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.
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
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.
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
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!
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.
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.
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.
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)
Finding what the true cost is of a paper-based quality management system can lead you to some surprising findings if you've stuck with this process for years. You may still think using paper is easier since it's so convenient to write something down in a hurry. Employees may think the same thing, or maybe not. They may just go along with your management concept because they're so used to it.
Amazon Web Services was recently named a leader in the 2015 Public Cloud Storage Services Magic Quadrant report, and it has particular significance to those who depend on cloud technology. Here at ZenQMS, we want to share the report with you for a good reason. We rely on Amazon Web Services as our main infrastructure for our electronic quality management system platform.