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ASI is a proud sponsor of the AM 560 WIND Radio 2015 Golf Outing fund raiser for Operation Support our Troops, whose mission is to support the morale and well-being of American forces by providing comfort, resources and education to them and their families both while they are deployed in harm’s way and after their…
Read MoreListen for ASI’s new radio ad on AM 560, The Answer. The ad will play during the month of February 2015. You can also listen to the ad right here: [cincopa AkOAuSc_k-v3]
Read MoreLake Bluff, IL, 01/05/ 2015 – Automated Systems, Inc. is pleased to announce that Mr. Ray Rugebregt has joined Automated Systems, Inc. as Director of Serialization. Mr. Rugebregt comes to Automated Systems, Inc. with over 20 years of experience in high level engineering, FDA compliance, and project management roles. Throughout his career he has succeeded through…
Read MorePart 4 was added to 21 CFR, effective July 22, 2013. This is a new regulation, intended to help identify and clarify which rules apply to Combination Products. It provides regulatory framework and defines which Parts of 21 CFR apply to facilities that manufacture single-entity or co-packaged combination products. In the past manufactures of Combination…
Read MoreWe left off in Part One, with spiraling costs for commissioning and qualification activities. Some companies, under regulatory pressure, would perform a full IQ/OQ for commissioning, then a “dry-run” IQ/OQ, and then the “real” IQ/OQ. That is three full qualification efforts! Even with all this expensive paperwork, the startup experience was rarely improved. Generating, approving,…
Read MoreRisk 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…
Read MoreThere 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…
Read MoreThe 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…
Read MoreIn 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…
Read MoreFDA 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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