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Determination of 13 Organic Toxicants in Human Blood
Researchers have utilised liquid-liquid extraction coupling HPLC-MS/MS to identify and quantify organic toxicants in human blood.
Accessing Metabolic Information with Mass Spec
Scientists at the Helmholtz Zentrum München have developed a new mass spectrometry imaging method which, for the first time, makes it possible to analyze hundreds of metabolites in fixed tissue samples.
Unravelling the Roots of Insect’s Waterproof Coating
Researchers have identified the genes that control cuticular lipid production in Drosophila, by performing an RNAi screen and using Direct Analysis in Real Time and GC-MS.
Massive Helium Discovery a "Game Changer" for Medical Industry
A new development is gas exploration has yielded the discovery of a huge helium gas field, which could help relieve the dwindling supply.
Unidentified Spectra Detector
New algorithm clusters over 250 million spectra for analysis, such that millions of unidentified peptide sequences can be recognised.
Making Metabolite Identification More Efficient
Metasense combines the industry's most-comprehensive metabolic transformation prediction with efficient analysis of LC/MS analytical measurements to identify, visualize, and report chemical biotransformations.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
A New Tool Brings Personalized Medicine Closer
Scientists from EPFL and ETHZ have developed a powerful tool for exploring and determining the inherent biological differences between individuals, which overcomes a major hurdle for personalized medicine.
Rapid Retrieval of Live, Infectious Pathogens from Clinical Samples
An engineered pathogen-binding protein enables rapid isolation of infectious bacteria from joint fluids and accelerates their identification.
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Considerations When Validating Your Analyst® Software
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SCIEX

The FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”1 Note the terms “objective evidence” and “particular requirements.” Confirmation of conformity to user needs and intended uses is obtained by comparing actual system performance to pre-determined requirements.

Validation, in the context of government regulation, is distinct from hardware Installation Qualification/Operational Qualification/Instrument Performance Verification (IQ/OQ/IPV).

The purpose of the validation project is to document that the decisions made regarding the system have been properly designed, documented, executed, and verified. It is important to demonstrate that actions were properly planned, that the actions were executed according to the plan, and that the correct records have been kept.

The purpose of this white paper is to assist users in validating their Analyst® Software.

Further Information

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