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How Confluence meets the needs of document users?
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...
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Adjusting JIRA for FDA CFR 21 part 11 compliance: managing deletion
Regulations dictate that controlled records should be managed in compliance with the FDA CFR 21 part 11 (aka Part 11) guidelines. Part 11 defines the criteria under which the US Food and Drug...
View ArticleCompliance, JIRA Core and the Atlassian Cloud
When companies first contact us to discuss how we can help them, many ask whether it’s possible to implement their electronic quality management system (eQMS) process in JIRA Core in the Atlassian...
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Transforming your CAPA SOP with JIRA Core – an action plan
This post outlines the steps involved in setting up a quality management system (QMS) process in JIRA Core. QMS standard operating procedures (SOPs) are all about process management, which is what JIRA...
View ArticleTwo new things we love in Confluence
The Atlassian tools and third-party plugins for Confluence are evolving all the time and at RadBee we’re always on the lookout for changes that might help to support your compliance and quality...
View ArticleTraining management with JIRA
Managing a life science company’s training records is notoriously difficult. Wouldn’t it be great if training could become a routine part of the way your team works, and if your training matrix and...
View ArticleCompliance, usability and culture in quality management
The biggest challenge in building a quality management system (QMS) is accommodating the needs of both compliance inspectors and your team. However this is a challenge worth meeting, because only by...
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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...
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Risk analysis in Jira
You can use Jira to manage all elements of the traceability matrix, including the risk analysis itself. If your risks are all closely linked to requirements, this will help your team keep them in mind...
View ArticleRisk analysis for computerised systems
When done correctly, risk analysis can help to identify things that could go wrong in a process once it has been put into action. It may also trigger creative thinking about how to avoid those problems...
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Process mapping
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...
View ArticleRequirement specifications
When teams set out to determine the requirement specifications for a computerised system, confusion often arises. However there are some simple steps you can take that will help you build up a clear...
View ArticleFrom Paper-Based to practical: How we digitised a paper-based QMS & ensured...
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...
View ArticleHow to validate computerised systems used for GxP and Medical devices...
8 February 2018, Stuttgart, Germany (9:00-17:00m)Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany In an age where computerised systems make the difference between winning and...
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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...
View ArticleHow 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...
View ArticleStuttgart Summit: Highlights & takeaways on how to validate software...
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...
View ArticleAgile 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...
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The art of creating complete & accurate records for FDA inspections from Jira
If you need to maintain information for an FDA inspection or submission, Jira is a great tool to use. Be aware, however, that the Code of Federal Regulations Title 21, part 11 requires you to be able...
View ArticleHeading toward hands-free validation
Over the course of working with dozens of innovative, exceptional companies, I’m always struck by their commonalities of purpose and process. While they all are creating products poised to help us all...
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