By Jeff Thomas on May 24, 2016

Pharmaceutical firms are burdened with more and more regulations to remain in compliance. Today, management teams and compliance departments have an amazing amount of SOPs that they must keep track of and monitor.  In fact, for the average firm the training matrix significantly exceeds 100,000 combinations.  With such an enormous volume of data, no single individual can keep track of all of it. For that reason, more companies are implementing cloud-based Quality Management Systems with an eye for improving the training matrix. 

Over the last few decades, companies have been using excel sheets or crude list applications to monitor their SOP compliance. However, a few problems began to emerge with this method. Firstly, unrelenting regulations by the FDA and guidelines by industry associations have exploded the number of SOPs. At the same time, industry consolidation has led to companies getting bigger.  The average pharmaceutical firm is actually 150 people now and the average number of SOPs is 1,250. Multiply those together and you get 187,500 cells in your training matrix.

Excel simply is not made for this many matrix combinations.It becomes slow and unwieldy. Data sometimes does not 

By Jeff Thomas
on April 14, 2016

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

By Jeff Thomas
on January 11, 2016

In order to gain a competitive edge, businesses often find themselves in a position where they're asked to make decisions that are rewarded with some sort of short-term gain at the cost of the quality of their product or service. Yes, a competitive business climate demands that participants be flexible and fluid, but as it turns out, compromising on quality has lasting negative effects that have the potential to sink your business. 

What is the cost of poor quality? You can't begin to value things like solid business planning and methods until you've begun to properly measure and understand the ways that settling on poor quality can hurt your business. How can you do this? The answer is complicated. If you own a restaurant, and insist on purchasing cheap, low-quality food and paying your staff next to nothing, then you'll find that it'll be difficult to attract business and keep your restaurant staffed. Investing in the products/services you provide and the people you work with is smart business, because it's a decision you're making with the future in mind. 

Cutting corners and compromising on quality are choices you can make now that'll help you in the short term, but you'll regret it later. Customers forget good experiences and will remain loyal, but they'll never forget bad experiences. Displeased customers can and will bring their complaints to public internet forums. One bad Yelp review too many can cost you lots of money.

A recent article in Entrepreneur Magazine claims, "On average, a one-star increase on Yelp leads to a 5 to 9 percent increase in a business's revenue, according to an infographic provided by Chatterbox, a company that builds customer-engagement platforms for marketing purposes. On the flip side, one negative review can cost you 30 customers." 

Opting for poor quality doesn't just hurt people in the service industry, but also businesses that provide products. One bad product experience has the potential to drive customers and clients away for years. From a customer's perspective, if they've made the choice to purchase a product from you, they're planning on that product to be good. If the product they purchase is of low quality, they'll go out of their way to not do business with you again.

The same goes for vendors and other business owners. If a vendor has made the decision to purchase goods from you, they're planning on those goods being able to meet the needs of their customers. There's nothing that'll drive business away faster than letting down vendors and customers just because you wanted to save some time or money in the short term. 

Here are some sensible ways you can earn and keep business and make sure you're not cutting corners:

  • Create a Dialogue With Your Customers and Employees: It's vital that you continually check in with your customers and employees. For your customers, ask questions like, "Are you happy with the products/services we've provided? How can we improve?" For your employees, you should ask questions like, "What ideas do you have to make this a better workplace?", and, "Are you happy in your position?" Yes, asking questions like these might make you a little vulnerable as a business owner/manager, but it's important to hear from your customers and staff. Improving the quality of your business means doing some investigative work on your part. 
  • Break Down Your Business Bit by Bit and Find Ways To Make Improvements: Once you've started a dialogue with your employees and customers, take the time to break down everything your business does and find ways to make meaningful improvements. The improvements you make may be small and seemingly insignificant, but the cumulative positive changes in your business could end up being huge. 


By Jeff Thomas
on January 05, 2016

Everyone thinks they are compliant, until they find out they are not.  Nobody believes that a slight aberration here or a miscue there will cause any lasting harm.  When the FDA or client audit comes, all of those seemingly minor errors quickly add up to huge fines, delays and headaches for your company.  Without proper and relatively inexpensive compliance procedures, your firm could be in store for a huge penalty.

Panos Boudouvas
By Panos Boudouvas
on December 14, 2015

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.

By Jeff Thomas
on December 10, 2015

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.

By Jeff Thomas
on December 08, 2015

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.

By Jeff Thomas
on December 07, 2015

Anyone regulated by the FDA will find that an inspection is like a train. There is always another one coming down the track. It might not be for another day or it might be another year, but you know they are on their way. The FDA agents will show up, and they will inspect places at random. If you're stuck with the question, The FDA is at my door - What do I do?, don't panic. We have the answers for you.

What to Expect

When you know what to expect, you can feel better prepared for a visit. The FDA may or may not announce their arrival; some agents have been known to perform surprise visits. Whether the visit is planned or not, be sure to check credentials. All agents will have identification, and you should be presented with the FDA Form 482. This form clearly highlights what the inspector is allowed to inspect, what he or she is allowed to collect, and what areas are strictly off limits.

Be accepting of the inspection. This is not a reflection of your business - it is simply a federally regulated and necessary check. It's human nature to take an inspection a

By Giulia Umile
on December 02, 2015
Independent research in the Internet Data Corporation  (IDC) Whitepaper finds that vital data is probably more secure on the Amazon Web Service (AWS) cloud than it would be on a company's own in-house data center.

On the surface, this finding seems hard to believe. Cloud computing has developed something of a bad reputation for security. Moving beyond local security into public cloud space, private cloud or hybrid cloud architecture stretches the capabilities of traditional security tools. New security holes and blind spots are created that were not there before.

However, a recent Information Week article reinforces the findings in the IDC paper. The article points out that cloud security tools are rapidly developing and are reaching a point where cloud security tools will outmatch any type of non-cloud security architecture.

By Jeff Thomas
on December 01, 2015

Government requirements from the Food and Drug Administration to regulators such as the International Organization of Standards (i.e., ISO 9001) mandate that companies execute and thoroughly document employee training. These requirements ensure that employees know how to do their jobs in a way which will meet industry guidelines. The documentation provides a paper trail that can be audited to find gaps in the training. The system will minimize the risk of noncompliance with quality and safety standards.

Here's where the gap between automated computer-based documentation and paper based systems documentation becomes glaringly apparent. Post hoc explanations are of little value when an important gap in training leads to a mishap. The system auditor will look at the record. Auditors will need documented proof of compliance with training standards. Paper documents are hard to trace and collect and for the auditor "if it isn't documented, it didn't happen."