ZenQMS Blog

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.  

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. 

ZenQMS, the leading provider of cloud-based quality management solutions for businesses that desire a simpler path to intelligent compliance, today announced its Summer 2019 release. This release reinforces ZenQMS’s mission to meet customers where they are in terms of QMS maturity and deliver all of the benefits of enterprise-grade software in a flexible, approachable platform. 

A new employee starts on your team. An SOP is updated. A new training video needs to be rolled out company-wide.  You’ll need to update your training matrix and training folders for every one of your employees. Every.Single.Time. 

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). 

Spreadsheets are Error Prone and Pose Problems for Companies in the Life Sciences Industry Today

GMP Training - Are You Watching it as Closely as the FDA Requires?

Reasons for a Heightened Focus on Training and Quality Control  

Training programs are under the FDA’s microscope because insufficient employee training has been identified as a root cause of defects. Additionally, the changing composition of the manufacturing workforce has resulted in an overall lower level of experience among production employees. As layoffs continue to occur and seasoned employees approach retirement age, the following changes have resulted:  

• A loss of experienced employees
• A growing percentage of contract workers
• An influx of new hires with little work experience

It is not easy for companies to compensate for this loss of manufacturing expertise, especially as companies feel pressured to reduce spending across the board. Bolstering training and educationprograms therefore becomes a necessity for companies seeking to maintain quality production.  

How to Strengthen Your Company’s Training and Educational Initiatives  

With the FDA’s increased focus on employee training, it is imperative that companies devote attention to improving their employee

Trouble with your Training Matrix?

Most companies face trouble with their training matrix because employees are unable to track the individual SOPs they need to follow, management is unable to interactively train employees, and the entire system tends to get lost in the mix. This is often caused because Excel or limited database-managed systems have over 100,000 entries. These entries are difficult to search and track and cost users time and energy just to guarantee that they have fulfilled training

An increasingly critical part of GMP training is to ensure that every company employee has received sufficient education and training regarding key processes in the manufacturing of a product. Companies must also provide detailed documentation regarding the scope of training programs and dates of completion for training modules. Failure to provide detailed evidence of employee training programs may result in warning letters or sanctions by the FDA.  

The FDA's Increased Focus on Training Programs

In recent years, the FDA has devoted increased attention to the review of training records and quality control procedures. With manufacturing problems frequently being linked to improperly trained personnel, the FDA has identified training as an area that requires sustained focus. Training programs have become increasingly important over the past decade as companies lose seasoned employees due to retirement or layoffs. When a company is staffed primarily by contract workers and new hires, effective training becomes critical because a smaller percentage of employees have a long working historywith pharmaceutical products. Companies that have reduced their training budgets or plan to do so in the near future should proceed with caution. 

Measures to Improve Your Company’s Employee Training Program  

In the world of FDA investigations, a verbal acknowledgement of the existence of an employee training program is not sufficient. FDA