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Peering into the Future: What’s Next for Medical Device QA?

The landscape of medical technology is evolving at a rapid pace, and medical device quality assurance (QA) needs to evolve alongside it. Traditional methods are reaching their limits, and innovative technologies are stepping onto the stage.
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What is GAMP 5 Guideline? Checklist for GAMP 5 compliance

GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.
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Discover how to integrate AI Into Quality Management Workflows

The AI revolution brings unparalleled opportunities and challenges across all sectors, with life sciences and healthcare standing at the forefront due to their critical role in enhancing public health and quality of life. These areas hold immense potential for AI to make groundbreaking improvements but also face significant risks that cannot be ignored.
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Sustainability in medical device manufacturing: the growing importance of environmentally responsible practices and materials in the industry.

The Greening of Medicine: Sustainability in Medical Device Manufacturing The medical device industry, a vital contributor to patient care, often leaves a significant environmental footprint.
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5 Essential Steps to Effectively Respond to FDA Warning Letters

FDA warning letters typically follow inspections where deviations or violations of regulations, such as those related to data integrity are discovered. During inspections, auditors document these deviations using Form 483. While Forms 483 and FDA Warning Letters are distinct, the warning letter often follows as the next step in the regulatory process
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Unveiling GMP Inspections: Key Deficiencies and Guidelines

In the pharmaceutical industry, GMP inspections ensure quality and compliance, demonstrating commitment to safety and building trust with healthcare professionals and patients. Understanding the inspection process, guidelines, and common deficiencies is crucial for upholding industry standards and ensuring patient safety.
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Computer System Validation: Key Strategies for Compliance

Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.
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Mastering 21 CFR Part 11 Compliance: The Ultimate Guide

In the life sciences sector, aligning with 21 CFR Part 11 isn't just good practice—it's crucial. This regulation, part of the Code of Federal Regulations, ensures the reliability of electronic records and signatures for FDA-regulated entities like pharmaceuticals, medical device manufacturers, and biotech firms. Let's simplify what this means and how to stay compliant.
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