Start Now
Start

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. 

Read More

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.  

Read More

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.

Read More

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.

Read More

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. 

Read More

Topics: the business of quality, best practices, QLF

Rethinking IT Investments for Life Sciences Companies

Posted by Celia Brown on Sep 4, 2019, 9:01:00 AM

 ZenQMS recently  hosted a live webinar featuring a presentation by Ed Morris, Managing Partner of The Morris Group and a well-known IT and Compliance expert.  If you missed it, there is a replay available on-line and I've written up a brief summary here:

Read More

Topics: Webinar, biopharmaceutical, best practices

How Using Courses to Maintain your Company’s Training Matrix is Just Like College

Posted by Emily Ruth on Aug 27, 2019, 1:37:00 PM

When you think about it, a department, job function or role within a company can be easily be compared to working towards a degree with a specific major.  At most any University or College, there will be requirements that apply to all enrolled students as well as courses that are required for specific majors. And for each course requirement, there are quizzes, tests, and papers that need to be written to pass that course. 

Read More

Topics: eQMS, best practices, training

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.  

Read More

Topics: Quality Compliance, intelligent quality

Global Distribution with a Quality Focus at Xerimis

Posted by Celia Brown on Aug 13, 2019, 11:34:00 AM

“We’ve been able to reduce on-site audit time by more than 50% because we are able to provide auditors access to review documents in ZenQMS.”

Read More

Topics: CDMO, case study

5 Quick and Easy Ways to Optimize for Success with your eQMS

Posted by Brendan Lawrence on Aug 8, 2019, 1:15:00 PM

After supporting more than a hundred eQMS implementations in my role as head of Operations here at ZenQMS, I have observed that the conversion from a paper-based to electronic quality management system (eQMS) can be either painful and cumbersome or quick and easy. The determining factors seem to be centered on the ‘health’ of the business’ quality processes- especially those related to document management and training.

Read More

Topics: quality leaders, intelligent quality, best practices

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.

Subscribe to Email Updates

Recent Posts