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Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
A Diversity of Genomes
New DNA from understudied groups reveals modern genetic variation, ancient population shifts.
“Sixth Sense” May Be More Than Just A Feeling
The NIH Study shows that two young patients with a mutation in the PIEZ02 have problems with touch and proprioception, or body awareness.
Gene Could Reduce Female Mosquitoes
Virginia Tech researchers have found a gene that can reduce female mosquitoes over many generations.
Biomolecular Manufacturing ‘On-the-Go’
Wyss Institute team unveils a low-cost, portable method to manufacture biomolecules for a wide range of vaccines, other therapies as well as diagnostics.
Improving Crop Efficiency with CRISPR
New study of CRISPR-Cas9 technology from Virginia Tech shows potential to improve crop efficiency.
Fighting Cancer with Sticky Nanoparticles
Treatment that uses bioadhesive nanoparticles drug carriers proved more effective than conventional treatments for certain cancers.
Stem Cell ‘Heart Patch’ Almost Perfected
Scientists aiming to perfect and test 3D "heart patches" in animal model, last hurdle before human patients.
Fighting Plant Pathogens with RNA
Researchers develop strategy that could lead to environmentally friendly fungicide to fight pathogens.
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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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