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Risk Management

By Nels Hackl / December 18, 2013 / Comments Off on Risk Management

Risk management is a growing discipline within the Life Sciences industry.  With the introduction of FDA’s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System), drug manufacturing entered a new era of risk management. There is now an expectation that organizations have a high…

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Experienced Workers Deliver

By Nels Hackl / December 17, 2013 / Comments Off on Experienced Workers Deliver

There was a fantastic post on the Harvard Business Review Blog Network today. It validates everything we have been preaching for years here at Automated Systems Inc.  The article takes American business to task for its false assumptions about well educated, older workers. The article states: Then there’s a set of employer beliefs about workers…

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Choosing the Correct Storage Method in Wonderware Historian

By Jozsef Megyeri / September 4, 2013 / Comments Off on Choosing the Correct Storage Method in Wonderware Historian

The most frequent request I seem to get from our customers, when creating a new Wonderware Historian tag, is to describe the different storage methods that could be selected for the tag.  In this blog entry, I would like to explain the available storage options for tags and the various situations where one or the…

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Testing, Commissioning, Validation, Qualification, or Verification? A Brief History

By Nels Hackl / August 29, 2013 / Comments Off on Testing, Commissioning, Validation, Qualification, or Verification? A Brief History

In the good old days, when I was a field service engineer, I tested things.  Anything I didn’t test, usually came back to bite me.  A piping & instrumentation diagram and electrical/pneumatic schematics, along with a good highlighter, were typically all that was needed to ensure that everything was tested and that a working system…

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Quality systems? We don’t need no stinking quality systems.

By Nels Hackl / July 26, 2013 / Comments Off on Quality systems? We don’t need no stinking quality systems.

FDA warning letters are always interesting reading. Typically, these warning letters describe quality systems which, despite good intentions, have gone awry. However, sometimes the warning letters are simply shocking.  This is the case with this letter recently sent to Wockhardt.  It’s hard to know where to begin with this one, but let’s start here: For…

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Pharma Serialization: A Growing Trend for ASI

By Nels Hackl / July 26, 2013 /

ASI is now working with 2 Fortune 200 pharmaceutical companies to implement product serialization programs. With regulatory requirements already on the books in many countries and becoming more certain in the U.S, the push is on to upgrade the industry’s packaging lines. Companies not ahead of the curve will be left scrambling for support and…

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Finding Talent

By Nels Hackl / June 27, 2013 / Comments Off on Finding Talent

Finding talent for our life sciences clients makes up the majority of my work day.  At ASI we evaluate talent the old fashioned way; we talk to candidates, their peers, and their employers.  We look for knowledge of first principles, energy, drive, integrity, good judgment and good character.  In contrast, it seems many of our…

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How do you define quality?

By Nels Hackl / June 6, 2013 / Comments Off on How do you define quality?

I recently received an email from the ISPE.  The email asked the following question: “If the FDA asked you tomorrow, “How do you define quality?” how would you answer?  How would you prove your answer? One way to ensure product quality is to define it as an industry, a definition that until now has not been explored.”…

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Precision Pays When Responding to an Auditor

By Nels Hackl / May 29, 2013 / Comments Off on Precision Pays When Responding to an Auditor

The Wall Street Journal At Work Blog has an interesting post today.  The post related to salary negotiations, but I believe it applies to audit responses as well. In a nutshell, the sited study claims that numbers with more significant digits convey credibility and understanding, while rounded numbers seem arbitrary and not well thought out. …

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Safety Lessons

By Nels Hackl / November 20, 2012 / Comments Off on Safety Lessons

This excellent post by Derek Lowe over at the In the Pipeline Blog is a stark reminder that we all work in a dangerous business. The analysis illustrates all of the classical causes of disasters: Complacency- This disaster happened on the 175th run. Ignoring Close Calls- Past close calls were never investigated. Exothermic Reactions- No need to say more.…

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