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Antioxidants Cause Malignant Melanoma to Metastasize Faster
Fresh research at Sahlgrenska Academy has found that antioxidants can double the rate of melanoma metastasis in mice.
New Protein Cleanup Factors Found to Control Bacterial Growth
UMass Amherst researchers characterize previously mysterious proteolysis factors.
New Treatment for Obesity Developed
Researchers at the University of Liverpool, working with a global healthcare company, have helped develop a new treatment for obesity.
How Cell Growth Triggers Cell Division
Researchers in Jan Skotheim's lab have discovered a previously unknown mechanism that controls how large cells grow, an insight that could one day provide insight into attacking diseases such as cancer.
Metabolomic Platform Reveals Fundamental Flaw in Common Lab Technology
A new study led by scientists at The Scripps Research Institute (TSRI) shows that a technology used in thousands of laboratories, called gas chromatography mass spectrometry (GC-MS), fundamentally alters the samples it analyzes.
Newly Identified Biochemical Pathway Could Be Target for Insulin Control
Researchers at Duke Medicine and the University of Alberta are reporting the identification of a new biochemical pathway to control insulin secretion from islet beta cells in the pancreas, establishing a potential target for insulin control.
Dirty,Crusty Meals Fit for (Long-Dormant) Microbes
Researchers apply the latest analytical techniques to further our understanding of desert biocrusts.
CSI -- On The Metabolite's Trail
Bioinformaticians at the University of Jena make the most efficient search engine for molecular structures available online.
Developing a Breathalyzer-Type Low Blood Sugar Warning Device For Diabetes
A multidisciplinary team of researchers at Indiana University-Purdue University Indianapolis has been awarded a $738,000 National Science Foundation grant to develop a breathalyzer-type device to detect the onset of hypoglycemia, or low blood sugar episodes, in people with diabetes.
Identifying The 'Dimmer Switch' Of Diabetes
University of Alberta research gives new insight into what causes Type 2 diabetes.
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Considerations When Validating Your Analyst® Software
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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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