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 […]

Markus Roemer, in Stuttgart, puts order in the GXP regulatory landscape

Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev

Posted on Posted in Confluence, Electronic QMS, JIRA, Validation microsite

Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for expert insights on implementing and maintaining effective quality systems. Featuring presentations by four industry leaders, attendees left the conference with actionable information – regardless of if they were initiating a new system […]

Traceability in Jira

Traceability matrices

Posted on Posted in Electronic QMS, JIRA, Validation microsite

Without the right tools in place, traceability matrices can easily bring a project to the brink of collapse. Still today there are project managers who delay moving to production for a significant length of time while they put together a traceability matrix for the validation report. Fortunately, with the addition of appropriate plugins, Jira provides […]

RadBee Sophia Genetics Case Study

From Paper-Based to practical: How we digitised a paper-based QMS & ensured ISO-27001 compliance in just 5 weeks

Posted on Posted in Case studies, Confluence, Electronic QMS

An efficient quality management system (QMS) is the lifeblood of any company in the health industry. Failure to meet strict regulatory and compliance requirements could mean lost business or even a complete shutdown of operations. The challenge Biotech start-up SOPHiA GENETICS has had a QMS in place since its launch six years ago. VP of […]