Why the Way to a Hellish Quality System May Be Paved With Best Practices

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Standard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance. But oftentimes, the reality is different. Regulations and standards tend to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get […]

Why waste reduction is the #1 priority for QA & Compliance, according to experts

Posted on Posted in General

At a recent knowledge sharing and networking event in London, England, life science industry professionals gathered to glean insights from experts on the common challenges experienced in implementing effective quality systems. While there were many important points made, the one consistent takeaway was that the key to practical QA and compliance is the reduction of waste. This […]

How to validate computerised systems used for GxP and Medical devices environments. Computers system validation in an Agile age

Posted on Posted in General

8 February 2018, Stuttgart, Germany (9:00-17:00m)Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany In an age where computerised systems make the difference between winning and loosing, we need to find ways to continuously and relentlessly innovate our systems.  Today, compliance is no longer enough: we need a validation framework which helps the business move […]

Process mapping

Posted on Posted in Validation microsite

Whenever a new computer system is introduced or an old one updated, the goal is to better support one or more processes. For example, a document management system facilitates the process of authoring and approving documents while a service desk application streamlines the process of receiving and handling support requests. Before embarking on any project […]