Corporate Banner
Satellite Banner
Mass Spectrometry
Scientific Community
 
Become a Member | Sign in
Home>Resources>White Papers>This White Paper
  White Papers
Scientific News
Metabolite Promotes Cancer Cell Transformation
Researchers have identified a metabolite that promotes cancer cell transformation and colorectal cancer spread.
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
Hunting the Missing Link Between Genetics and the Environment
The International Phenome Centre Network (IPCN) works to transform healthcare through phenomics - the dynamic interactions between our genes and our environment.
Cocaine Test Could Lead to Rapid Roadside Testing
Scientists develop urine and oral fluid diagnostic test for cocaine, utilising a compact mass spectrometer.
The Benefits of a Mediterranean-style Diet
A Western-style diet, with more omega-6 fatty acids than the Mediterranean, dysregulates lipid signaling in aged mice and promotes inflammation.
Peer Review is in Crisis, But Should be Fixed, Not Abolished
After the time to get the science done, peer review has become the slowest step in the process of sharing studies, and some scientists have had enough.
Rapid Identification of Illicit Designer Drugs
New technique can identify commonly used illicit compounds in as little as 15 seconds.
Enhancing On-line Biological Sample Processing
New techniques are required to meet emerging demands on biopharmaceutical analysis.
Early Warning System for Colorectal Cancer
Potential new diagnostic tool identified for the second most common cancer in the world.
Scientists Develop a Novel Method to Benchmark and Improve the Performance of Protein Measurement Techniques
A wide range of laboratories around the world are benefiting from this work, which enables researchers to analyze or compare the results of quantitative proteomics assays in a standardized way.
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

Collaboration to Develop Cannabis Testing Standards
SCIEX workflow solution enables cannabis labs to ensure product safety with robust, cost-effective analytical methods to facilitate routine testing.
Tuesday, September 13, 2016
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
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 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 and Labor Berlin Collaboration to Advance Forensic Testing
Collaboration for the development of a hybrid Quadrupole Time-of-Flight (TOF) MS/MS reference library.
Thursday, March 05, 2015
New Capabilities for Bioanalysis Studies at the International Pharmaceutical Research Center
AB SCIEX Triple Quad™ 6500 LC/MS/MS systems enable new levels of sensitivity for clinical trials of inhaled drugs.
Wednesday, February 11, 2015
Improved Accuracy of Pesticide Detection in Food
European Reference Laboratory improves accuracy of pesticide detection in food with AB SCIEX mass spectrometry instrumentation.
Wednesday, February 04, 2015
SELECTBIO

SELECTBIO Market Reports
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
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!