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pharma
Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.
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...
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
Pharma 4.0 is a framework for incorporating digital strategies into pharmaceutical manufacturing contexts. This framework envisions a manufacturing paradigm that allows manufacturers to change and iterate, connect resources and workers, simplify comp...
In the history of civilization and economic development, several industrial revolutions have brought about profound paradigm changes in society, economics, and culture, reshaping industries, creating new opportunities, and raising living standards fo...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.
What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...
Regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are undergoing significant changes to meet the challenges and opportunities posed by this technology.
The pharmaceutical industry is rapidly evolving, and the number of AI application integrations is increasing day by day, reshaping every facet of pharmaceutical processes from drug discovery to supply chain management.
This is a story of triumph over tragedy. A story shaped by pivotal events that stress the importance of regulatory oversight in the production of pharmaceuticals and other medical products. This is the story of how the Good Manufacturing Practices (G...
medical devices
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 your medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regu...
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...
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 at the forefront of regulatory development and in...
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.
The world of medical devices is steeped in regulations - you can't say medical devices without saying compliance. In this world of medical device regulations, compliance is critical. It ensures the safety and efficacy of products entering the market ...
While sometimes deprioritized, regulatory compliance is critical for medical device manufacturers. And among the global regulatory frameworks, the Medical Device Single Audit Program (MDSAP) has gained prominence over the past decade. MDSAP is a comp...
Having the FDA knocking on your door for medical device inspections is scary! But the management of FDA inspections for medical devices is a critical aspect of ensuring compliance with regulatory standards and maintaining the integrity of the medical...
The United States Food and Drug Administration (FDA) is the regulatory body responsible for the safety and efficacy of medical devices in the United States. The 510(k) clearance is their classic premarket clearance for Class II medical devices that m...
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compliance
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...
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
Navigating the complexities of FDA inspections is crucial for QA professionals in the pharmaceutical and medical device industries. The stakes are high, with regulatory compliance directly impacting your organization's ability to operate smoothly, av...
In the highly regulated pharmaceutical and medical device industries an electronic Quality Management System plays a pivotal role where you can create, store, retrieve, and archive all of your company’s quality-related documents. Those activities ens...
Medicinal products and medical devices should be manufactured at a high level of quality to ensure they are fit for purpose. Manufacturers must also ensure patients are not at risk due to inadequate product quality.
In the era of Quality 4.0, cloud cybersecurity has become a crucial concern for businesses. Many companies are exploring the impact of switching from on-premise Quality Management Systems (QMS) to cloud-based QMS. It is important to understand the di...
Root Cause Analysis (RCA) is a systematic process used to identify the underlying cause or causes that lead to a problem or incident, with the goal of preventing its recurrence in the future. It is a systematic approach employed in various industries...
Ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11 is crucial for any Life Sciences company using computerized systems in this highly regulated landscape. Both 21 CFR Part 11 and EU GMP Annex 11 act as safeguards for the Quality, integrity, ...
We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.
ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.
quality management
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 your medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regu...
Information runs the world, and in healthcare, every bit of data is important. Every day, hundreds of sets of data are produced as people go about their jobs manufacturing medical products. Every day, almost all of this data is recorded in some way.
A narrow focus on regulatory compliance can hinder organizations from fully embracing and benefiting from quality and operational excellence.
Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.
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...
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
Navigating the complexities of FDA inspections is crucial for QA professionals in the pharmaceutical and medical device industries. The stakes are high, with regulatory compliance directly impacting your organization's ability to operate smoothly, av...
The In Vitro Diagnostic Regulation (IVDR) has ushered in a new era of stringent requirements for manufacturers of in vitro diagnostic (IVD) medical devices. Compliance with the regulation is imperative to ensure the safety and efficacy of IVD product...
Most pharma and medical device companies are increasingly adopting electronic Quality Management Systems (eQMS) to streamline their quality management processes. A well-designed quality management system helps you to meet customer satisfaction and re...
Audits and inspections are a part of the quality management lifecycle, they are simply a fact of life in the medical device and pharmaceutical industry. The purpose of an inspection of Quality Management Systems is to ensure your company has establis...
