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 […]

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 […]

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 […]