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Steve Diedrich
By Steve Diedrich
on September 15, 2020

As part of the Quality Leaders Forum, we sat down (virtually) with Steve Diedrich for a primer on compliance vs. quality and how we might use Simon Sinek's framework of "finite and infinite games" to think about quality management. Register now for "Playing the Infinite Game in Quality," an interactive forum with Steve Diedrich. 

Jen Rajchel
By Jen Rajchel
on August 10, 2020

Actionable insights, confidence in completed tasks, and clear context are key to managing quality, so we're excited to share with you how our 2020.2 release can help. 

Celia Brown
By Celia Brown
on April 20, 2020

With travel bans and stay-at-home orders in place throughout the US and many other countries, life sciences companies are struggling to maintain GxP compliance under increasingly challenging circumstances. Employees are working remotely- and so are FDA inspectors and auditors. And new regulations are being rolled out frequently in hopes of expediting the drugs, devices, and vaccines supporting the treatment and prevention of COVID-19.  

Panos Boudouvas
By Panos Boudouvas
on April 07, 2020

Amidst this turbulent moment in our lives, with a global pandemic threatening us and our loved ones directly, and the specter of the coming economic recession already making waves, it is important to acknowledge that the hard work of life sciences development and manufacturing continues.  And while global regulatory requirements remain in place, many companies will be forced to stretch budgets further and possibly with fewer FTEs (due to cuts). And in a new complication-- teams will have to truly do more (or everything!) remotely-- manage policies and related training compliance, investigate deviations, manage change controls, host/conduct audits, sign/review documents, etc. 

Celia Brown
By Celia Brown
on March 31, 2020

As COVID-19 continues to spread across the globe, governments urge citizens to self-quarantine, and the U.S. economy faces an uncertain future, the life sciences industry is under more pressure than ever. Pharmaceutical and healthcare companies continue to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. And the FDA is rolling out updated policies to streamline the path to an effective vaccine and protecting the public from fraudulent products. 

Panos Boudouvas
By Panos Boudouvas
on March 17, 2020

A message to our community of customers and partners:

By Judy Carmody
on March 16, 2020

What are the two inspectional focus areas of regulatory agencies? Vendor oversight and data integrity. And agencies expect companies to take a risk-based approach, making them both quite daunting tasks. 

Celia Brown
By Celia Brown
on March 09, 2020

Karin Ashkenazi has more than 15 years of experience in the life sciences industry, including experience as a quality leader for clinical laboratories. Prior to joining ZenQMS last year to lead the Quality team, Karin worked in a laboratory with a paper-based quality management system (QMS). They were a small organization with a limited budget and so they initially felt that a paper-based system was their only option. 

Celia Brown
By Celia Brown
on March 05, 2020

Auditing a vendor starts long before you actually step into their office to perform the audit. For example, one of the first things you should look for when selecting a vendor is how willing they are to offer customers access to their platform- that may include performing demos of their solution, providing a sandbox environment or free trial, and responding to questions/ inquiries. 

Celia Brown
By Celia Brown
on March 03, 2020

Background

This U.S. based contract research organization (CRO),  was founded in the early 1980’s and has been committed to cancer research ever since. Quality is at the core of their business model given that their clients are life sciences companies and subject to regulatory compliance and good manufacturing practices (GMP.)  The company is audited multiple times each year by their clients and could be audited by the FDA at any time so it is critical that their Quality Management System is best-in-class. 

Celia Brown
By Celia Brown
on February 24, 2020

Data integrity is at the heart of quality culture and everything we do in the life sciences industry. It is a term that is often used synonymously with regulatory compliance but they are not actually the same at all.  Whether or not you are building- or intending to build- commercial products, the data you are generating will later inform commercial filings and applications that will add value for the business. And so that data- and the ability to defend that data all the way back to the source- is very important. 

Celia Brown
By Celia Brown
on February 20, 2020

Whether it’s your first or fifth or five hundredth audit, you can never be too prepared. We recently hosted a webinar on exactly this topic, hosted by quality and systems expert Ed Morris. Morris walked through tips for preparation for and day of your audit.  

Celia Brown
By Celia Brown
on February 19, 2020

Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. As Director of Quality, he led eQMS implementations from the ground up. Given Mr. Banerjee's deep experience in selecting and implementing eQMS solutions in the life sciences industry, we asked him to share some tips for those who are just getting started or in the midst of their purchasing decision. 

Celia Brown
By Celia Brown
on February 17, 2020

Regulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies. 

By Sourav (Neil) Banerjee
on February 04, 2020

An electronic Quality Management System (eQMS) is the key in today’s world for preventing quality issues that can have life or death consequences for patients. Companies with tremendous potential in the regulated pharmaceutical industry can fail badly if they do not implement the right eQMS. Yet organizations that easily implement automated systems for many other functions often do not have an adequate eQMS in place. This is usually because the need for an eQMS is not understood early enough.

Celia Brown
By Celia Brown
on January 27, 2020

Members of the Life Sciences Quality Leaders Forums met in Princeton, New Jersey to discuss the ins and outs of audit preparedness in the midst of an ever-changing regulatory environment. Ed Morris, President and CEO of The Morris Group, shared his expertise with the group, suggesting that the first step should be to thoroughly evaluate your organization’s Quality Management System (QMS) and identify any gaps.  

Panos Boudouvas
By Panos Boudouvas
on January 15, 2020

Intelligent Quality is an approach that is rooted in the digital transformation that we’ve seen across all lines of business over the past decade or so. The complex, modern organization has tools available in their ‘back office’ that offer data analytics and valuable insights to company leaders- enabling them to make informed decisions about their business strategy. We have seen the explosion of growth and advancement in CRM and ERP, for example, and there is no reason for quality and compliance teams to continue to use stone- age tools.  

Celia Brown
By Celia Brown
on December 18, 2019

Marken, a UPS company, is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments, and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 54 locations worldwide for clinical trial material storage and distribution. 

Celia Brown
By Celia Brown
on December 11, 2019

“We’ve never had a user specific action oriented system until Zen. Whatever you put in, you can also get out- that makes it a lot easier to track progress on individual users but also on a department level.”  

Celia Brown
By Celia Brown
on November 22, 2019
“When I discovered ZenQMS, I was excited to learn that it had all of the components we required and was cloud-based which would make it painless to roll out to our remote employees and contract manufacturing and packaging partners.” 

About Vizuri Health Sciences

Launched in 2009, Vizuri develops innovative personal care products, over-the-counter medicines, and prescription medicines by enhancing the benefits of proven, active compounds found in nature through the development of novel technologies and formulations. 

Panos Boudouvas
By Panos Boudouvas
on November 12, 2019

John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing  over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder.  That was just one of many times that he observed teams not taking a risk-based approach to systems validation. 

Panos Boudouvas
By Panos Boudouvas
on November 07, 2019

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.  

Panos Boudouvas
By Panos Boudouvas
on October 31, 2019

Janet Woodcock made headlines (again) by discussing the possibility of a quality rating system to aid transparency in her recent blog. But the devil is in the details when it comes to ratings for a site’s quality maturity.

By Judy Carmody
on October 01, 2019

Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.

Celia Brown
By Celia Brown
on September 25, 2019

The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future. 

Celia Brown
By Celia Brown
on September 04, 2019

 ZenQMS recently  hosted a live webinar featuring a presentation by Ed Morris, Managing Partner of The Morris Group and a well-known IT and Compliance expert.  If you missed it, there is a replay available on-line and I've written up a brief summary here:

Emily Ruth
By Emily Ruth
on August 27, 2019

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. 

Panos Boudouvas
By Panos Boudouvas
on August 20, 2019

I am frequently in meetings with quality leaders and regulatory experts where I find myself wishing I could share some part of the conversation or findings with a broader audience.  Something about the current state of affairs, best practice or just a really eloquent description of a pain point and how they are managing.  

Celia Brown
By Celia Brown
on August 13, 2019

“We’ve been able to reduce on-site audit time by more than 50% because we are able to provide auditors access to review documents in ZenQMS.”

Brendan Lawrence
By Brendan Lawrence
on August 08, 2019

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.

Celia Brown
By Celia Brown
on August 01, 2019

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. 

Celia Brown
By Celia Brown
on July 29, 2019

"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.”

Celia Brown
By Celia Brown
on July 24, 2019

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. 

Tim Reinhardt
By Tim Reinhardt
on July 12, 2019

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?

Panos Boudouvas
By Panos Boudouvas
on July 03, 2019

Effective  quality leaders know that securing executive support and buy-in are key factors  in successfully selecting and implementing an  eQMS. 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). 

Celia Brown
By Celia Brown
on June 11, 2019

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.

By Jeff Thomas
on June 21, 2016

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

By Jeff Thomas
on June 07, 2016

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

By Jeff Thomas
on May 31, 2016

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.

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 May 17, 2016

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

By Jeff Thomas
on May 11, 2016

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

By Jeff Thomas
on May 03, 2016

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

By Jeff Thomas
on April 26, 2016

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 does your organization suffer 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.

By Jeff Thomas
on April 19, 2016

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

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 April 07, 2016

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

By Jeff Thomas
on March 15, 2016

 

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.

By Jeff Thomas
on February 11, 2016

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!

Panos Boudouvas
By Panos Boudouvas
on January 19, 2016

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.

By Jeff Thomas
on January 15, 2016

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.

By Giulia Umile
on January 13, 2016

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.

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.

By Jeff Thomas
on December 21, 2015

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

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." 

Panos Boudouvas
By Panos Boudouvas
on November 23, 2015

What is the Cost of Poor Quality? Analyzing What Needs Improving to Save You Money.

Figuring the cost is of poor quality in your company is neither an easy or enjoyable task, yet it's necessary to factor into the cost of overall quality to manage compliance. The only way to get a complete 

picture regarding the cost of quality is by calculating the sum of both good quality and poor quality for a bigger picture of where your problem areas exist. It's nearly impossible to assemble this on your own without using an electronic quality management system (eQMS) to help you get organized.

With Quality Management Software (QMS), you can identify all quality costs in order to identify vulnerabilities. Because of the complexities involved in what could be costing your company money, you need tech that helps you piece everything together to find answers of why poor quality exists. 

In many cases, you could be losing money without knowing it in various areas you haven't yet audited. With that in mind, let's take a look at the cost of poor quality and why maintaining a higher percentage of good quality is a smart goal to set for the coming year to save you money.

By Jeff Thomas
on November 17, 2015

The life of a training supervisor in a paper-based system isn't an easy career when stuck in a situation that has no efficient way to manage a regulated environment. Your own training supervisor arguably has the most stressful job of all when you realize the magnitude behind keeping training records up to date. However, that's only starters once you place other aspects behind training management into perspective.

By Giulia Umile
on November 13, 2015

Paper-based quality management systems are fairly common, especially in small to mid-sized operations. Three years ago an estimated 80% of managers were using spreadsheets and word processors to manage their auditing and compliance systems. These systems require a steady flow of paper documents from office to office. Whereas, paper-based systems may be minimally sufficient for managing product and process quality, they are prone to error and significantly increase the risk of non-compliance when production is regulated. The rigidity of paper-based Quality Management systems makes them a bottleneck that impedes progress as a company grows.  

Problems with Paper Based Systems:

  • Poor document control. In a paper-based system documents are often opaque to all except the person filling them out.Any change in standard operating procedures means that a manager will have to go from office to office to track down the progress of documents that might be stuck somewhere in the review cycle. Manual documents can be prone to copy errors that are difficult to check. Such errors can make cause accidental compliance violation. 
By Jeff Thomas
on November 11, 2015

It seems many mid-sized companies still rely on paper-based quality management systems to maintain compliance of their documents. While these paper-based systems are fine for managing products
 
and quality, they usually fail in helping a company stay compliant. Improvements on documents also become more difficult to control using paper-based systems because of increasing document volume.

Your own company may still use papers and spreadsheets to manage all your documents, training records, plus corrective and preventive actions. When you strictly rely on your team working with these systems, you're playing extreme risk with mistakes. You're also wasting resources using paper and spreadsheets because of how much time gets involved managing documents.

Because you run a regulatory environment in your company, you really need to upgrade to something more efficient. Before you do, though, you need to understand what the true cost is of paper-based quality management systems.

You may not have complete awareness of how much money you're losing until looking into your company metrics. Once you find out, an electronic quality management system can end up being the rescue you need.

Controlling Your Documents

No doubt you've noticed how little control you have of your documents lately while in the process of making company changes. That's dangerous when all of your documents need control for regulations to avoid violation fines.

All of this stems from the review process for paper documents, which can take considerable time when having to check them individually. In a paper-based management system, a manager has to go through a more protracted review process to ensure all documents stay compliant.

Things become more complicated when employees have to edit documents manually. This only leads to more errors in the long run because of the excessive amount of documents needing managing.

For CAPA management, this also proves troublesome because there isn't any way to collectively see what document improvements took place.

Lack of Prevention Methods

Your quality manager may already have added stress trying to make sure every document adheres to compliance rules. Paper-based management systems just don't provide any way for those managers to track documentation problems and find ways to prevent it from happening again.

Preventative measures are an important role for quality managers to make sure major disasters don't happen. Without being able to properly track every document, you face serious risks like having to recall a drug, or even a death due to misinformation on your part.

It's time you gave your quality manager an easier time with an electronic quality management system that keeps collective track of all documents.

Lack of Metrics Available

There isn't any question that metrics are the most valuable source for all companies today. Without them, you're basically flying blind with what's really going on in your company. A paper-based management system can't provide timely metrics to determine what documents had corrections and which ones haven't.

While you may have metrics available in your company, far too many similar systems don't report until a week or month later. You need something with real-time analytics so you know what's happening hour-to-hour every day. Without catching a document that needs attention, it could go unnoticed for weeks before an error gets caught.

An Electronic Quality Management System as a Money Saver

Using a quality eQMS software can help your entire team get on the same page about document control and prevent any wasted time used to assure compliance. Wasted time is a major liability in all companies today as competition becomes fiercer.

Better management of your documents helps everyone use their time more wisely and prevents major disaster, which can already rescue you from the worst financial fallout.

For a fascinating look at the costs of Paper or to find out about our own eQMS software that can help you with document management, training management, CAPA's, and audits.click belowNew Call-to-action

Zen QMS offers a validated Quality Management System that can help you graduate from your paper QMS to an affordable, easily implemented cloud based QMS

Panos Boudouvas
By Panos Boudouvas
on November 09, 2015

 

Essentially the translation involves first, identifying the unnecessary costs of the enterprise’s current quality and compliance processes and second, demonstrating how to eliminate those costs by implementing a cloud-based eQMS system.

Identifying current process loopholes

To start the discussion, let us acknowledge that everyone connected with your enterprise works hard to manage quality and ensure compliance. The question for the CFO, then, is: are the processes in use sufficient to optimize cost savings?

Indications that there may be costly loopholes in your enterprise’s current system include:

  • reliance on paper reports and files;
  • silos of electronic files on various computers in different departments;
  • signs of duplicative efforts, especially with respect to risk management and/or audits;
  • corporate governance systems that are not aligned with quality, risk management, and financial systems; or
  • quality, risk management, and financial systems that are not linked.

How should you approach CFOs about costs associated with these loopholes? Why not have the finance team attach a dollar figure to each adverse event in the most recent fiscal year which can be traced to one of the loopholes listed above?

  • Time and data lost to the reliance on paper reports and files.
  • Time and data lost to searching for electronic files, comparing data on siloed files, eliminating duplication on siloed files, and ensuring complete information is available once the right files are identified.
  • The costs associated with personnel changes and finding or updating paper files as well as siloed electronic files.
  • Time lost to deduping files.
  • Adverse events unrecorded, partially recorded, recorded in duplicate, or recorded late.
  • Audit reports that are: lost, incomplete, or duplicated.
  • Unaligned strategies between corporate and mid-management levels leading to overlooked compliance tasks, duplicated tasks, partially completed tasks.
  • Unexpected costs associated with too many adverse events, inefficient use of staff time, new compliance needs, or new risks.

Once quantified, these loophole-related costs are guaranteed to attract the attention of CFOs who then will be attentive to suggested solutions.

The next step is to offer a plan to eliminate those costs: an eQMS system.

Closing loopholes to reduce costs

Every executive—from CFOs to CEOs—is driven to optimize value. They look for ways to maximize savings and boost returns on investments they have decided will make sense for the enterprise.

  • Reducing costs associated with quality control and risk management means closing current loopholes in the system by pivoting to an investment in an eQMS program.

Paper files, spreadsheets, and older quality control processes may have been adequate in an era when regulations and risks were much more predictable, but times have changed—and the systems on which an enterprise relies to manage quality and risk need to be up to meeting today’s new challenges.

Operating within a regulatory environment in which changes are the norm and a risk environment that turns life sciences enterprises towards continuous mine-evading tactics, CFOs are most likely to welcome an investment in an effective eQMS system that does three things:

  • enhances compliance,
  • reduces risk, and
  • comes as close as possible to eliminating adverse events.

An efficient eQMS system offers linked, transparent, aligned, unduplicated, and complete documentation and reporting for audits, risk management, adverse incidents, and compliance with minimum staff effort and maximum ROI.

The good news for CFOs

More cost-related advantages to an effective and efficient eQMS system include:

  • Adaptability to any size enterprise. CFOs need not fear paying for a system twice as big as they need.
  • No extra charges for access to the system by an unlimited number of staff. Say good-bye to seat licenses.
  • The right system coupled with strong tech support translates into little to no downtime, even for new users.

ZenQMS appreciates the concerns CFOs have and stands ready to assist by demonstrating the value of eQMS for your team. Let us know how we can help.

 

By Jeff Thomas
on November 05, 2015

Now that everyone has returned from RAPS and (hopefully) dug out of their own personal backlogs, we thought we'd take a minute to review what we saw, what we learned, and what we did at RAPS 2015

1) Use the RAPS App - We connected with a lot of people through that handy app. We got tagged and tagged people over the course of the conference 

2) Check into your hotel on time- We didn't get to our hotel until after 11:00 pm and were sent packing. Fortunately they comped the room.

3) Lunch is at 12:00. Arriving early gets you nothing.

Panos Boudouvas
By Panos Boudouvas
on November 02, 2015

Woeful stories from real people that validate why we started ZenQMS

We had a tremendous time at the #RAPS conference last week (thanks to all attendees for actually making a trade show fun!). But someone visited our booth with a story that just brought it all home for me.

Panos Boudouvas
By Panos Boudouvas
on October 23, 2015

Zen QMS  will be exhibiting and entertaining at the RAPS Regulatory Convergence October 26 and 27th, 2015. During the show we can be found in Booth 125 of the Exhibit Hall. Come by and in less than 60 seconds we can show just how we can help you "Keep Quality Simple".

Panos Boudouvas
By Panos Boudouvas
on October 12, 2015

I am, like most people, a creature of habit. Finding and keeping the same barber is a big deal for me. Mostly because I need all the help I can get. I was lucky to find 'Mike' a few years back-- an older Italian-American who still speaks broken English and reminds me of my dad.  The guy is solid.  I’ve never gotten a bad cut from him. Well, I had to get a haircut last week and Mike was not in town.  So I chanced it-- I jumped into Phil's chair and promptly got chopped.  And I am heading back to Mike the day he comes back to get a tune up. Why tell this story? 

By Jeff Thomas
on October 07, 2015

Our training partner, Pharma Consult Global is presenting a free webinar on new drug developments in Europe, North America and Latin America. 

By Jeff Thomas
on October 01, 2015

Last week a federal jury convicted Stewart Parnell of fraud, conspiracy and several other charges stemming from the Salmonella outbreaks caused by Parnell’s Peanut Corporation of America in 2008. Parnell was sentenced to 28 years in federal prison. While Parnell got 28 Years, Mary Wilkerson, an employee who held titles of Office Manager, Quality Assurance Manager and Receptionist got 5 years.

By Jeff Thomas
on June 01, 2015

​Thanks to Michael Wienholt for publishing an unsolicited post about our “refreshing solution to a persistent problem” on LinkedIn.

By Jeff Thomas
on April 15, 2015

In a recent client audit, we were asked to demonstrate our ability to support worldwide operations. We knew that people from around the globe were accessing ZenQMS every day but we were delighted to find that in just the last 30 days, we’ve had access from approximately 5 Continents, 50 Countries and 300 Cities. When you look at this data alongside our 100% uptime for the past 24 months, it is clear that you will struggle to find a more available system to meet your needs!

Panos Boudouvas
By Panos Boudouvas
on April 08, 2015

We spend a great deal of time focusing on data security in our applications, and picking the right infrastructure partner is a critical consideration. Forrester research just put out an updated analysis worthy of your review.

Panos Boudouvas
By Panos Boudouvas
on April 07, 2015

Introducing ZenQMS: Elevating Your Quality Compliance Profile Just Got That Much Easier!

On 5-January-2014 I made some promises about our exciting plans for 2014: