Insight and opinion

Anticipating Innovation and Excellence at VALIDATE 2024

In the rapidly evolving landscape of validation, the VALIDATE 2024 conference stands out as a beacon for validation, quality, and…

Five In-Demand Skills for Validation Professionals in 2024

In the dynamic landscape of the validation industry, staying ahead of the curve is essential for professionals looking to thrive…

7 Reasons Why You Should Love Your Validation Team

In industries characterized by stringent regulations and high stakes, such as pharmaceuticals, medical devices, biotechnology, and consumer health, the importance…

CSV Testing: What You Need to Know

You can’t have validation without testing. It’s the cornerstone of ensuring reliability and functionality and, for regulators, the testing process…

Demystifying Computer Software Assurance

Life sciences organizations rely on computer systems to ensure the safety and quality of therapies, medical devices, and other products…

Mastering IQ, OQ, PQ, and PPQ

In regulated industries such as pharmaceuticals, biotechnology, and medical devices, ensuring product quality and compliance with industry standards is paramount….

What Is Computer System Validation?

If you work in quality, validation, IT, or engineering within the life sciences industry, chances are you’ve heard of Computer…

The Power of Continuous Process Verification in Manufacturing

In the ever-evolving landscape of manufacturing, staying at the forefront requires a commitment to innovation and adaptability. Continuous Process Verification…

The U.S. FDA Will Be Expanding the Use of Remote Regulatory Assessments

During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) needed to adapt to health recommendations like facility closures…

Understanding Quality by Design

Understanding Quality by Design Highly regulated manufacturers must prioritize precision and quality. To do this, they must rely on rigorous…

Top 3 Goals for Validation Professionals in 2024

As we step into 2024, the validation landscape is evolving rapidly, shaped by technological advancements, changing regulatory environments, and the…

Kneat 2023: Year in Review

As the calendar turns its pages, it’s time to reflect on the remarkable journey that was Kneat’s 2023. This year…

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