ZenQMS Blog

How Many Combinations Does It Take For Your Training Matrix To Fail?

Posted by Jeff Thomas on May 31, 2016 11:00:00 AM

At what point does an Excel spreadsheet management system begin to fail for your training program? 

Variety in Data

The more data you include in a training program, the more information your management team has to track in Excel. Once a program gets more than two parameters, additional data becomes increasingly difficult for a manual spreadsheet to manage. 

Even if the number of variables is only of two types, as the numbers of those increase, the information becomes unwieldy and difficult to manage. A small organization training 5 staff on a limited number of SOPs (200) will still have over 1000 entries to manage. Manual data management becomes difficult to do, and even with limited functionality in Excel, a robust training and data management system will overwhelm any spreadsheet used.

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Topics: ZenQMS, Paper

GMP Training - Are you watching it as closely as FDA is?

Posted by Jeff Thomas on May 3, 2016 2:15:13 PM

Pharmaceutical firms cannot have any errors in the manufacturing process.  One process or supply error can contaminate an entire production cycle. At the same time, the government has strict standards on the manufacturing process that must be followed.  Violating these can result in fines or production halts. To avoid these issues, companies create Good Manufacturing Practices (GMP) and put in place stringent training. GMP training is important to the FDA and helps the company achieve a high level of performance and quality.

In fact, companies must be aware of stepped up actions by the FDA to protect consumers. The FDA questions the training and production of chemical products by employees at every step in the process. For example, the FDA recently warned a cosmetics company because a single chemist in its R&D facility did not have the necessary training on microbial limits to prevent critical errors. The FDA continues to issue more

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Topics: ZenQMS, eQMS

7 Signs You Are Having Trouble with Your Training Matrix

Posted by Jeff Thomas on Apr 26, 2016 10:00:00 AM

Trouble with your Training Matrix?

Pharmaceutical companies use large training matrices to track employee's proficiency on SOPs, manufacturing processes, quality controls, and product reviews. When these training matrices are out of order, inefficient for employees, and do not deliver the right information to management, they cause multiple problems.

These seven problems are symptoms that your company's system needs to be updated and upgraded in order to maintain high quality product delivery. How many of these signs is your organization suffering from?

1. Human Entry Errors

Trouble with a training matrix occurs when people enter information regarding SOP training, or in the entry of other information they should have been trained on. Statistically predictable variations in quality information are almost always a result of management systems.

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Topics: Quality Compliance, ZenQMS, 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

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

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

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

Did you miss it? Data center qualification webinar now available anytime at ZenQMS

Posted by Jeff Thomas on Dec 21, 2015 3:07:36 PM

Last Wednesday, Ed Morris, from the Morris Group delivered an engaging webinar around a topic that is near and dear to many of us in regulated industries. Ed presented, "Is data center qualification still relevant?" to a group of customers and industry experts. In his informative and detailed presentation Ed dealt with these critical topics in a world that continues to march towards Cloud, SaaS and hosting. Some highlights included:

  • GAMP V vs Reality
  • What is a qualified Cloud environment
  • GMP, ISO, IEEE and CFR Requirements
  • What is a high risk data center?

Even if you missed it, you can view the webinar (or download the slides below)

Download the Presentation

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Topics: Webinar, ZenQMS, Security, Cloud / SaaS

Is data center qualification still relevant? Join us for a Webinar on December 16th to address this question.

Posted by Jeff Thomas on Dec 8, 2015 3:00:02 PM

As the cloud continues to dominate the software landscape and become more critical in regulated environments, questions arise over data center validation. Join us on Wednesday December 16th at 1:00pm Eastern as we join Ed Morris of The Morris Group to discuss what data center validation means in the age of cloud-based offerings and virtual server infrastrustures.

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Topics: Blogs, ZenQMS, Security, Cloud / SaaS

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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