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Agile and design controls: From story to specifications
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 working with many teams that are "Agile first," I have seen firsthand how easy it is for people to believe that Agile stories are the same as specifications. Not only are they not the same, but also the difference is critical to how you work...
Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev
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 or improving an existing one. Given the focus on QMS sustainability and overall efficiency, the presenters illuminated their points with real-world examples of systems that are compliant but not...
How we Saved a medical device company time, compliance headaches and money
For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely manner becomes impossible – and threatens to derail a busy, successful international organization for non-compliance. The challenge An in vitro diagnostics (IVD) medical device and clinical lab organization with offices in the U.S. and Europe desperately needed a new QMS to better manage a vast quantity of paperwork....
Traceability matrices
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 an excellent solution. Using it to manage your specifications and tests will eliminate the need for tedious manual work by integrating traceability throughout every stage of the project. As user requirements and other elements emerge and...
How to validate computerised systems used for GxP and Medical devices environments. Computers system validation in an Agile age
8 February 2018, Stuttgart, Germany (9:00-17:00m)Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, GermanyIn an age where computerised systems make the difference between winning and loosing, we need to find ways to continuously and relentlessly innovate our systems. Today, compliance is no longer enough: we need a validation framework which helps the business move quicker and release often.In this one day conference we will explore the newest trends in computers system validation (CSV). Experts will share perspectives on standards and guidelines for setting up a CSV...
From Paper-Based to practical: How we digitised a paper-based QMS & ensured ISO-27001 compliance in just 5 weeks
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 Quality Jasmine Beukema and her team work hard to ensure that SOPHiA has always met the medical device industry’s strict standards. But what began as a six-person company that could easily operate with a paper-based system had since grown to 150. From...
Planning for validation
Planning your project and planning your validation are very closely intertwined and, when your project process is mature, these will converge to become one thing. Our focus here though is on the importance of allowing time in your project plan to make sure all the validation boxes are ticked. Whether you run your project using Waterfall or Agile methodology, the validation outline will be largely the same. This is the list of validation elements you should have ready by the time the project moves to production: Element Typically is documented in What this is 1 Plan Validation plan The plan...
Why you should manage your requirements in 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 framework of traceability, Jira is superior. When I ask people why they chose Confluence for that purpose, the answers have more to do with perception than reality. For example, they look at the layout of a Jira issue and assume it...
Validating software development tools used for GxP and MedDev
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 ISPE GAMP, ISO 12207, IEC 62304, CMMI and AAMI TIR45:2012. The basic principles are common to all these approaches: Release management and requirements engineering, specifications and configuration management,...
How to create a compliance table 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. I will show you how to use Confluence to easily build a low maintenance compliance table that does the following: Accurately reflects your current documents and eliminates inconsistencies (i.e. a document that no longer exists, an...
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How Agile Teams Can Avoid Being Victims of Their Post-it HabitsAs an eQMS specialist who frequently works with agile teams, I often walk away from meetings thinking, “Boy, do I wish I owned stock in 3M, the original makers of post-it notes!” While post-its are famously used for design sprints, their versatility makes them a naturally powerful brainstorming tool for agile teams. It was at […]
The Gist of Writing Better Read And Understood Training Docs, Part 2Read & Understood trainings are known both for what they do well — demonstrate compliance to auditors — and also for what they do not do so well: truly train employees. The truth is there’s no reason that you can’t achieve both goals by making it quick and easy for trainees and auditors alike to […]
What does eQMS success looks like?A successful eQMS project is not simply about replacing a legacy tool with a shiny, cool new one. It’s also not solely about achieving regulatory compliance. While those are positive outcomes, they’re not the point of evolving your quality system. Just like smart phones weren’t only an upgrade of the dial telephone and commercial flights […]
The Gist of Writing Better Read And Understood Training DocsGetting 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 PracticesStandard 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 […]