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FDA Enforcement Continues to Rise

Posted by hrs.jmorgan on May 28, 2013 at 3:25 PM Comments comments (31)

While news reports discuss the diminishing funds for many government programs, it seems that the FDA remains unaffected.  In fact, FDA Warning Letters continue to rise in number, indicating that the need for compliance to the regulations is more important than ever.  While it may be human nature to take on a "Big Brother is out to get us" attitude, the facts remain that the recipients of these enforcement actions have simply had deficiencies in their Quality Systems.

The rippl...

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QSDLease - Document Control Cost Savings

Posted by hrs.jmorgan on December 17, 2012 at 4:30 PM Comments comments (3)

QSDLease is a service provided by Hawai’i Regulatory Services and is extremely helpful and efficient for small companies, start-ups and 21 CFR 111-regulated companies.  Small clinics and physicians' offices can even benefit.

Here'show it works:

  • Hawai’i Regulatory Services will provide an interview with the client using a form to determine the extent of the business Quality System needs.
  • The client returns the form to Hawai’i Regulatory Services...
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THE GAP ANALYSIS - Questions and Answers

Posted by hrs.jmorgan on January 12, 2012 at 5:45 PM Comments comments (0)

What is a GAP Analysis?

A GAP Analysisis a tool that helps a company determine the steps to be taken in moving from acurrent state to a desired future-state. This helps provide the company withinsight into areas which could be improved. At its core are two questions:"Where are we?" and "Where do we want to be?"


What does it consist of?

A GAPAnalysis consists of two phases. PhaseOne involves determining, documenting and approving the variance betwee...

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Virtual - A Huge Cost-Control Benefit

Posted by hrs.jmorgan on January 12, 2012 at 5:40 PM Comments comments (3)

Today's economy means everything must be viewed from a new perspective.  The term "Bang for the Buck" was just a buzzword with little substance over the past 15 to 20 years.  Now it's a matter of survival.



In the past, when firms required outside assistance with start-up, new challenges or maintenance of old challenges, they hired consultants for on-site and often full-time.  In many cases, the "hired gun" was flown in several times a month, pro...

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