Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>Resources>White Papers>This White Paper
  White Papers
Scientific News
Breakthrough Flu Vaccine Inhibited by Pre-existing Antibodies
Universal truths – how existing antibodies are sabotaging the most promising new human flu vaccines.
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
New Medication Shows Promise Against Liver Fibrosis in Animal Studies
Liver fibrosis is a gradual scarring of the liver that puts people at risk for progressive liver disease and liver failure.
Raw Eggs Deemed Safe to Eat
A report published today by the Advisory Committee on the Microbiological Safety of Food (ACMSF) into egg safety has shown a major reduction in the risk from salmonella in UK eggs.
Monitoring TTX Toxin in Shellfish
In a number of small studies, mussels and oysters from the eastern and northern part of the Oosterschelde in Holland were found to contain tetrodotoxin (TTX).
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Gene-Editing 'Toolbox' Targets Multiple Genes Simultaneously
Researchers have designed a system that modifies, or edits, multiple genes in a genome at once while minimising unintentional effects.
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
Antibody Drug Shows Promise in HIV Treatment
Researchers are a step closer to an alternative HIV treatment that has the potential for lasting effects and less frequent dosing.
Scroll Up
Scroll Down

Considerations When Validating Your Analyst® Software
Bookmark and Share


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

Related Content

SCIEX Works with the Francis Crick Institute and the University of Cambridge
New proteomic study to develop advanced resource for precision medicine research by using Microflow SWATH® Acquisition for HT industrialized proteomics.
Wednesday, June 29, 2016
Solutions for Biotherapeutic Characterization
Innovation to speed the routine.
Friday, June 17, 2016
SCIEX, QPS Holdings Collaborate
Agreement aims to advance the hybrid LBA-LCMS workflow for biologics quantification.
Wednesday, April 06, 2016
SCIEX, Children's Medical Research Institute Collaborate
SCIEX industrialized proteomics solutions, using SWATH® Acquisition-based workflows and powered by the OneOmics™ Project, will enable large scale proteome studies to advance cancer research.
Thursday, February 11, 2016
SCIEX, A*STAR’s BTI Launch Collaboration
Agreement aims to boost innovation of protein drugs that target new diseases and are safer for patients.
Wednesday, January 27, 2016
SCIEX, Pressure BioSciences Partner
SCIEX and Pressure BioSciences to offer complete solution for next-generation proteomics, to increase the reproducibility and depth of proteomic analysis.
Wednesday, January 13, 2016
SCIEX, University of Manchester Partner
SWATH® Acquisition-based next-generation proteomics technology promises to make industrial proteomics a reality.
Thursday, October 29, 2015
SCIEX Partners with the Paulovich Lab at Fred Hutchinson Cancer Research Center
Collaboration targets research reproducibility crisis with highly validated multiplex quantitation assays.
Wednesday, September 23, 2015
SCIEX and New Objective Announce Partnership
New nanospray sources to offer maximum sensitivity and robustness for NanoLC-MS.
Tuesday, June 02, 2015
SCIEX and New Objective Partner
Partnership will provide advanced nanospray ionization technologies for next-generation proteomics.
Tuesday, May 26, 2015
SCIEX and Hepregen Announce Co-Marketing Agreement
Alliance establishes SCIEX and Hepregen as a one-stop solution provider for drug metabolism investigators.
Friday, May 22, 2015
Sciex, Hepregen Team up on Metabolite Identification Offering
This recently announced collaboration aims to provide practical solutions for drug metabolism researchers.
Thursday, May 21, 2015
Dr. Gyula Vigh wins Arnold O. Beckman Award
SCIEX sponsored award recognizes outstanding contributions to the field of electrodriven separation techniques.
Thursday, May 07, 2015
SCIEX and Mass Consortium Corporation Announce Exclusive Reseller Agreement
SCIEX to provide customers with XCMSplus software solution for simplified and accelerated metabolomics workflows.
Tuesday, March 31, 2015
SCIEX Announces OneOmics™ Collaborators
Advaita Bioinformatics, Researchers at Yale University and ISB launch applications and libraries that combine next-generation proteomics and next-generation sequencing data in innovative ways.
Thursday, March 19, 2015
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!