ZenQMS Blog

GMP Training - Are You Watching it as Closely as the FDA? Ways to Bring Compliance

Posted by Jeff Thomas on Apr 19, 2016 2:04:56 PM

GMP training remains a necessity in the pharmaceutical industry to keep products in line with FDA compliance. However, many employees who have to hear about Good Manufacturing Practices have little enthusiasm for it, especially because it has to occur at least once a year. The reasoning behind this low opinion comes from recent emerging incidents.

About six years ago, concerns developed about how bad GMP training had become in many pharma industries. The FDA even sent out a warning

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Topics: Cloud / SaaS, eQMS

The Training Matrix: An Essential Tool

Posted by Jeff Thomas on Apr 14, 2016 7:00:00 AM

The Training Matrix: A Simple Tool

Tracking the training of employees has the highest priority in life sciences organizations that are under regulation of the Food and Drug Administration (FDA). The training matrix is simply a table that lists the skills (documented by training) and completion status for each employee or team member. When the number of standard operating procedures (SOPs) for which employees must be trained gets large, the matrix can get very difficult to maintain by hand. Yet, if procedure violations cause product recalls or other sanctions by the FDA, "inadequate training of personnel" is often the specific cause. Lack of training in particular required SOPs is the secondary cause of many costly failure during inspections. 

Trouble with your Training Matrix?

The complexity of the spreadsheet-based training matrix makes it difficult and costly to maintain it by hand. Keeping the training of each employee up to date in each of the relevant SOPs in life-sciences-based production almost begs for errors. It is one of the most important quality control issues.

Every year, the FDA issues "plenty of 483s and warning letters." Many of them center on the failure to have or to properly utilize their SOPs. The responsibility, as far as the FDA is concerned, is to make sure

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Topics: Blogs, ZenQMS, Cloud / SaaS

Do you know the cost of your paper QMS?

Posted by Jeff Thomas on Apr 12, 2016 10:24:49 AM

We've just published a new tool to let you estimate the cost of your paper Quality Management System. It only takes a few seconds to complete - Try it out!

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Topics: eQMS, Paper

Does your training matrix exceed 100,000 entries too?

Posted by Jeff Thomas on Apr 7, 2016 2:11:42 PM

According to the Journal of Pharmacy, the average pharmaceutical company has 1250 Standard Operating Procedures (SOPs) and over 150 employees. This makes a typical Excel training matrix responsible for at least 187,500 combinations of training (1250 x 150). These combinations do not account for tracking revisions of SOPs, managing relationships between different offices, or integrating research and development with SOP updates. 

Maintaining a non-validated Training matrix at even a fraction of that size is a prime area to fail an audit or fall out of compliance. Good Quality Management Systems (QMS) reduce the time

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Topics: Quality Compliance, ZenQMS, Paper

How Costly Is Your Quality Management System? Is It Time to Be the Monday Morning Quarterback?

Posted by Jeff Thomas on Mar 15, 2016 2:42:07 PM


Perhaps the biggest challenge facing a quality management team today, especially in the Life Sciences, is how to comply with regulations and take advantage of new cost-saving opportunities when the regulatory environment is fluid.

Maybe it’s time to do some Monday morning quarterbacking to see how your quality management system can grab every opportunity to regain possession of the ball. You may find that the true cost of your paper-based quality management system is ready for a game-changer.

Pivoting to comply or capture a new opportunity

In a recent “Monday Morning Regulatory Review,” the Federal Regulations Advisor reports that “the United States Court of Appeals for the Second Circuit held that the Department of Health and Human Services (HHS) 2000 regulation barring certain hospital reclassifications violated the plain terms of the Medicare Act and, therefore, was invalid….” As a result, HHS is now under some pressure to review its reclassification system for the purpose of reimbursement under the Medicare Act.

Consider the steps you have to take now, with your company’s current paper-based quality management system, to comply with a new regulation.

  • Depending on the extent to which a new regulation alters the field, pivoting may require your calling a great number of “time-outs” from the routine workflow to comply or to take advantage of a new opportunity.
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Topics: Quality Compliance, ZenQMS, eQMS

A picture is worth a 1000 words (or 10 pieces of paper)

Posted by Jeff Thomas on Feb 22, 2016 9:39:37 AM

The true costs of paper based Quality Management Systems are shocking. Investing 6 figures and 12 months to fix that problem can be shocking too. ZenQMS can solve your run-away costs faster than you realize and with an Instant Return on Investment. Take a look at this infographic which outlines many of the costs of a paper based Quality Management System

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Topics: Blogs, eQMS, Paper

4 Trillion Documents and Counting...

Posted by Jeff Thomas on Feb 11, 2016 12:18:27 PM

Are you still using paper and spreadsheets to record and track critical information about your business? You're not alone! Document management experts estimate that 90% of corporate data resides on paper or in an unstructured format!

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Topics: ZenQMS, Cloud / SaaS, Paper

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, Paper

Who beat Amazon Web Services this time?

Posted by Jeff Thomas on Jan 15, 2016 6:51:14 AM

We're proud of our deep ties with Amazon, and once again, they are at the top of the ratings.

In the 2015 Critical Capabilities for Public Cloud Infrastructure as a Service, Worldwide report, Gartner scored Amazon Web Services highest in all four use cases: Application Development (4.81), Batch Computing (4.81), Cloud-Native Applications (4.84), and General Business Applications (4.53). AWS has a long history of serving customers of all sizes with the industry’s broadest and deepest platform and the fastest pace of innovation to bring new value to the cloud.

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Topics: ZenQMS, Cloud / SaaS

Is your QMS at risk if it is NOT in the Cloud?

Posted by Giulia Umile on Jan 13, 2016 1:40:40 PM

While there has been some debate about the security of data stored in the cloud, the reality is that there is a great deal of emphasis put on ensuring security with cloud applications.

The real question that you should be asking is, "Is your QMS at risk if it is not in the cloud?" The answer to that question is, "Absolutely." Why can that be said?

Paper-Based Systems and Business Continuity Planning

Organizations that use on-premise, paper, and spreadsheet-based quality management systems face a challenge when designing a viable business continuity plan.

An essential part of a comprehensive risk management strategy, a solid business continuity plan is designed to protect the assets and processes of a business in the event of a crisis or disaster.

Ignoring the necessity of a business continuity plan puts a company at considerable risk. At the least, a disruption in business processes caused by a disaster event may cause you to lose clients. At the worst, it could spell the end of your business entirely.

According to FEMA estimates, 40 percent of businesses do not reopen following a disaster. On top of that, another 25 percent fail within one year. These statistics underscore the seriousness of failing to adequately plan to protect your business in the case of disaster.

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Topics: Security, Cloud / SaaS, eQMS

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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