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The red tape challenge
It has almost become routine: under narratives of increased patient safety and improved efficiency new regulatory requirements are developed, resulting in increased requirements on the industry. The...
View ArticlePainless migration from Excel
One of the most common concerns with the implementation of new operational software is the effort involved in migrating the existing data to the new system. I just recently had an opportunity to show...
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Why should Quality Assurance be difficult and awkward? Take a strategic view...
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making...
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Get Everybody Engaged with QA
Quality Assurance is not a one person or one team business. In exactly the same way that budget control is not only the CFO’s business, keeping a whole organization in compliance cannot be achieved by...
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Process Validation & Verification for All
Recently I was invited to give a Process V&V presentation at the Medtec UK conference in London. My challenge was to create a presentation which is accessible to an audience with very different...
View ArticleThe red tape challenge
It has almost become routine: under narratives of increased patient safety and improved efficiency new regulatory requirements are developed, resulting in increased requirements on the industry. The...
View ArticleWhy should quality assurance be difficult and awkward? Take a strategic view...
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making...
View ArticleClik here to view.
Painless migration from Excel
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View ArticleProcess validation and verification for all
Recently I was invited to give a Process V&V presentation at the Medtec UK conference in London. My challenge was to create a presentation which is accessible to an audience with very different...
View ArticleGet everybody engaged with QA
Quality Assurance is not a one person or one team business. In exactly the same way that budget control is not only the CFO’s business, keeping a whole organization in compliance cannot be achieved by...
View ArticleWhy move your SOPs to a wiki?
wiki /ˈwɪki/ noun A website or database developed collaboratively by a community of users, allowing any user to add and edit content. source: Oxford Dictionaries Incorporating a wiki into your intranet...
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JIRA plugins for quality management
While JIRA is already a great platform for issue tracking and business process management, we find that boosting it with plugins makes it much more useful for quality management purposes. Here we list...
View ArticleControlled documents: versioning in Confluence
Confluence comes with built-in document version management. Each time a document is modified then saved, a new version is added to the history and automatically tagged with a version number, starting...
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Using Comala Workflows for approval of controlled documents
When considering using Confluence to develop and release controlled documents, one of the main concerns many companies have is whether they will be able to approve the documents directly from the...
View ArticleRadBee recognized as a JIRA and Confluence Expert
Cambridge, UK, 12 October 2015: RadBee Ltd, which specializes in providing software solutions for quality assurance in the medtech, biotech and pharmaceutical industries, has been approved as an...
View Article10 good reasons to use JIRA for your quality assurance processes
In the beginning there was the SOP. Then a form was created to collect all the necessary data and signatures to prove that the SOP was followed. Then people forgot why the process was developed in the...
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Managing your CAPAs in JIRA: key questions answered
Outside the software development sphere, for which JIRA was originally developed, probably the most frequent quality management process facilitated by JIRA is the corrective and preventive action...
View ArticleWhy JIRA Service Desk can turn you into a hero
Life sciences quality management procedures are often awkward. Dotted with their own strange lingo (observation, device master record (DMR), technical file, essential requirement etc), they can take...
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How triaging customer issues can help you streamline CAPA management
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...
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Why the controlled document lifecycle matters
Often, when life sciences companies are working to define their controlled document management process, they spend a lot of time considering the regulations and ensuring that their approval process and...
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