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ZenQMS Blog

Panos Boudouvas

Panos started ZenQMS to provide quality professionals better eQMS tools for enhanced compliance at an affordable price. Panos previously served in multiple executive roles at Aptuit, a leading Pharma CRO/CMO. Most recently he was a member of the Executive Committee and Vice President of Operational Excellence responsible for the worldwide launch and management of Aptuit’s LeanSixSigma program as a certified LeanSixSigma Black Belt. Mr. Boudouvas was one of the first employees at Aptuit, leading the corporate development effort through a broad acquisition program. Mr. Boudouvas also served served as Director of Facilities & Capital Development, which included global responsibility for 16 facilities, more than 100 full-time staff members, a ~$50 million annual operating budget and several multi-million dollar facility expansion and maintenance projects. Prior to Aptuit, Mr. Boudouvas served multiple roles in Private Equity and Investment Banking firms, with a focus on the pharmaceutical, healthcare services and technology industries. Panos is an Edward Tuck Scholar from The Tuck School of Business at Dartmouth and holds a BS in Commerce from the McIntire School at the University of Virginia, where he graduated with Distinction
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Recent Posts

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

COVID 19 Statement

Posted by Panos Boudouvas on Mar 17, 2020 8:00:21 AM

A message to our community of customers and partners:

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Topics: risk, Corporate News, Business Continuity

2020: The Year of Intelligent Quality

Posted by Panos Boudouvas on Jan 15, 2020 10:26:58 AM

Intelligent Quality is an approach that is rooted in the digital transformation that we’ve seen across all lines of business over the past decade or so. The complex, modern organization has tools available in their ‘back office’ that offer data analytics and valuable insights to company leaders- enabling them to make informed decisions about their business strategy. We have seen the explosion of growth and advancement in CRM and ERP, for example, and there is no reason for quality and compliance teams to continue to use stone- age tools.  

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Topics: quality leaders, intelligent 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

5 Signs that it is Time to Invest in an eQMS

Posted by Panos Boudouvas on Nov 7, 2019 12:47:32 PM

I often speak to quality leaders and other executives who boast that their paper-based quality management system is “perfectly sufficient” to meet the needs of their business. I just nod and smile because I anticipate that I will be hearing from them (in a panicked state) in the very near future when they realize the limitations of a manual QMS.  

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Topics: eQMS, intelligent quality

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

Announcing the Life Sciences Quality Leaders Forum

Posted by Panos Boudouvas on Aug 20, 2019 4:25:32 PM

QFL-brought-to-you-by-ZenQMSI am frequently in meetings with quality leaders and regulatory experts where I find myself wishing I could share some part of the conversation or findings with a broader audience.  Something about the current state of affairs, best practice or just a really eloquent description of a pain point and how they are managing.  

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Topics: Quality & Compliance, intelligent quality

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

7 Percent of your documents are missing - Really.

Posted by Panos Boudouvas on Jan 19, 2016 12:13:22 PM

The true cost of paper-based quality management systems is quite varied when you consider that using paper creates a vast ripple effect on companies. It extends all the way from how papers get filed to how a manager communicates with employees. What's problematic is some of these costs are possibly invisible until you fully understand the duties of your document manager.

That's why it's important to always analyze your company and processes if you've used paper documents for years. You may discover certain procedures your managers and other employees use out of habit cost you more money and time than you realized.

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Topics: Cloud / SaaS, eQMS, Manual QMS

The True Cost of Paper-Based Quality Management Systems in Equipment and Procedures

Posted by Panos Boudouvas on Dec 14, 2015 4:56:15 PM

Finding what the true cost is of a paper-based quality management system can lead you to some surprising findings if you've stuck with this process for years. You may still think using paper is easier since it's so convenient to write something down in a hurry. Employees may think the same thing, or maybe not. They may just go along with your management concept because they're so used to it.

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Topics: Blogs, Cloud / SaaS, Manual QMS

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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