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Researchers Develop Software That Could Facilitate Drug Development
AptaTRACE can identify aptamers, potentially speed drug advancement.
Protein Nanocages Could Improve Drug Design and Delivery
HHMI scientists have designed and built 10 large protein icosahedra that are similar to viral capsids that carry viral DNA.
Connectome Map More Than Doubles Human Cortex’s Known Regions
Researchers at NIH have developed software that automatically detects the “fingerprint” of each of these areas in an individual’s brain scans.
Virus Inspired Cell Cargo Ships
Virus-inspired container design may lead to cell cargo ships following construction of ten large, two-component, icosahedral protein complexes.
Three-Drug Combinations Counter Antibiotic Resistance
Research shows that combinations of three different antibiotics can treat resistant bacteria, even if they are ineffective independently.
Supercomputing and Drug Discovery
New biotech company uses supercomputer simulations to speed up drug discovery and biotech molecule development.
Identifying Cancer Drug Targets Using 3D-Modelling
Researchers are now able to model genetic mutations manipulation of proteins that can potentially drive cancer.
Human Evolution Driven by Viruses
Study finds surprising percentage of protein adaptions in humans have been driven by viruses.
Earliest Sign of Alzheimer's Development Discovered
Researchers have identified the first physiological signs of late-onset Alzheimer's disease, underlining the importance of computational power in neurology.
Computational Method Offers Significant Boost in Finding New Cancer Targets
MIT and ARIAD Pharmaceuticals team have identified evidence of significant cancer mutations.
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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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