Scilife Blog

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...

Nobody knows the importance of 'Quality Records Management' better than a quality assurance professional! Quality records are invariably scrutinized in every internal or external audit. These documents are treated as living evidence of organizational...

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 ...

A fundamental part of safeguarding patients in Europe comes from ensuring that medical devices and in vitro diagnostics (IVDs) meet consistent, high regulatory standards. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation...

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...

Implementing a new eQMS raises questions that go far beyond software features. SaaS eQMS validation, documentation, ownership, and regulatory expectations all come into play.

The path to continuous improvement is well within research, and it starts with Quality by Design (QbD): a process that elevates product quality as a result of comprehensive risk management strategies.

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.

Staying ahead of industry shifts has never been more critical for anyone working in biotech, pharma, or MedTech. The pace of innovation is accelerating, regulatory expectations are tightening, and AI is reshaping everything from discovery to commerci...

When it comes to quality management, nothing should be left to guesswork. In the highly regulated life sciences industry, progress towards quality goals is often measured through quality-specific Key Performance Indicators (KPIs) known as Quality KPI...