JVT Journal Articles
Vol. 21, Issue 2, Aug 2015

Ivan Soto
This paper will discuss the typical challenges faced in enterprise system validation projects, and provide ideas and solutions to address the issues faced during these projects. The implementation of enterprise systems can be quite challenging for companies in the pharmaceutical industry. Enterprise systems are global systems that may impact...
Tim Sandle
The new guidance is welcome. It offers a clear signal to the industry as the FDA expectations for analytical methods and data presentation in support of new drug applications. While detailed, the document offers a framework that is less prescriptive. It allows the user to make some risk-based decisions on test requirements.
Valarie King-Bailey, M.B.A.
Computer systems innovation is an ongoing fact of life. Businesses are now more productive than ever but have higher risk cybersecurity issues. Further, computer systems validation activities are often still conducted on paper and include inefficient wasteful practices. This paper discusses cybersecurity and validation, green “paperless”...
Tim Sandle
Compressed gas sampling for microorganisms is an important part of contamination control assessment. This paper addresses topics related to microbial assessment of compressed gases. These include gas purity including moisture considerations, sterile filtration, compressed gas standards, microbial contamination, microbial survival, sampling and...
Christopher H. White
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Lizzandra Rivera González
Data integrity has become an increasingly important topic at conferences and workshops related to the pharmaceutical, biotech and medical device industries. This paper will discuss an innovative approach that defines data quality in terms of data integrity and data management. Pragmatic suggestions for measures to improve data quality are...

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