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 […]

How triaging customer issues can help you streamline CAPA management

How triaging customer issues can help you streamline CAPA management

Posted on Posted in Electronic QMS, JIRA

The information revealed through a CAPA process can lead to real customer and business benefits. On the other hand, triggering too many CAPAs creates unnecessary noise, burdens the CAPA management team and can pull resources away from more important activities. Triaging customer issues to determine which ones warrant starting a corrective and preventive action (CAPA) […]