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4 Reasons Life Sciences Can Move Compliance Management to the Cloud

Cloud LS

The pace of technology is truly amazing, when you think about it.  The concept of "technology" as we know it is relatively new, and by new I mean it's only been in the last 50 years that we've embraced computers.  Jump ahead to today, and our smartphones are about 100,000 times the speed and data than the computer that landed men on the moon.  The rapid development of technology has evolved, and continues to evolve, on a daily basis.  For Quality and Compliance Management, especially in Life Sciences, this is good news.

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New FSMA Rules set the stage for Food Safety Management Software

Plugging in FSMA

There doesn't appear to be any summer vacation for the FDA this year.  Last week, the FDA put out two new proposals for rules as part of the Food Safety Modernization Act (FSMA, or "FizzMa" as some call it - sounds like a wonky cola to me).  These are proposed rules, not final rules, but their proposal puts into light the FDA's direction on ensuring Food Safety Management in the 21st Century, especially when you look at the context of automated food safety software solutions. We've spoken about the progress of the FSMA at length, this is just another interesting chapter in a long story.

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3 Reasons to Attend this Life Science Summit on Quality Management Systems


I am a firm believer in the power of reality.  A broad statement for sure, but in an increasingly digital world, it is nice to actually go somewhere and talk to other humans directly.  There's something a bit more satisfying in sitting down and listening to speakers talk, taking old school notes, and talking to industry peers.  That is why I am pushing this week's post to talk about this upcoming Life Science Summit on Quality Management Systems in Bridgewater NJ this March 12th, and the 3 reasons why you should attend.

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Integrating Regulatory Content to your Compliance Management Systems

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


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

fiscalcliff food

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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Automated Validation Interest Grows for Quality Management Solutions

validation books

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

blog foodsafety2

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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Using Quality Management Software Tools to Manage Recalls

recall management with the QMS

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


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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