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Post-Market Surveillance (PMS) for Medicinal Products

Medicines undergo rigorous testing, but safety doesn't stop there. Post-Market Surveillance monitors medications once in use, identifying unforeseen side effects, changes in effectiveness, and off-label use. This data allows for updated prescribing information, further studies, or even product recalls, ultimately safeguarding public health.
Learn how to create clear and comprehensive technical documentation for Medical Devices (MD) and In Vitro Diagnostics (IVD). Whether you're new to the industry or have experience, this guide will help you master the art of technical writing in these fields. Discover the essential practices and expert tips for creating impactful documentation in these critical industries.
Discover how to streamline technical documentation for medical devices and in vitro diagnostic products in our insightful blog series. Part 1 delves into transforming complexity into clarity, paving the way for compliance in a dynamic regulatory landscape.
Periodic reviews are conducted throughout the operational life of computerized system to verify that it remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures. The review should confirm that operational controls are in place and are being effectively applied.
For medical devices, where minor flaws endanger lives, a strong supply chain risk plan is essential. It prioritizes patient safety by mitigating risks like faulty parts or counterfeits and shows compliance with regulations.
In Computer System Validation, GAP assessment serves to pinpoint differences between a company's existing procedures, practices, and policies and relevant regulatory guidelines and compliance standards. It involves gathering evidence to delineate the variance between requirements and current strengths.
Uncover the transformative impact of smart monitoring solutions on the pharmaceutical industry, optimizing operations and driving efficiency. Explore the essential role of environmental monitoring in upholding quality standards and regulatory compliance within pharmaceutical manufacturing processes.
In the pharmaceutical industry, ensuring product quality is paramount. Rigorous environmental monitoring plays a critical role in maintaining this quality by preventing contamination and achieving regulatory compliance. This blog explores how environmental monitoring improves pharmaceutical product quality, with practical insights.