Damla Varol

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...

Medical Device Development Phases According to Regulations Medical device development is an inherently complex process with increasingly rigid requirements that must be met for FDA approval and/or EU MDR compliance.

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...

Concept of Quality Culture 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 d...

Over the past few years, the life science industry has undergone meaningful growth and change. So what should you expect in 2023? The pharmaceutical and med-tech industries have adapted, innovated, and are expected to undergo a sea of change in the y...

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...

What is DMAIC? DMAIC is an acronym for Define, Measure, Analyze, Improve and Control. The DMAIC process is the quality improvement methodology of Six Sigma that’s used for improving existing processes. It is an integral part of a Six Sigma approach, ...

Corrective and Preventive Action (CAPA) management is a vital process of any Quality Management System. CAPAs are the necessary steps that must be taken to eliminate causes of non-conformities or other undesirable situations and lie at the heart of p...

Deviations and nonconformities, as all QA professionals know, are at the very heart of quality management. Detecting them is fundamental in preventing quality issues, and paves the way to improvement. However, preventing deviations and nonconformitie...

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...

Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...

The objective of a QMS is to define and formalize a system that documents processes, procedures and responsibilities for achieving quality policies and objectives. It basically provides the structure for various functions within an organization to wo...