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pharma
In the life sciences, compliance is everything, and two of the most critical regulations are Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP).
We all know that pharma companies are duty-bound to control the quality of the drugs they produce—it's paramount for protecting patient safety. One critical part of how they do this is by employing a Corrective and Preventive Action (CAPA) system.
Navigating the EU's pharmaceutical regulations can be a real head-scratcher. But there is one set of guidelines that you absolutely need to know if you are involved in manufacturing medicines in Europe. It is called EudraLex.
As one of the most regulated industries on the planet, the challenges in the pharma industry are countless, especially when it comes to managing a pharmaceutical Quality Management System.
If you’ve ever been through an audit in the life sciences industry, you know how important Corrective and Preventive Actions (CAPAs) are. Regulatory bodies expect you to have a strong CAPA process in place to uphold product quality and patient safety...
Every Quality Assurance (QA) professional knows that a Quality Management System (QMS) is the foundation of product safety and effectiveness in the pharmaceutical industry.
In the pharmaceutical industry, ensuring the safety and quality of medicines is a big responsibility. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the two most influential regulatory agencies overseeing drug...
Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...
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...
Good Manufacturing Practices (GMPs) have been the cornerstone of quality assurance in pharmaceuticals and medical devices for decades. These guidelines ensure that every product, from medicines to medical devices, is consistently produced and control...
medical devices
In the ever-evolving world of healthcare, Laboratory Developed Tests (LDTs) have emerged as critical tools for diagnosing a wide array of medical conditions. These tests, created and used by individual laboratories, are instrumental in everything fro...
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...
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...
You’ve finally received your 510(k) clearance and feel ready to start commercialization in the US market. But how do you go about importing medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regulator...
It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...
The Internet of Medical Things (IoMT) is revolutionizing the MedTech industry by integrating medical devices, wearables, and health applications through Internet connectivity. This transformation enables continuous health monitoring, real-time data e...
Looking to get CE approval for medical devices? Navigating the regulatory landscape is essential for medical device manufacturers aiming to market their products in Europe. As one of the most important regulatory markets in the world, the EU stands a...
Keeping track of medical devices is paramount to ensure the safety of patients. Traceability allows manufacturers to identify, trace, and control medical devices and is necessary for several reasons, chief among them regulatory compliance.
The prime directive of medical device manufacturers is the continued safety of patients through safe and effective medical devices. A critical aspect of medical device safety is ensuring regulatory compliance of any medical device destined for the co...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.
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compliance
In the life sciences, compliance is everything, and two of the most critical regulations are Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP).
Getting through an ISO audit is one of the most important defining moments for any life sciences company. Whether you’re manufacturing pharmaceuticals, developing medical devices, or working in biotech, these audits are how regulators and customers c...
We all know that pharma companies are duty-bound to control the quality of the drugs they produce—it's paramount for protecting patient safety. One critical part of how they do this is by employing a Corrective and Preventive Action (CAPA) system.
Navigating the EU's pharmaceutical regulations can be a real head-scratcher. But there is one set of guidelines that you absolutely need to know if you are involved in manufacturing medicines in Europe. It is called EudraLex.
In the pharmaceutical industry, ensuring the safety and quality of medicines is a big responsibility. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the two most influential regulatory agencies overseeing drug...
Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...
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...
Quality management software is gaining traction as a dependable adjunct to quality management teams. The benefits are substantial, especially in life sciences, where quality translates to rapport and, subsequently, sales. This growing reliance on qua...
quality management
Standard Operating Procedures (SOPs) are the backbone of quality management systems in the life sciences industry. Whether you're working in pharmaceuticals, medical devices, or biotechnology, SOPs ensure consistency, compliance, and safety in proces...
If you’ve ever been through an audit in the life sciences industry, you know how important Corrective and Preventive Actions (CAPAs) are. Regulatory bodies expect you to have a strong CAPA process in place to uphold product quality and patient safety...
Every Quality Assurance (QA) professional knows that a Quality Management System (QMS) is the foundation of product safety and effectiveness in the pharmaceutical industry.
In the pharmaceutical industry, ensuring the safety and quality of medicines is a big responsibility. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the two most influential regulatory agencies overseeing drug...
In the life sciences industry, a robust Quality Management System (QMS) is all-important for achieving compliance, sustaining operational efficiency, and safeguarding public trust. A QMS underpins every aspect of quality control, from adhering to str...
In the fast-paced and highly regulated life sciences sector, maintaining an effective Quality Management System (QMS) is critical to ensuring product quality, compliance, and continuous improvement.
Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...
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...
