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Jul 8, 2015

It’s Hot in Here—Quality, Compliance, and Romance

Editor, MasterControl Insider

Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system.

Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

It’s no wonder that two of my colleagues asked me (read: it sounded very much like a dare) to link romance with quality management system. It took me about 60 seconds to realize that, in fact, establishing a QMS or overhauling an existing system is similar to finding and nurturing a romantic relationship.

Passion Knows No Bounds

You can be passionate about your high school sweetheart whom you married, or the garden you’re currently landscaping. Maybe you’re spending your weekends perfecting your golf swing or training for a triathlon . And if you’re a quality or regulatory professional, your passion could very well be quality and compliance. Bottom line: when you love someone or something, you want to do your best for this passion of yours.

If your organization is planning to automate your paper-based system or revamp a homegrown system, you should spend as much attention as befitting your passion. I dare say—you have to find a system you can fall and stay in love with. After all, you and your organization will use this system for years to come. You’re going to need a good “relationship” with your system to ensure quality, compliance, and efficiency.

So, while everybody is away on vacation, get a head start and do your software research now. Going back to our romantic analogy, choosing the right EQMS is a little bit like dating. You will find all kinds of providers offering the latest and greatest technology. Instead of playing the field and risking a broken heart, heed these warnings so you’ll end up with your own happily-ever-after story.
This article is related to the Whitepaper: What is the True Cost of Not Having an eQMS?.To get the full details, please download your free copy.

#1 Don’t Settle for Love at First Sight

When you fall in love at first sight, your heart pounds, your stomach flutters, and you simply melt. It’s great for romance, but not so for quality and compliance. Don’t fall for the first software you’re “attracted” to. Evaluate your company’s needs and research your user requirements. If your organization has multiple high-priority needs—such as managing thousands of documents, conducting customer or regulatory audits, and training employees regularly on critical documents—you should look at getting an integrated platform of best-of-breed applications to address all of those needs.(1)

If you’re focusing on a particular problem area (e.g., CAPA or document control), you should evaluate point solutions, but be sure to choose a scalable solution that will give you the ability to expand your system to cover other quality processes.

#2 Don’t Fall for the Gorgeous Bad Boy

In romance novels, you often find a heroine who falls for a gorgeous bad boy or the rich-but-roguish duke. The entire book is then dedicated to taming him. The equivalent of the bad boy in the world of EQMS is the latest shiny tool being touted in the market. Don’t fall for it.
You want a system that suits your company and can be leveraged throughout your organization. The solution must have the right features and support services for the right price for you to be compatible over the long haul. It must address the specific regulations, standards, and requirements that apply to your products or services.

#3 Don’t Settle for a Summer Fling

In romance novels, the love-at-first-sight encounter we talked about in #1 must turn into something more enduring to have a satisfying HEA conclusion. The same thing goes for quality software. You want a system that can grow with your organization through the ebb and flow of business.

Your paper-based or homegrown system is inexpensive and it may suffice for now. But how long is your document-approval cycle? What is the cumulative cost of quality issues such as failed audits or scrap and rework? See how you can generate significant cost savings over the long haul if you automate your system and improve your processes now.

Find Your HEA

Just like any relationship, don’t rush into a commitment. When you find a system you like, ask for a reference. Talk to a company similar to yours that’s using the software. If you can, visit the facility and observe how people use the software on-site. In romance, there’s such a things as “happy for now” or HFN. Perhaps it takes more than a book to tame the handsome bad boy all the way to the altar, but at least he has given up his philandering ways. It’s one way to continue the story; the romantic hero will finally marry the heroine in the sequel.

In quality and compliance, HFN is not good enough. You don’t want to wait for a sequel to get what your organization needs. Go find that perfect EQMS now and live happily ever after sooner than later.

Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University. Her debut romance book, In His Corner, was published under her pen name, Vina Arno, by Lyrical Press/Kensington Publishing Corp.

Reference:
(1) To learn more about MasterControl’s All Access best-of-breed platform, go to:
http://www.mastercontrol.com/solutions/all_access.html






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