-line operations, can unintentionally provide information that may harm… Continue reading How to Prepare Subject Matter Experts for FDA Inspections
Ace Your FDA Inspection with Zenovel
Ace Your FDA Inspection with Zenovel Understanding FDA Inspections Before we dive into the specifics of this blog, let’s take a moment to understand the significance of FDA inspections. The Food and Drug Administration (FDA) is responsible for safeguarding public health by ensuring that pharmaceutical manufacturers comply with strict regulations and guidelines. Routine inspections are… Continue reading Ace Your FDA Inspection with Zenovel