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ZenQMS Blog

Quality Leaders Forum Raleigh Durham: What are your Greatest Risks in Systems Validation?

Posted by Panos Boudouvas on Nov 12, 2019 11:26:08 AM

John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing  over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder.  That was just one of many times that he observed teams not taking a risk-based approach to systems validation. 

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Topics: the business of quality, QLF

What’s in a Quality Rating? Probably not enough (yet)

Posted by Panos Boudouvas on Oct 31, 2019 9:15:47 AM

Janet Woodcock made headlines (again) by discussing the possibility of a quality rating system to aid transparency in her recent blog. But the devil is in the details when it comes to ratings for a site’s quality maturity.

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Topics: intelligent quality, the business of quality, News

Think A Quality Culture Doesn't Affect Your Bottom Line? Think Again

Posted by Judy Carmody on Oct 1, 2019 11:06:00 AM

Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.

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Topics: quality leaders, the business of quality

Boston Quality Leaders Forum: Scaling Your QMS for Business Growth

Posted by Celia Brown on Sep 25, 2019 9:55:19 AM

The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future. 

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Topics: the business of quality, best practices, QLF

To Efficiency and Beyond: Demonstrating the ROI of your eQMS

Posted by Panos Boudouvas on Jul 3, 2019 2:53:47 PM

Today's savvy quality leaders know that securing executive support and buy-in are key factors  in successfully selecting and implementing an enterprise quality management system. Convincing skeptical C-suite colleagues of the strategic implications and costs of  the current state can be challenging, especially in documenting both hard costs and intangible benefits/risks.   It is necessary to speak in terms that they understand and appreciate, starting with Return on Investment (ROI). 

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Topics: eQMS, quality leaders, the business of quality

ZenQMS offers  a validated Quality Management System (QMS) with fast implementation and full features. Whether you are trying to improve your paper based QMS or build a new electronic Quality Management System, ZenQMS can help you implement an affordable QMS in less time and for less money that you might think.

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