It may come as a surprise to many of you working outside the pharmaceutical industry that there is no formal quality system defined in the regulations. If you work in a laboratory accredited to ISO 17025 (for testing and calibration laboratories), or an organization that works to ISO 9000 or a variant thereof, you will know that the heart of the quality approach is a quality management system (QMS).
Otherwise known as the DIA’s Red Apple Document, one of the industry's oldest guidance publications is finally overhauled R. D. McDowall One of the oldest guidance documents for computerized system validation is entitled Computerized Systems Used in Non-Clinical Safety Assessment, otherwise known as the Red Apple Document. A new version was published in May 2008
Pertinent to specific techniques, these requirements rely heavily on the manufacturer R. D. McDowall USP on AIQ is effective from August 2008. It was developed from an American Association of Pharmaceutical Scientists meeting in 2003. Through a white paper published in 2004 and incorporation as a potential USP general chapter in 2005, cycles of comment and revision have followed to the final version that is now effective.
A very practical and useful document with some interesting approaches R. D. McDowall The Working Group on Information Technology (AGIT in German) is a collaboration of Swiss inspectors and experts from the pharmaceutical industry working to Good Laboratory Practice. This group has published four very practical and useful guidance documents on IT
The world needs good teachers — maybe you can help Rob Farber I would like to focus on how we educate and bring more excellent technical people into HPC. The people at Open Educational Resources (OER) are offering the HPC community the opportunity to educate the next-generation workforce with their Open Education Cup competition
Pen-based computing in the laboratory Bill Weaver, Ph.D This past summer of 2008, we searched for a PDA replacement for use by our new batch of sophomores. The university had no plans to distribute and support iPhones (much to the dismay of the students). However, after some sleuthing, we discovered the logical successor to the PDA — a digital “smartpen”
The title here should include “on a Number of Levels,” as this simple text has so much to recommend it. No, it is not watered-down statistics! It is a practical guide to quickly getting the reader up to speed on those items most used in describing data, performing hypothesis testing and conveying some of the more fascinating aspects of statistics in research
SAPPHIRE LIMS Release 5 consolidates functionality typically found in multiple laboratory systems, providing an enterprise platform
China’s increasing role in the global informatics landscape Randy C. Hice In the final analysis, China, even with some of the economic shine slowly aging to a not-as-explosive patina, is integral to every facet of world economics, and we can expect that the trend toward global informatics enterprises will certainly touch China from a great many angles
Computerized system regulations and guidance for the pharmaceutical industry have seen quite a few changes (part 2 of 2) R. D. McDowall This special section takes a look at what is happening in the regulated world with regard to Swiss Working Group on Information Technology (AGIT) Validation Guidance, United States Pharmacopeia (USP) Analytical Instrument Qualification, Good Laboratory Practice (GLP) Guidance for Computer Validation, Quality...
Known as Firefly, a new small satellite mission is designed to help solve the mystery of the most powerful natural particle accelerator in Earth's atmosphere
Astronomers have used light echoes as a time machine to unearth secrets of one of the most influential events in the history of astronomy — a stellar explosion witnessed on Earth more than 400 years ago
The world's most precise clock, on which all time-keeping and navigation systems are based, might be made as small as a wristwatch with a new design.
In developing a model to explain the motion of atoms in a magnetic field, scientists have overcome a decades-old obstacle to understanding adiabaticity, a key component of magnetic resonance
Randy C. Hice Why point informatics solutions are an endangered species Among global companies, the informatics landscape is burgeoning while the footprint of applications is shrinking by centrally serving applications to harmonized informatics architectures