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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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Heading toward hands-free validation

Heading 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 live happier, healthier and more productive lives, ironically enough many tend to put themselves through sadly torturous, inefficient circumstances before their products can see the light of day. And more often then not, the validation cycle is the place where all hell breaks loose. Case in point: One of the biggest and most innovative pharma companies in the world hired us to set up a Jira...

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The art of creating complete & accurate records for FDA inspections from Jira

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 to export that data from the system into a readable, precise document: 11.10. (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the...

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Agile and design controls: From story to specifications

Agile 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 to strike the balance, you must understand the difference between "stories" (Agile term) and "specifications" (Design Controls term). From my experience working with many teams that are "Agile first," I have seen firsthand how easy it is for people to believe that Agile stories are the same as specifications. Not only are they not the same, but also the difference is critical to how you work...

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