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Molecule Prevents Effect of Chemotherapy
Danish researchers from Aarhus University Hospital and Aarhus University have made a possible breakthrough in the treatment of colorectal cancer.
Peptide Mutants Help Identify Vulnerability in Tumor Cells
Researchers can detect mutant proteins based on MS data and the results of exome sequencing.
Misfiring Drugs Hit the Wrong Targets
Anti-HIV protein inhibitor drugs can bind to the wrong protein, causing unwanted side effects.
New Possibilities Tumor Research
Grazer researchers say gene activity of the tumor from the analysis of circulating DNA in blood ahead.
Parkinson’s Test Could Aid Early Detection
A test that can detect Parkinson’s disease in the early stages of the illness has moved a step closer.
Oxygen Can Impair Cancer Immunotherapy
Researchers have identified a mechanism within the lungs where anticancer immune resposnse is inhibited.
Symmetry is Key to Collagen
Researchers describe how symmetry may be the key to growing collagen fibres outside the body.
Breakthrough in GPCR Understanding
Integral Molecular announces breakthrough in understanding the functionality of GPCRs, the largest class of drug targets in human disease.
Designing Ultrasound Tools with Lego-Like Proteins
Study outlines how ultrasound technology can be used for imaging in conjuction with protein engineering.
Enzyme that Triggers Cell Demise in ALS Identified
Scientists from Harvard have identified a key instigator of nerve cell damage in people with amyotrophic lateral sclerosis (ALS).
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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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