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The PDF file has to be opened with Acrobat Reader. to install Acrobat Reader without any costs. |
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| Does Quality Risk Management have value? |
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| The pharmaceutical industry urgently needs to further manage and control its current drug discovery and development processes using Quality Risk Management. Valuable lessons can be learnt from the medical devices industry
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Author
Henrik Johanning, QAtor, and
Asger Dahlgaard, QA director, Coloplast A/S
Published
PTE December 2007
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| Optimizing resources and minimizing risk |
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| An electronic object-based approach towards validation is forecasted to be the upcoming validation paradigm supported by reliable web-based technology, organizational focus on risk management and overall enterprise effectiveness.
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Author
Henrik Johanning
Published
PTE October 2007
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| A risk-based approach to biopharmaceutical manufacturing |
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As the biotechnology industry has seen 2006 kick-off with big pharma pushing its way in, the industry urgently needs to transform its current drug discovery and development processes. This knowledge era is focusing on strong collaboration and both interdependency and individualization demanding new approaches and technologies.
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Author
Henrik Johanning
Published
PTE July 2006
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| Why use LIMS and related software? |
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Exactly how good are they?
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Author
Christian Stage
Published
PTE May 2006
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| Narrowing in on spreadsheets |
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Spreadsheets are great, but do you know their limitations?
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Author
Anders Keldsen
Published
PTE April 2006
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| Using computer baselines |
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In an age of increasing regulation and monitoring, the ability to accurately and reliably track, manage and record changes to systems is paramount. This article looks at how computer baselines can facilitate this, and shows some in-house benefits too.
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Author
Christian Stage
Published
PTE February 2006
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| Like-for-Like Exchanges |
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The definition of which devices can be exchanged for others
without revalidation is somewhat blurry. The same is true when it
comes to computer systems.
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Author
Christian Stage, QAtor
Published
Pharmaceutical Technology October 2005
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| Does 21 CFR Part 11 provide any benefits |
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Everybody seems to complain about 21 CFR Part 11, but it does
actually provide some worthy advantages, assuming we are able
to build the appropriate systems around it.
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Author
Christian Stage, QAtor
Published
Pharmaceutical Technology August 2005
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| Proactive quality assurance |
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The FDA (U.S. Food and Drug Administration) has announced that
they wish to carry out an inspection - the next couple of months
will be busy. All documents are to be analysed, checked, updated,
amended and not least produced.
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Author
Knud Meldgaard
Published
Medicon Valley March 2004
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