Damla Varol
QA Consultant, Scilife
With 14+ years of experience in medical device and pharmaceutical manufacturing, Damla is a QA RA Consultant known for her meticulous attention to detail and passion for quality standards. From working with the largest manufacturing companies to medical device start-ups, she has mastered ISO 9001, ISO 13485, MDD, MDR, and FDA CFR 21 Part 820 regulations. Applying her extensive expertise and skills, she offers practical compliance solutions and invaluable insights to help industry professionals achieve compliance excellence.
Most of the NIS2 Germany coverage I have read in the last six months came from law firms or IT consultancies. Much of it treats NIS2 as a standalone cybersecurity programme.
In highly regulated industries like pharma and biotech, organizations are typically well-versed in compliance and regulations. Yet as they scale, some quality systems begin to show cracks in ways that aren’t immediately obvious.
In my experience as a quality professional, I have found that a CAPA medical device system is the most revealing part of a company's internal structure. I once worked with a team that had nearly 40 open files, some dating back eighteen months, becaus...
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...
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...
Deviation in pharma is unavoidable, but how you detect, assess, and resolve deviation management in pharma is what protects patients and product quality.
Most pharmaceutical and medical device companies adopt an electronic Quality Management System (eQMS) to centralize and control quality processes, improve traceability, and support compliance with applicable regulatory frameworks, including ISO 13485...
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...
In the life sciences industry, the concept of quality transcends mere compliance and enters the domain of strategic business importance. The cost of quality, a pivotal communication tool, was profoundly emphasized by Philip Crosby, a titan in the qua...
Creating a culture of quality is paramount to success, especially in the fiercely competitive pharma and medical device industries. Having a strong quality culture allows you to spark innovation, foster seamless teamwork, and ensure compliance with r...
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, ...
CAPAs (or Corrective and Preventive Actions) don’t usually fail at implementation. Instead, they fail because no one checks whether the actions actually solved the problem. In pharma and life sciences, this is more common than it should be.
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...
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