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 […]

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 […]