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. It’s owned and ma...

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 more important than ever.

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 orga...

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...