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Why the Way to a Hellish Quality System May Be Paved With Best Practices

Why 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 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 the job done is strong. Thus “best practices” can actually become a euphemism for cutting corners and taking an apparently easier way out. True best practices are bespoke — they have to be written to suit your...

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How to Easily Integrate Radbee’s Read & Understood Training Genius With Comala Apps

How to Easily Integrate Radbee’s Read & Understood Training Genius With Comala Apps

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 people to train on pages that have a new official version, which is about to or has recently gone into effect, you’ll want users to be notified. On the other hand, if your updates are still in the process of being authored, reviewed and/or approved, you want to be sure the system stays mum until it’s official. The easiest way to achieve this depends on whether you are also using Comala Publishing or...

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Getting started with the Read & Understood Training Genius App for Confluence

Getting 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 QA managers with greater control and time-saving automation -- all that needs to be done is to set the training matrix rules and the app takes it from there. What is a training matrix? The training matrix is comprised of three components: Users who need to be trained. This could be individuals, a department, or everyone in the company. Pages that these users need to train on, such as a quality...

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Why Confluence is the Perfect System for Read & Understood Training

Why 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 a healthy bottom line. Externally, the outside world benefits from safer, more accurate software and tools for user/patient wellbeing. Implementing a streamlined, intuitive, compliant training program can, however, be its own beast. For many companies, particularly at the enterprise level, training can be a complex, slow-moving process whose administration alone may eat up all of a QA manager’s...

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More Quality, Less Bureaucracy: How QA Managers Can  Streamline Read & Understood Training in Confluence

More Quality, Less Bureaucracy: How QA Managers Can Streamline Read & Understood Training in Confluence

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 existing staff up-to-date. No quizzes or tests to create; all QA managers have to do is publish a document and send it to those who need that information to get their job done right. In practice, though, there are a lot more inefficiencies and waste than meets the eye. I found this out firsthand when I was asked by a large company to implement a systematic, hands-free Read & Understood system....

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Introducing The Read & Understood Training Genius App For Confluence: Compliance For Life Sciences Companies Worldwide Has Never Been Easier

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 companies extensively use Read & Understood training to simplify compliance, yet the process is complicated by the burden of administration on Quality Assurance (QA) managers. Inspired by their work developing custom, automated, compliant training solutions for enterprises, Radbee has now made it possible for all life sciences companies to access a robust turnkey solution with their new Read &...

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Why waste reduction is the #1 priority for QA & Compliance, according to experts

Why 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 effective quality systems. While there were many important points made, the one consistent takeaway was that the key to practical QA and compliance is the reduction of waste. This ultimate truth was expressed in a variety of ways across the various presentation. The following offers a snapshot of how a broad range of businesses and consultants see the importance waste reduction in the life...

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Survey says: Proactive quality risk management for life science companies is a must

Survey says: Proactive quality risk management for life science companies is a must

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 business opportunities. The practical aspects of this vision are as important to regulatory bodies as they are to the companies Epista serves. To get clear on the real challenges facing the Life Science industry, in 2017 Epista pioneered a novel methodology that actually measures compliance in pharmaceutical, medical devices and biotech companies. Here’s snapshot of sample and the survey: 35 sets of...

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Why digitised design control is essential for the sustainability of your DHF

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 landscape, every stage of the regulatory process - from first submission through ongoing, annual or semi-annual iterations - is a make-it- or break-it-scenario. From delays to audit failures and recalls, the challenges that may derail your product releases and updates are significant. Digitized design control is the key to staying on track for a smooth launch and ongoing evolution of your device....

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The difference between data integrity & data quality in medical technology companies – and why you must care

The difference between data integrity & data quality in medical technology companies – and why you must care

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 Life Sciences company - and trust is the heart. For those of us that manage data, we cannot and will not allow drugs or medtech devices to be on the market unless we are certain about the integrity of the data that's been associated with the research, development and production of those products. This is, quite literally, a matter of life and death. The shift in the management and storage of...

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