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In the pharmaceutical industry, maintaining patient safety and product quality is not just a regulatory obligation, it’s an ethical imperative. Any oversight can lead to severe consequences, from product recalls to harm to patients, tarnishing reputa...

Pharmaceuticals are one of the most vital industries keeping the world running. Whether you are involved in the industry or not, the quality control and reliability of top drug companies affect everyone at some point.

When we observe the industry advancements, we see that software validation has become an indispensable yet challenging process. As regulations grow more stringent and technologies advance, the demand for smooth validation strategies is at an all-time...

A well-trained workforce is vital for the quality and safety of a product, particularly in the pharmaceutical industry, as well as other industries with strict regulatory requirements. Being “well-trained” means employees don’t just go through the mo...

The commercialization of medical devices and drugs depends on a single aspect – patient safety. Patients must know that the device or drug does what it is supposed to do and won’t unintentionally harm them. Enter, quality management. Quality manageme...

A week of intensive United States Food and Drug Administration (FDA) inspection has just concluded for your team, and while there’s a cautious sense of relief, there’s still that persistent concern.

The right electronic Quality Management System (eQMS) can help strengthen your compliance processes and build a culture of quality within your organization. Discover the eight best quality management software and learn how to choose the right one for...

The modern medical life science industry is a multiple-wheeled machine. It takes a lot of groups working in tandem to get a medical product on the market. While the majority of the production and assembling might happen in the manufacturing facilitie...

As the life sciences industry becomes increasingly regulated and competitive, quality management has become more vital than ever. Are you confident in your organization’s Quality Management Maturity (QMM)?

4 min read.

Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates indepen...

5 min read.

In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality management system. Companies design and/or develop products every day to improve their existing produ...

On November 25, 2020, the European Commission adopted the pharmaceutical strategy for Europe, an initiative that aims to transform the pharmaceutical landscape in the European Union.

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