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pharma

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.

5 min read.

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...

5 min read.

Before a drug is suitable for patients, it must pass rigorous testing and cost-benefit analyses. In this post, we will discuss the journey a new medicinal product must take from the lab to final authorization in the EU. Continue reading this post to ...

5 min read.

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.

8 min read.

The pharmaceutical industry has a responsibility to prioritize sustainability, but unfortunately, it has not always done so in the past. At present, sustainability is often viewed as a trendy buzzword, used by companies to improve their public image ...

medical devices

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...

Quality management is the foundation of medical device manufacturing, as it interlinks with every aspect of the process, from design and development to post-market surveillance. Quality management systems (QMS) are deeply entrenched in the industry a...

5 min read.

Medical devices are a vast category of equipment, treatments, and functional aids, ranging from caries detection software to contact lenses, orthopedic implants, respiratory care, and more. Every person will need a medical device at some point or ano...

6 min read.

Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in an...

compliance

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...

5 min read.

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, ...

5 min read.

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.

7 min read.

ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.

4 min read.

While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...

The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US...

Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulato...

quality management

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...

A quality audit is an inseparable part of the life sciences business. This is because healthcare products can have desired as well as undesired effects on patients. Therefore, it is important to manufacture them by following the best practices in the...

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 ...

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...

According to the U.S. Food and Drug Administration (FDA), data integrity is the completeness, consistency, and accuracy of data. The agency places a significant emphasis on data integrity in regulated industries such as pharmaceuticals, biotechnology...

An eQMS is a digitalized Quality Management System where you can create, store, retrieve, and archive all of your company’s quality-related documents. In the context of a life sciences company, an eQMS also automates compliance requirements under 21 ...

If you’ve been on the lookout for a go-to resource offering valuable tips for technical writing, your search is finally over. We’re here to simplify complexity.

Quality can help organizations drive compliance and growth, as well as reduce costs, by shifting from being an operational compliance issue to a strategic business initiative.

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