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European Pharmaceutical Contractor
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Most IT professionals can recall the nervous anxiety they experienced at 11:59pm on 31st December 1999 in anticipation of what some thought would be the implosion of the computerised world. The great news is that Y2K came and went without incident, and IT professionals now reminisce about the good old Y2K days when computer system budgets were large and IT was king. We are among the many who believe that the reason Y2K came and went with no major consequence was not because it was a hoax, or that the risks identified which threatened computer systems were not real, but rather because most organisations took a systematic global approach to solving the problem.
21 CFR Part 11, more commonly known as Electronic Records/Electronic Signatures, or just 'Part 11', became law in August 1997. Part 11 defines the criteria under which the FDA will consider electronic records and signatures to be equivalent to hand-written records and signatures in highly-regulated environments that must comply with FDA requirements. In June 2000 the application of Part 11 was furthered when then President Clinton signed into law the Electronic Signatures in Global and National Commerce Act, which gave electronic signatures equivalent weight to handwritten signatures.
Although Part 11 had been law for more than two years when Y2K came around, it was lower down the list of priorities for most pharmaceutical organisations. Although not publicly stated, perhaps the FDA clearly understood that asking pharmaceutical organisations to pull their IT intellectual capital away from Y2K resolution to focus on Part 11 compliance could be detrimental to the industry.
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By Agostino Renna, Director of Life Sciences, Americas, and Matthias Maaz, Director of Life Sciences, Europe, at Johnson Controls, Inc.
Agostino Renna is Director of Life Sciences, Americas, with Johnson Controls, Inc. He is responsible for the development of global solutions for Johnson Controls' pharmaceutical, biotechnology and medical device manufacturing customers.
Agostino has spent his professional career developing facility-related solutions for life sciences companies, and his expertise in the application of FDA codes and validation guidelines to facility systems has been instrumental in managing costs and risks associated with facility compliance. He holds a degree in Mechanical Engineering, is a member of the International Society of Pharmaceutical Engineers and a facilitator of validation training.
Matthias Maaz, is Director of Life Sciences, Europe, with Johnson Controls, Inc. He has spent his career in the process control industry, working predominantly within the pharmaceutical/biotech industry in Germany and Switzerland until 1996, and then throughout Europe with global controls companies where he has been actively involved in developing solutions involving manufacturing execution systems (MES).
Matthias is currently responsible for developing life sciences solutions that integrate building management systems, HVAC, fire and security systems. He holds a degree in Automation Control.
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