The Gist of Writing Better Read And Understood Training Docs

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Getting your team to confirm they’ve read and understood documents is only half the battle. Granted, it’s an important battle to win. It’s why we love getting feedback like this on our Read & Understood Training Genius app for Confluence: “It’s great — one of our developers was behind with 69 read & understood trainings. […]

Why the Way to a Hellish Quality System May Be Paved With Best Practices

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Standard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance. But oftentimes, the reality is different. Regulations and standards tend to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get […]

Getting started with the Read & Understood Training Genius App for Confluence

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Ensuring that your team is well trained and your company will pass compliance audits with flying colors is much easier with our new Read & Understood Training Genius App for Confluence. It empowers QA managers with greater control and time-saving automation — all that needs to be done is to set the training matrix rules […]

Why Confluence is the Perfect System for Read & Understood Training

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

If you work for a life sciences company, you know that the impact of a well-trained team is significant. Internally, it supports greater productivity, boosts job satisfaction and improves products for a healthy bottom line. Externally, the outside world benefits from safer, more accurate software and tools for user/patient wellbeing. Implementing a streamlined, intuitive, compliant […]

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 […]

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 […]

How to Easily Create a Compliance Table in Confluence

How to create a compliance table in Confluence

Posted on Posted in Confluence

When building a quality procedure that complies with a specific standard, a compliance table is a handy reference. It maps the standards’ sections to your procedures, and helps ensure that all requirements are met. As an added benefit, auditors love a compliance table. It gives them immediate access to answers about how you apply particular standard directives. […]

Writing clear SOPs is difficult because they serve two distinct audiences: your internal team that has to execute the procedures, and the auditor who reviews them to ensure compliance. The trick is to strike a balance in the content, style, and organisation so they're easily understood by anyone who reads them.

Four strategies to ensure your standard operating procedures are easy to read

Posted on Posted in JIRA

Standard Operating Procedures (SOPs) are necessary for any efficient system, and yet their effectiveness can vary widely based on how well – or not – the procedures are written. Writing clear SOPs is difficult because they serve two distinct audiences: your internal team that has to execute the procedures, and the auditor who reviews them to ensure compliance. […]