Enterprise Quality Management Software Blog | FDA Compliance

EHS Management, Enterprise Risk Management, FDA Compliance

Integrating Regulatory Content to your Compliance Management Systems

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.

By Tim Lozier on Wed, Feb 06, 2013

EHS Management, Enterprise Risk Management, FDA Compliance

Integrating Regulatory Content to your Compliance Management Systems

These days, the term "real-time" has almost become useless as a descriptive element. Everything we do in our digital lives...

By Tim Lozier on Wed, Feb 06, 2013

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FDA Compliance, Food and Beverage Safety

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...

By Tim Lozier on Fri, Jan 11, 2013

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FDA Compliance, GFSI, HACCP, Food and Beverage Safety

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

I've only been peripherally following the political world in the past few months. There was apparently an election I'm...

By Tim Lozier on Fri, Dec 07, 2012

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Quality Management, FDA Compliance

Automated Validation Interest Grows for Quality Management Solutions

There's the old saying, "Don't knock it until you try it." My daughter was convinced that broccoli was yucky, and she...

By Tim Lozier on Fri, Sep 14, 2012

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FDA Compliance, Food and Beverage Safety

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

Food Safety and Food Quality are growing topics in the industry and within regulators. Whether it’s implementing one of...

By Tim Lozier on Fri, Aug 03, 2012

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Quality Management, FDA Compliance, Medical Devices

Using Quality Management Software Tools to Manage Recalls

There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing ...

By Tim Lozier on Fri, Jul 13, 2012

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Quality Management, FDA Compliance, Medical Devices, eMDR, MedWatch, Life Sciences

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...

By Tim Lozier on Thu, Apr 19, 2012

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EHS Management, Quality Management, FDA Compliance, Cloud

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

As technology evolves, more companies are looking for easier ways to manage their IT infrastructure and, in turn, their ...

By Tim Lozier on Thu, Mar 29, 2012

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FDA Compliance, HACCP, Food and Beverage Safety

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

Last year, we all waited with anticipation when the Food Safety Modernization Act was signed. This marked an evident step...

By Tim Lozier on Fri, Feb 24, 2012

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