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Read & 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...
View ArticleWhat 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...
View ArticleThe Gist of Writing Better Read And Understood Training Docs
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 &...
View ArticleWhy the Way to a Hellish Quality System May Be Paved With Best Practices
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...
View ArticleHow to Easily Integrate Radbee’s Read & Understood Training Genius With...
If you are using Comala Workflows App to manage your controlled documents, then your “read and understood” rules should be aware of the workflow status of the page. For example, if you would like...
View ArticleGetting started with the Read & Understood Training Genius App for Confluence
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...
View ArticleWhy Confluence is the Perfect System for Read & Understood Training
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...
View ArticleMore Quality, Less Bureaucracy: How QA Managers Can Streamline Read &...
In my work with Life Sciences companies, I’ve found that most companies today use Read & Understood training extensively.In theory, this simplifies initiating new team members and keeping your...
View ArticleIntroducing The Read & Understood Training Genius App For Confluence:...
Created by quality assurance experts and Atlassian Solution Partner, Radbee, the app’s hands-free assignment supports improved productivity.LONDON, United Kingdom, April 3, 2019: Life Sciences...
View ArticleWhy waste reduction is the #1 priority for QA & Compliance, according to experts
At a recent knowledge sharing and networking event in London, England, life science industry professionals gathered to glean insights from experts on the common challenges experienced in implementing...
View ArticleSurvey says: Proactive quality risk management for life science companies is...
Klavs Esbjerg, CEO and founder of Epista Life Science, is on a mission to help his clients continuously improve regulatory compliance and in turn, transform their compliance obstacles into real...
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Why digitised design control is essential for the sustainability of your DHF
Thanks to Laurence Sampson for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London, 3/10/2018) In today’s competitive...
View ArticleThe difference between data integrity & data quality in medical technology...
Thanks to Keith Williams for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London, 3/10/2018) Data is the lifeblood of any...
View ArticleHow paperless validation makes a world of difference to pharma success
For many of the medtech and pharmaceutical companies I consult with, there’s a common clash of the validation systems “worlds” raging: traditional, “this is how we’ve always done it” paper...
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Sick of repeating yourself? Try engineering your procedures in Confluence
Confluence is much more than a Wiki. As you become a power user of Confluence, there are many macros that can help simplify the process of writing better documents. Take for example, the Comala...
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Agile for GXP and Medtech
These are exciting times to serve the life sciences sector – thanks to technological advances, innovations abound and progress marches on at a lightening-fast clip. Working with a wide variety of...
View Article4 Smart lessons quality managers can squeeze out of a juice bar
If you’ve ever wandered into a popular juice bar and decided to consume your favorite pressed beverage on-site, you may have noticed a few interesting aspects of the shop’s management that resonate...
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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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 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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