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Middough and Automated Systems form Strategic Alliance

By Nels Hackl / March 2, 2017 /

Lake Bluff, IL – 2017-FEB-20 Automated Systems, Inc., a leading regulatory FDA compliance and systems automation-consulting firm and Middough Inc., a nationally ranked engineering, architectural, and management services company, have entered into a strategic alliance. ASI will ally with Middough to provide FDA compliance documentation and high-level software support. This alliance combines the strengths of…

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Automated Systems, Inc. Opens Southeast Office in Tampa Bay

By Nels Hackl / January 27, 2016 /

Lake Bluff, IL – 2016-JAN-27 Automated Systems, Inc. (ASI), is very pleased to announce the expansion of its business with the re-establishment of a Southeast Office based in Tampa, Florida. ASI has always believed that the best service is achieved and delivered locally. The new office in Florida will further enhance these business relationships, and…

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R+D Custom Automation and Automated Systems Become Strategic Partners to Better Serve the Life Sciences Industry

By Nels Hackl / December 17, 2015 /

Lake Bluff, IL – 2015-NOV-20 Automated Systems, Inc. and R+D Custom Automation, Inc., one of the area’s leading OEM’s for custom pharmaceutical and medical device manufacturing systems, have entered into a strategic partnership. ASI will become a strategic partner of R+D, in providing FDA compliance documentation and high-level software support to complement their fully integrated…

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ASI Sponsors 2017 Chicago Freedom Summit

By Nels Hackl / October 1, 2015 /

ASI is proud to work with our partner, AM560, to sponsor the 2017 Chicago Freedom Summit, to take place here in Chicago on November 11th, 2017. A distinguished panel of speakers will discuss what it will take move America forward in the current political environment.. More details, along with tickets, can be found at the…

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ASI Sponsors Operation Support our Troops

By Nels Hackl / June 10, 2015 /

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…

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ASI Radio Ad on AM 560 The Answer

By Nels Hackl / February 4, 2015 /

Listen 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]  

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Ray Rugebregt joins ASI as Director of Serialization

By Nels Hackl / January 6, 2015 /

Lake 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…

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21 CFR Part 4

By Nels Hackl / August 13, 2014 / Comments Off on 21 CFR Part 4

Part 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…

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Testing, Commissioning, Validation, Qualification, or Verification? A Brief History – Part 2

By Nels Hackl / December 20, 2013 / Comments Off on Testing, Commissioning, Validation, Qualification, or Verification? A Brief History – Part 2

We 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,…

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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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