Damla Varol

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...

In life sciences, one of the most heard terms is non-conformity management or NC management. To utilize and maintain an ideal NC management process, first, you need to understand what it is for and what are the risks and costs if it doesn’t work prop...

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...

Life science industries have their language and it consists of many concepts, terms, and abbreviations that are commonly mixed up. When you see them together it is even harder to grasp the nuances between concepts. Today we’ll give you a long list of...

2023 is almost over. Oh how time flies! As we are entering the last quarter of the year, there are still plenty of conferences and trade shows for you to attend. These events are a great way to stay on top of today’s rapid and sometimes overwhelming ...

Managing your documents doesn’t have to feel like a never-ending nightmare. Good document practices, also known as GDocP, are essential to streamlining your document workflow, enhancing employee efficiency, and ensuring compliance with regulatory sta...

Did you know that 80% of Life Sciences companies are lagging behind in digitalizing their core business? For some, paper documentation is still piling up. For others, their new digital solutions are not yet fully utilized.

GMP stands for “Good Manufacturing Practices.” In life sciences manufacturing, a buzzword you'll often hear is "Good Manufacturing Practices," commonly known as GMP. But what exactly does it entail? This piece will outline the five main components of...

Corrective and Preventive Action (CAPA) is an essential component of quality management in the pharmaceutical and medical device industry. However, problems with the CAPA process can lead to regulatory action, product recalls, and, most importantly, ...

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to learn mor...

Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits so that your organ...

How much do you know about Medical Device Coordination Group Documents? You may be more familiar with their abbreviation: MDCG. Developed on behalf of the European Commission, MDCG Documents are designed to help manufacturers understand how the Medic...

Introduction to Audits An audit is the verification, inspection, or examination of a process, product, or system to guarantee compliance with regulatory or organizational requirements. The scope of an audit can apply to an entire organization or be l...

QA and QC processes are inseparable parts of the overall Quality Management System (QMS), and they are often used interchangeably. However, while these processes feature some overlap, it’s essential to note that they are two separate entities and tak...

A complex and multi-layered phenomenon, there is no single definition of quality culture. There are many ways to define this concept. However, the main content elements of organizational culture are summarized in Schein's definition.

What is Change Management? In order to keep up with rampant globalization, manufacturers face ever-increasing pressure to produce high-quality products faster and at lower costs. They continuously need to respond quickly to meet evolving customer dem...

Companies in the life sciences industry need to deal with stacks and stacks of documents. Whether they’re paper or digital, chaos is inevitable if documents are not kept meticulously organized. Document control software is frequently used in the life...