" "
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>Resources>White Papers>This White Paper
  White Papers
Scientific News
Food Triggers Creation of Regulatory T Cells
IBS researchers document how normal diet establishes immune tolerance conditions in the small intestine.
Light Signals from Living Cells
Fluorescent protein markers delivered under high pressure.
Counting Cancer-busting Oxygen Molecules
Researchers from the Centre for Nanoscale BioPhotonics (CNBP), an Australian Research Centre of Excellence, have shown that nanoparticles used in combination with X-rays, are a viable method for killing cancer cells deep within the living body.
Therapeutic Approach Gives Hope for Multiple Myeloma
A new therapeutic approach tested by a team from Maisonneuve-Rosemont Hospital (CIUSSS-EST, Montreal) and the University of Montreal gives promising results for the treatment of multiple myeloma, a cancer of the bone marrow currently considered incurable with conventional chemotherapy and for which the average life expectancy is about 6 or 7 years.
Cellular 'Relief Valve'
A team led by scientists at The Scripps Research Institute (TSRI) has solved a long-standing mystery in cell biology by showing essentially how a key “relief-valve” in cells does its job.
Genomic Signature Shared by Five Types of Cancer
National Institutes of Health researchers have identified a striking signature in tumor DNA that occurs in five different types of cancer.
Protein Protects Against Flu in Mice
The engineered molecule doesn’t provoke inflammation and may hail a new class of antivirals.
Cat Stem Cell Therapy Gives Humans Hope
By the time Bob the cat came to the UC Davis veterinary hospital, he had used up most of his nine lives.
Crowdfunding the Fight Against Cancer
From budding social causes to groundbreaking businesses to the next big band, crowdfunding has helped connect countless worthy projects with like-minded people willing to support their efforts, even in small ways. But could crowdfunding help fight cancer?
Switch Lets Salmonella Fight, Evade Immune System
Researchers at the University of Illinois at Chicago have discovered a molecular regulator that allows salmonella bacteria to switch from actively causing disease to lurking in a chronic but asymptomatic state called a biofilm.
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, 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
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
AB SCIEX Wins New Product Innovation Award in Asia Pacific
The award recognizes the company’s continued innovation in the mass spectrometry industry and a number of new products introduced into the market in recent years.
Thursday, October 30, 2014
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!