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The life of a Training Supervisor in a paper-based system; Only Superhereos need apply.

Posted by Jeff Thomas on Dec 1, 2015 11:29:26 AM

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." 

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Topics: Blogs, eQMS, Manual QMS

Good quality, bad quality; two sides of the same coin.

Posted by Panos Boudouvas on Nov 23, 2015 11:04:21 AM

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.

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Topics: Blogs, Quality & Compliance, eQMS

Paper posts a penny; A pencil costs a dime --Together that's a fortune

Posted by Jeff Thomas on Nov 11, 2015 3:29:44 PM

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

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Topics: Blogs, Cloud / SaaS, eQMS

From the vocabulary of Quality to the language of Finance

Posted by Panos Boudouvas on Nov 9, 2015 4:00:04 PM

 

Busy CFOs intent on a bottom-line focus may be forgiven for not immediately seeing the financial benefits of a technology investment that will upgrade quality control and compliance while reducing associated costs.

Let’s make it easier for CFOs to say “yes” to pivoting to an eQMS system by looking at how to translate the eQMS language to finance.

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.

Paper Costs What?  Download now to find out!

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Topics: Blogs, Cloud / SaaS, eQMS

Rejection Sucks - A reminder of why we started ZenQMS

Posted by Panos Boudouvas on Nov 2, 2015 11:02:00 AM

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.

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Topics: Blogs, Quality & Compliance, Cloud / SaaS, eQMS

ZenQMS is Hiring again!

Posted by Jeff Thomas on Oct 14, 2015 5:43:55 PM

ZenQMS is hiring again. We are currently looking for a Director of Client Services to join our growing team. We're looking for a team player who can grow with the company as we continue to expand our market position.

If you'd like to be involved with a company that is changing an industry, take a closer look at us

You can read more about the position and apply here.

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Topics: Blogs

We fix bad haircuts!

Posted by Panos Boudouvas on Oct 12, 2015 10:25:00 AM

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? 

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Topics: Blogs, Quality & Compliance, Cloud / SaaS

Companies and Executives are being held accountable. Are you and your QMS ready?

Posted by Jeff Thomas on Oct 1, 2015 7:30:00 AM

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.

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Topics: Blogs, Quality & Compliance, eQMS

Our clients are everywhere, and they can log in from, well, everywhere!

Posted by Jeff Thomas on Apr 15, 2015 11:02:00 AM

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!

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Topics: Blogs, Quality & Compliance, Cloud / SaaS, eQMS

ZenQMS offers  a validated Quality Management System (QMS) with fast implementation and full features. Whether you are trying to improve your paper based QMS or build a new electronic Quality Management System, ZenQMS can help you implement an affordable QMS in less time and for less money that you might think.
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