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ZenQMS Blog

Current Climate only emphasizes the need for efficient eQMS

Posted by Panos Boudouvas on Apr 7, 2020 3:48:14 PM

Amidst this turbulent moment in our lives, with a global pandemic threatening us and our loved ones directly, and the specter of the coming economic recession already making waves, it is important to acknowledge that the hard work of life sciences development and manufacturing continues.  And while global regulatory requirements remain in place, many companies will be forced to stretch budgets further and possibly with fewer FTEs (due to cuts). And in a new complication-- teams will have to truly do more (or everything!) remotely-- manage policies and related training compliance, investigate deviations, manage change controls, host/conduct audits, sign/review documents, etc.  

For those relying on manual systems,  these conditions only exacerbate the problems you already know about in terms of scalability and inefficiency.  Some teams were already down the path in acquiring a platform only to find new concerns voiced about large price tags from your executive colleagues and boards. 

So now more than ever we reiterate two key points:

  1. An eQMS platform can really help you operate more efficiently and in a more compliant way (see the articles below):
  2. Acquiring and implementing an eQMS just doesn’t have to break the bank. Really.  

Give us a call, and let us help you spend more of your capital towards what really matters-- developing to your next clinical milestones or delivering for your clients.  

 
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Topics: eQMS, the business of quality

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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