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.
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.
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.
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.
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
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.
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.
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".
Topics: Cloud / SaaS
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?
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!