Integrating Regulatory Content to your Compliance Management Systems

[fa icon="calendar'] Wed, Feb 06, 2013 / by Tim Lozier

These days, the term "real-time" has almost become useless as a descriptive element.  Everything we do in our digital lives is real-time – Web, News Feeds, Blogs (ahem), Twitter and other Social media all provide us with up-to-the-second information on who is eating what, where and with whom.  In business, the concept of real-time winds its way into manufacturing operations, with up-to-the-minute inventory and inspection information.  Compliance Management is now slowly coming around to bring in more real-time capabilities to business systems.

But let’s back up a second – why are we striving for real-time?  What happened to the good old days, when it was good enough just to know how we’re performing within a day?  When did it become necessary to keep tabs on things so closely?  The reality is that the world is simply moving faster in terms of information.  Our operations are streamlined, our supply chains are bigger, our products diversified, our competition is ruthless.  We move faster because if we don’t, then someone else will jump in and push us out of business.  The pace of business is what keeps us moving fast, and that requires we respond to data faster.  We need the data as it happens because we can’t afford not to have it.

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EHS Management Enterprise Risk Management FDA Compliance

And So It Begins: New Rules from the FDA on Food Safety Management

[fa icon="calendar'] Fri, Jan 11, 2013 / by Tim Lozier

It's a new year, and with it comes new and exciting challenges.  Have you ever got that feeling when you come back from vacation and you missed something, then you scour the Internet and speak to colleagues about what you missed, and desperately try to wrap your head around what's going on?  I got that feeling when I jumped into my inbox and saw this:  "FDA Offers Broad New Rules to Fight Food Contamination".  Well, I put my Food Safety Management hat on and started reading - here's what I think:

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FDA Compliance Food and Beverage Safety

The Fiscal Cliff's Impact on Food Safety Management and the FSMA

[fa icon="calendar'] Fri, Dec 07, 2012 / by Tim Lozier

I've only been peripherally following the political world in the past few months.  There was apparently an election I'm told, and after the election we have the Mayan apocalypse and our own apocalyptic cliff to fall off of. (I was without power for a few weeks, so all this is coming as new to me).  In case you are like me, the fiscal cliff is a series of tax cuts that are set to expire at the end of the year.  It also would mean that spending cuts would take effect, which would have an impact specifically on Food Safety in the United States. 

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FDA Compliance GFSI HACCP Food and Beverage Safety

Automated Validation Interest Grows for Quality Management Solutions

[fa icon="calendar'] Fri, Sep 14, 2012 / by Tim Lozier

There's the old saying, "Don't knock it until you try it."  My daughter was convinced that broccoli was yucky, and she refused to eat it.  No matter what I tried - burying it in her mashed potatoes, dousing it with maple syrup, or liquefying it and putting it in her chocolate milk - she wouldn't go for it (ok, last one was fake).  Then, one day she saw her friends eating it, and they didn't seem to have a problem with it, and she decided it was time to try it again.  After that day, there is no looking back - she loves broccoli, and I no longer have to fight it out with her at the dinner table.

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Quality Management FDA Compliance

All I Need to Know About Food Safety Management I Learned in Kindergarten

[fa icon="calendar'] Fri, Aug 03, 2012 / by Tim Lozier

Food Safety and Food Quality are growing topics in the industry and within regulators.  Whether it’s implementing one of the GFSI schemes, getting the latest FSMA updates, or just evaluating the best practices solutions on the market, the concept of Food Safety Management is at the forefront of the discussion.  It seems that with each new trend and development that comes into view, the complexity tends to grow along with it.  Just for fun, let’s simplify the discussion:

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FDA Compliance Food and Beverage Safety

Using Quality Management Software Tools to Manage Recalls

[fa icon="calendar'] Fri, Jul 13, 2012 / by Tim Lozier

There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing Recall Management. Let's face it—no one likes talking about recalls; there is no positive side to recalls, and certainly no one "wins" when a product is recalled. This is a double whammy when you are a medical device manufacturer—not only are you recalling a defective product, but you are also facing regulatory scrutiny and potential customer endangerment. So when I speak about medical device recalls, many are apt to have a system in place to manage processes in the unfortunate event of a recall. The critical factor in this case is what system is best suited to effectively and efficiently manage the recall process?

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Quality Management FDA Compliance Medical Devices

Sneak Preview: Complaint Handling and the Risk-Based QMS - Seminar

[fa icon="calendar'] Thu, Apr 19, 2012 / by Tim Lozier

Next week (April 24, 2012 at 8:30am ET to be more specific) we will be hosting our 3rd Annual Life Science Seminar in lovely Waltham Woods in Waltham, MA (wicked lovely).  This will be our third year doing this great event, and with each year, we hope to provide a venue to learn and share about the various topics in the Life Science community.  This year we have speakers from EtQ, Kimberly-Clark Corporation, and Celgene Corporation.

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Quality Management FDA Compliance Medical Devices eMDR MedWatch Life Sciences

3 Things you Need to Know about Validating QMS in the Cloud

[fa icon="calendar'] Thu, Mar 29, 2012 / by Tim Lozier

As technology evolves, more companies are looking for easier ways to manage their IT infrastructure and, in turn, their Quality Management System (QMS).  First came the client-server (thick client); then came the Web client(thin client); and now Software as a Service (SaaS) (supermodel thin client).  With the first two, the key component was the hardware.  It was always known that if you wanted software, you had to put it on a box, and someone had to maintain that box.  In this new technological era, IT is tired of maintaining your hardware;  they are looking for ways to deploy the QMS in the "cloud" - the hosted realm where server farms enable virtual operating environments to "float" and draw what bandwidth is needed to make the software work. 

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EHS Management Quality Management FDA Compliance Cloud

FDA FSMA Regulations Delayed: Don't Wait for Food Safety Management!

[fa icon="calendar'] Fri, Feb 24, 2012 / by Tim Lozier

Last year, we all waited with anticipation when the Food Safety Modernization Act was signed.  This marked an evident step forward in the regulation of Food Safety from the FDA, and many saw this as a progressive move in the right direction.  We spoke on this act, and illustrated the long road ahead for regulations.  It seems, however, the road is a bit longer and a bit bumpier than expected.

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FDA Compliance HACCP Food and Beverage Safety

5 Things the FDA must do for Food Safety Management in 2012

[fa icon="calendar'] Thu, Jan 19, 2012 / by Tim Lozier

The title of this blog really should be "5 Things the FDA Probably Won't do for Food Safety Management in 2012."

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FDA Compliance GFSI Food and Beverage Safety

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