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 […]

Survey says: Proactive quality risk management for life science companies is a must

Posted on Posted in Electronic QMS, General, london_2018

Klavs Esbjerg, CEO and founder of Epista Life Science, is on a mission to help his clients continuously improve regulatory compliance and in turn, transform their compliance obstacles into real business opportunities. The practical aspects of this vision are as important to regulatory bodies as they are to the companies Epista serves. To get clear on […]

Why digitised design control is essential for the sustainability of your DHF

Posted on Posted in General, london_2018

Thanks to Laurence Sampson for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London, 3/10/2018) In today’s competitive landscape, every stage of the regulatory process – from first submission through ongoing, annual or semi-annual iterations – is a make-it- or break-it-scenario. From delays to audit failures and […]

The difference between data integrity & data quality in medical technology companies – and why you must care

The difference between data integrity & data quality in medical technology companies – and why you must care

Posted on Posted in General, london_2018

Thanks to Keith Williams for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London, 3/10/2018) Data is the lifeblood of any Life Sciences company – and trust is the heart. For those of us that manage data, we cannot and will not allow drugs or medtech […]

How Paperless Validation Makes a World of Difference to Your Medtech Company Success

How paperless validation makes a world of difference to pharma success

Posted on Posted in General

For many of the medtech and pharmaceutical companies I consult with, there’s a common clash of the validation systems “worlds” raging: traditional, “this is how we’ve always done it” paper documentation versus newer, tech-driven solutions. In order to effectively harmonize business processes company-wide, I argue that innovation is critical, as the challenge is not just […]

An in vitro diagnostics (IVD) medical device and clinical lab organization with offices in the U.S. and Europe desperately needed a new QMS to better manage a vast quantity of paperwork. Beyond the risk of non-compliance, it was a daily challenge to ensure that procedures were standardised and the latest documents were being referenced.

How we Saved a medical device company time, compliance headaches and money

Posted on Posted in Case studies, General, JIRA

For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely manner becomes impossible – and threatens to derail a busy, successful international organization for non-compliance.  The challenge  An in […]

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 […]

How to validate Software Development tools used for GXP and MedDev?

Validating software development tools used for GxP and MedDev

Posted on Posted in Confluence, Electronic QMS, General, JIRA

Compliance is a key consideration when using software tools in the context of: Development of software applications which are used for good practice (GxP) purposes Development of software and hardware embedded on medical devices (MedDev). Several standards and guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like […]