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ZenQMS Blog

What is the relationship between data integrity and quality culture?

Posted by Celia Brown on Feb 24, 2020 1:08:00 PM

Data integrity is at the heart of quality culture and everything we do in the life sciences industry. It is a term that is often used synonymously with regulatory compliance but they are not actually the same at all.  Whether or not you are building- or intending to build- commercial products, the data you are generating will later inform commercial filings and applications that will add value for the business. And so that data- and the ability to defend that data all the way back to the source- is very important. 

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Topics: QLF, quality culture, video, data

10 Tips for Audit Preparation for Emerging Life Sciences Companies

Posted by Celia Brown on Feb 20, 2020 2:33:48 PM

Whether it’s your first or fifth or five hundredth audit, you can never be too prepared. We recently hosted a webinar on exactly this topic, hosted by quality and systems expert Ed Morris. Morris walked through tips for preparation for and day of your audit.  

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Topics: Webinar, best practices, quality culture

Tips for Selecting an eQMS

Posted by Celia Brown on Feb 19, 2020 9:45:00 AM

Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. As Director of Quality, he led eQMS implementations from the ground up. Given Mr. Banerjee's deep experience in selecting and implementing eQMS solutions in the life sciences industry, we asked him to share some tips for those who are just getting started or in the midst of their purchasing decision. 

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Topics: eQMS, QLF, video

ISO in the Cloud

Posted by Celia Brown on Feb 17, 2020 12:47:00 PM

bill-oxford-tR0PPLuN6Pw-unsplashRegulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies. 

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Topics: Quality & Compliance, ISO

The Role of an eQMS in a Quality Culture

Posted by Celia Brown on Feb 13, 2020 9:30:00 AM

 

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Topics: intelligent quality, quality culture, video

An ISO Primer for Life Sciences Quality & Regulatory Leaders

Posted by Karin Ashkenazi on Feb 10, 2020 8:09:00 AM

Why pursue ISO? 

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Topics: Quality & Compliance, ISO

IronShore Pharmaceuticals Prepared for Commercialization with ZenQMS

Posted by Celia Brown on Feb 6, 2020 10:39:43 AM

About Ironshore

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Topics: biopharmaceutical, case study

eQMS—The Key to Success or Failure

Posted by Sourav (Neil) Banerjee on Feb 4, 2020 9:30:00 AM

An electronic Quality Management System (eQMS) is the key in today’s world for preventing quality issues that can have life or death consequences for patients. Companies with tremendous potential in the regulated pharmaceutical industry can fail badly if they do not implement the right eQMS. Yet organizations that easily implement automated systems for many other functions often do not have an adequate eQMS in place. This is usually because the need for an eQMS is not understood early enough.

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Topics: eQMS, QLF

Life Sciences Quality Leaders Forum Princeton: Audit Preparedness

Posted by Celia Brown on Jan 27, 2020 10:10:00 AM

Members of the Life Sciences Quality Leaders Forums met in Princeton, New Jersey to discuss the ins and outs of audit preparedness in the midst of an ever-changing regulatory environment. Ed Morris, President and CEO of The Morris Group, shared his expertise with the group, suggesting that the first step should be to thoroughly evaluate your organization’s Quality Management System (QMS) and identify any gaps.  

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Topics: best practices, QLF, audits

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

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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