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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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How paperless validation makes a world of difference to pharma success

How 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 documentation versus newer, tech-driven solutions. In order to effectively harmonize business processes company-wide, I argue that innovation is critical, as the challenge is not just to validate a system for now, but also to keep it validated far into the future. This kind of planetary shift in corporate culture doesn’t happen overnight. The resistance that stems from legitimate concerns like compliance...

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Sick of repeating yourself? Try engineering your procedures in Confluence

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 metadata plugin (free plugin for Confluence server). By providing a set of macros that allows you to easily define your metadata, and then refer to it, Comala has long been a vital part of any Confluence (server) installation. The following two examples illustrate how metadata can make your quality process documents both easier to write and maintain. Use Case #1: Define Metadata once & use it...

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Agile for GXP and Medtech

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 organisations, I see two very different types of teams searching for an answer to the same fundamental question: "How do I best do Agile and still comply with regulations?" (For example, ISO-13485, GAMP® 5, etc.) On one side there are traditional pharmaceutical companies. These companies have established ways to create software and have the manpower, capacity, knowledge and procedures to manage...

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4 Smart lessons quality managers can squeeze out of a juice bar

4 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 with your role as a quality manager: Juice bars are focused on health, as they provide drinks, smoothies and snacks that are full of vitamins, antioxidants and other vital nutrients. The best juice bar managers aren't there solely to collect a paycheck; they are also focused on supporting the wellbeing of the people they serve. Like a juice bar manager, you also seek to improve the health and...

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    One of the “free wins” that quality managers get when they put their QA processes in Jira is the opportunity to use Kanban boards. This agile project management tool helps teams visualize work and improve efficiencies. Where quality processes tend to be obscure with their dedicated lingo and long-winded SOPs, Kanban boards provide clarity to […]

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    How Agile Teams Can Avoid Being Victims of Their Post-it Habits

    As an eQMS specialist who frequently works with agile teams, I often walk away from meetings thinking, “Boy, do I wish I owned stock in 3M, the original makers of post-it notes!” While post-its are famously used for design sprints, their versatility makes them a naturally powerful brainstorming tool for agile teams. It was at […]

  • The Gist of Writing Better Read And Understood Training Docs, Part 2
    The Gist of Writing Better Read And Understood Training Docs, Part 2

    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 reason that you can’t achieve both goals by making it quick and easy for trainees and auditors alike to […]

  • What does eQMS success looks like?
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    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 not the point of evolving your quality system. Just like smart phones weren’t only an upgrade of the dial telephone and commercial flights […]