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 […]

Why you should manage your requirements in Jira

Why you should manage your requirements in Jira

Posted on Posted in Electronic QMS, JIRA

Many of my customers are devoted fans of both Jira and Confluence. They use Jira for tracking their development tasks, defects, and often times some of their business processes. For documenting technical specifications they’ll commonly use Confluence. I am also a fan of both applications, but when it comes to managing requirement specifications within a formal […]

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 […]

Before you build a Quality Management System (QMS), it’s critical that you understand what is your key driver.

What you should ask yourself before building a quality management system

Posted on Posted in Confluence, Electronic QMS, JIRA

Before you build a quality management system (QMS), it’s critical that you understand what is your key driver. Over the years, here are some of the motives I’ve heard:   It’s a milestone for the next funding round. It satisfies regulatory requirements (i.e. CE mark, FDA approval). We’re “forced” to have one. We’re about to […]

Validating JIRA (or what we can learn from the use of Excel in regulated life sciences organisations)

Validating Jira

Posted on Posted in Electronic QMS, JIRA

(or what we can learn from the use of Excel in regulated life sciences organisations) Jira seems to be installed everywhere now. Typically, it begins with a grassroots initiative then its usage spreads almost virally, until a mid-level or senior executive realises that it has become essential to the running of the business. In life […]

How Confluence meets the needs of document users?

How Confluence meets the needs of document users

Posted on Posted in Confluence, Electronic QMS

When designing a controlled document management system, it’s important to take the requirements of everyone who may need to access the documents into account. That’s why mapping users’ needs through each stage of the controlled document lifecycle is a key element in each of our quality management projects. The list below shows how a document management […]