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...
Recently, our Scilife CEO Filip invited Mika Siitonen, Medical Development Manager at Labquality and seasoned expert in medical device regulatory guidelines, to answer anything and everything you wanted to know about performing Risk Management under ...
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...
GMP stands for “good manufacturing practices.” Life Sciences companies need to be GMP-certified in order to produce and sell their products. But what do GMP guidelines entail? And how is GMP different from cGMP, or “current good manufacturing practic...
What are SaaS solutions? Software as a service (SaaS) solutions allow users to easily connect to and use cloud-based apps over the internet instead of having to install software on the user's local computer. Common examples include email services, ca...
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...
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...
As forward-thinker management guru, Peter Drucker, once famously stated, “If you don’t measure it, then you can’t improve it.” After all, how will you know if something is better without comparison? Therefore, if you want to track your company’s stra...
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...
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