Scilife Blog

Why GAMP 5 Needed a 2nd Edition GAMP 5 (Good Automated Manufacturing Practice) is a risk-based approach for the implementation, operation, and validation of GxP Computer Systems in regulated industries – including the Life Sciences. Recent technologi...

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...

What Is a Non-Conformance Report? A non-conformance report is a document that explains a deviation from the anticipated outcome of a process or product. Some examples of events in the Life Sciences that may call for a non-conformance report are:

As the life sciences are digitalizing at an unprecedented scale and rate, data lifecycle management is becoming increasingly important. The two major factors driving this rapid and close-to-universal digitalization are Industry 4.0 and the COVID-19 p...

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 ...

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...

The path to continuous improvement is well within research. It starts with Quality by Design (QbD): a process that elevates product quality as a result of comprehensive risk management strategies. This article will outline what Quality by Design enta...

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...