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.
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.
"Thanks to ZenQMS, my team is now able to quickly and accurately respond to audit inquiries and the error rate is significantly lower than with our prior quality management system.”
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.
Over the course of the past twenty years, I have steadily reduced my reliance on paper items, eliminating checks, airline tickets, maps, personal calendars, pay stubs and files, freeing me to function with only a laptop and smart phone. And yet, many of the Quality Departments I work with, from various high-tech industries throughout the world, have not yet embraced new technologies. They still rely on inefficient manual paper systems to monitor the performance of their process. Why the avoidance of modernity?
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).
Pressures are increasingly mounting for life science companies from multiple directions- customers, internal business stakeholders, and regulators. Quality leaders need to keep up with the latest regulatory updates in the life sciences industry and simultaneously scale and automate internal compliance and document control processes.
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