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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 Add into the mix an outdated paper-based Quality Management System (QMS), and the task to meet regulatory requirements across multiple locations in an efficient, cost-effective, timely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...
What you should ask yourself before building a quality management system
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 fail/have already failed an audit. Our business is growing, and the existing QMS is too complicated for our expanding team. We already use Confuence and JIRA, and moving our QMS over will make things easier, more collaborative, and more engaging. We need a solution that...
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