Why Confluence is the Perfect System for Read & Understood Training

Posted on Posted in Confluence, Electronic QMS

If you work for a life sciences company, you know that the impact of a well-trained team is significant. Internally, it supports greater productivity, boosts job satisfaction and improves products for a healthy bottom line. Externally, the outside world benefits from safer, more accurate software and tools for user/patient wellbeing. Implementing a streamlined, intuitive, compliant […]

More Quality, Less Bureaucracy: How QA Managers Can Streamline Read & Understood Training in Confluence

More Quality, Less Bureaucracy: How QA Managers Can Streamline Read & Understood Training in Confluence

Posted on Posted in Confluence, Electronic QMS

In my work with Life Sciences companies, I’ve found that most companies today use Read & Understood training extensively. In theory, this simplifies initiating new team members and keeping your existing staff up-to-date. No quizzes or tests to create; all QA managers have to do is publish a document and send it to those who […]

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 […]

Agile for GXP and Medtech

Agile for GXP and Medtech

Posted on Posted in Electronic QMS, JIRA

These are exciting times to serve the life sciences sector – thanks to technological advances, innovations abound and progress marches on at a lightening-fast clip. Working with a wide variety of organisations, I see two very different types of teams searching for an answer to the same fundamental question: “How do I best do Agile […]

It's valid to want to automate inefficient systems, and more than that, it's actually imperative. The companies that master the regulatory and technical challenges of hands-free validation today will steer their way clear to competitive advantage tomorrow.

Heading toward hands-free validation

Posted on Posted in Electronic QMS, JIRA, Validation microsite

Over the course of working with dozens of innovative, exceptional companies, I’m always struck by their commonalities of purpose and process. While they all are creating products poised to help us all live happier, healthier and more productive lives, ironically enough many tend to put themselves through sadly torturous, inefficient circumstances before their products can […]

In order to strike the balance, you must understand the difference between "stories" (Agile term) and "specifications" (Design Controls term).

Agile and design controls: From story to specifications

Posted on Posted in Electronic QMS, JIRA, Validation microsite

Doing Agile in a GXP or medical devices environment requires you to serve two masters: you need to practice the Agile disciplines on one side, and embrace regulatory requirements on the other. In order to strike the balance, you must understand the difference between “stories” (Agile term) and “specifications” (Design Controls term). From my experience […]