EZValidation Online Tool. The easy way to apply guidelines. The EZValidation Online Tool. The implementation of new tests



Similar documents
WinKQCL 5 Endotoxin Detection and Analysis Software We Analyze Endotoxin Data Every Day

The GeneAmp PCR System Results you can trust. A PCR platform you can grow with. GeneAmp. PCR System 9700

Cliquid ChemoView 3.0 Software Simple automated analysis, from sample to report

Quantifiler Human DNA Quantification Kit Quantifiler Y Human Male DNA Quantification Kit

Picis Anesthesia. Completely Integrated Anesthesia Management System

Automated Lab Management for Illumina SeqLab

Real-time PCR: Understanding C t

Financial Management TRANSACTION CONTROL AND APPROVAL

TruSeq Custom Amplicon v1.5

Optum Anesthesia. Completely integrated anesthesia information management system

Welcome to the fully integrated autoimmune laboratory. Saves time by reducing hands-on functions NOVA Lite Barcoded IFA Slides

Research Coordinator - PI s who have research coordinators or secretarial support can designate individuals to manage their IRB protocols in Mentor.

TaqMan Genotyper Software v1.0.1 TaqMan Genotyping Data Analysis Software

TotalChrom. Chromatography Data Systems. Streamlining your laboratory workflow

TargetQuan 3 Software. Leading the way in regulatory. POPs quantification. Bullet Bullet Bullet

Best Practices for Maintaining Quality in Molecular Diagnostics Gyorgy Abel, MD, PhD

OpenArray Sample Tracker Software

Clinical trial for 510(k) clearance

Data Analysis on the ABI PRISM 7700 Sequence Detection System: Setting Baselines and Thresholds. Overview. Data Analysis Tutorial

Document Change Control

SeqScape Software Version 2.5 Comprehensive Analysis Solution for Resequencing Applications

MultiQuant Software 2.0 for Targeted Protein / Peptide Quantification

Vmax Vyntus SPIRO. Advance your lung function testing experience

What is PDF Share Forms? PDF Share Forms is a web-based solution for PDF forms integration with SharePoint

Real-Time PCR Vs. Traditional PCR

Validating Methods using Waters Empower TM 2 Method. Validation. Manager

Infopoint Financial Control System (FCS)

NETWRIX EVENT LOG MANAGER

Document Control Management System

ComplianceSP TM on SharePoint. Complete Document & Process Management for Life Sciences on SharePoint 2010 & 2013

2.500 Threshold e Threshold. Exponential phase. Cycle Number

Optimizing Automation of Internal Controls for GRC and General Business Process Compliance

QA Software. a new way to view qa. Centralized, cloud-based data for easy management of TG-142 reporting. QA Pilot

LanguageDesk is the web-based project management tool from Milengo that takes the hassle out of managing translation projects.

Unique Software Tools to Enable Quick Screening and Identification of Residues and Contaminants in Food Samples using Accurate Mass LC-MS/MS

Put all your results in one basket. Orchard Pathology simplifies the complexities of clinical, molecular, and pathology testing and reporting.

SERVICE PLANS. More Productivity. Less Worry. SERVICE PLANS

Document Control for Control Freaks. Kristina Martin, MLS(ASCP) CM,MS

Institutional Partnership Program

CentraLink Data Management System

User Guide Package Exception Management

MET/TEAM Test Equipment Asset Management Software

LogInspect 5 Product Features Robust. Dynamic. Unparalleled.

Automated Library Preparation for Next-Generation Sequencing

Business Online Banking User Guide

LogPoint 5.1 Product Features Robust. Dynamic. Unparalleled.

QuantStudio 12K Flex Real-Time PCR System. The all-in-one qpcr instrument

Thermo Scientific ClinQuan MD Software For In Vitro Diagnostic Use. Confidence in Results With Data Integrity

SAP SuccessFactors Onboarding Technical and Functional Specifications

The Pension Portal. Helping you take your pension business into the paperless age

Laboratory Director Responsibilities

Major Process Future State Process Gap Technology Gap

MATCH IT! Antibody Software Quick Reference Guide

Our solutions reduce costs, streamline process and increase efficiencies. Facilities Management Litigation and Document Solutions

8 Key Requirements of an IT Governance, Risk and Compliance Solution

Bio-Rad Laboratories. QC data management solutions. Introduce Your Laboratory to a Whole New World of Unity Data Management Solutions

How To Create A Help Desk For A System Center System Manager

Residential Lending and Asset Management Solution for Investor-Owned Properties

Deploying the Workspace Application for Microsoft SharePoint Online

Adding Clinical Services to a Research Core Lab at the UW-Madison. Josh Hyman, Director UWBC DNA Sequencing Facility

our group Mission Overview Offering

GeneMapper ID-X Software Version 1.0

User Bulletin. GeneMapper Software Version 4.0. Installation Options. In This User Bulletin. Overview

billingplatform.com Case Study for Bizcel do Brazil Enterprise Billing for Cellular Providers

Adding Management.

Estimating and Vendor Quotes An Estimating and Vendor Quote Workflow Guide

Volunteer Software Feature Comparison

THE PREMIER INTEGRATED IT SERVICE MANAGEMENT TOOL

SUBJECT: New Features in Version 5.3

e-solutions by Thermo Fisher Scientific

QuantStudio 3D AnalysisSuite Software

Automating Anesthesia at Meditech Hospitals: Removing the Risk

Centricity Enterprise Provider Tools

ClinPlus. Clinical Trial Management System (CTMS) Technology Consulting Outsourcing. Expedite trial design and study set-up

BD Affirm VPIII. Microbial Identification System

Hematology, Chemistry, Microbiology. Clinical Pathology and Anatomic Pathology. Hospital Information System or Practice Management System

Resource Management for the Oil and Gas Industry

MATCH IT! DNA Software Quick Reference Guide

User Guide for the 21 CFR Part 11 Module in SDS Software v1.4

Protect the Past, Secure the Future

MRMPilot Software: Accelerating MRM Assay Development for Targeted Quantitative Proteomics

Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services

FCAP Array v3.0 Software: A New Tool to Analyze BD Cytometric Bead Array (CBA) Data. Monisha Sundarrajan, PhD BD Biosciences

LabChip GX/GXII with LabChip GxP Software

MOVING THE CLINICAL ANALYTICAL ENVIRONMENT INTO THE CLOUD

Power Up Your Business

End-to-End E-Clinical Coverage with Oracle Health Sciences InForm GTM

Craig Hallum Conference Investor Presentation

CONTRACTORS: GL RATER TRAINING GUIDE

History of Innovation

B i o s o l u t i o n s

Software Getting Started Guide

DRIVING SUCCESS 8 BEST PRACTICES FOR EASY EMPLOYEE EXPENSE TRACKING

Well known electronics and manufacturing company based in Manchester, UK.

HISTO SPOT SSO System. The most convenient automated HLA typing system. BAG Health Care the experts for HLA and blood group diagnostics

Improve your equity research productivity

Realistic? Content management initiatives can be a huge investment of time, money, and resources.

Quality Assurance for the Clinical Laboratory

Application Note # LCMS-62 Walk-Up Ion Trap Mass Spectrometer System in a Multi-User Environment Using Compass OpenAccess Software

Smart. Scalable. Simple.

Transcription:

The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically for assisting in the materials with the very best support possible to our guidelines established by governmental agencies or validation and verification of molecular tests. It provides molecular diagnostics customers. AcroMetrix became international institutions. The interpretation of guidelines, standard guideline choices for the laboratory to follow, part of Life Technologies in 200 and is organized under especially in regards to new testing techniques such as calculates the number of reactions and quality control the Applied Biosystems family of products. molecular diagnostic methods, can be very challenging. materials required, and applies statistical analysis Access to standardized protocols that meet or exceed to generate a final report to support user validation regulations, coupled with the appropriate control materials and verification of molecular tests. Contact your local and software solutions to aid in data analysis, is what sales representative or perform a free test drive of our laboratory managers look for. online tool. Over the coming months, you will notice changes to the AcroMetrix website and product packaging as we migrate to the Applied Biosystems brand. We re confident that this rebranding process will not only help us to continue to grow as a company, but that it will enable us to better assist you. For more information, please go to http://labqc.appliedbiosystems.com EZValidation Online Tool The EZValidation Online Tool is a tool intended to assist laboratories in meeting their verification and validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements. 200 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO5829 0 AcroMetrix by Life Technologies 600 Egret Ct. Benicia, CA 9450 USA Phone 707 746 8888 Toll Free 888 746 792 www.acrometrix.com International Sales For our office locations please call the division headquarters or refer to our website at http://www.lifetechnologies.com/about-life-technologies/contact-us.html The easy way to apply guidelines

The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically for assisting in the materials with the very best support possible to our guidelines established by governmental agencies or validation and verification of molecular tests. It provides molecular diagnostics customers. AcroMetrix became international institutions. The interpretation of guidelines, standard guideline choices for the laboratory to follow, part of Life Technologies in 200 and is organized under especially in regards to new testing techniques such as calculates the number of reactions and quality control the Applied Biosystems family of products. molecular diagnostic methods, can be very challenging. materials required, and applies statistical analysis Access to standardized protocols that meet or exceed to generate a final report to support user validation regulations, coupled with the appropriate control materials and verification of molecular tests. Contact your local and software solutions to aid in data analysis, is what sales representative or perform a free test drive of our laboratory managers look for. online tool. Over the coming months, you will notice changes to the AcroMetrix website and product packaging as we migrate to the Applied Biosystems brand. We re confident that this rebranding process will not only help us to continue to grow as a company, but that it will enable us to better assist you. For more information, please go to http://labqc.appliedbiosystems.com EZValidation Online Tool The EZValidation Online Tool is a tool intended to assist laboratories in meeting their verification and validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements. 200 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO5829 0 AcroMetrix by Life Technologies 600 Egret Ct. Benicia, CA 9450 USA Phone 707 746 8888 Toll Free 888 746 792 www.acrometrix.com International Sales For our office locations please call the division headquarters or refer to our website at http://www.lifetechnologies.com/about-life-technologies/contact-us.html The easy way to apply guidelines

How much time does validation of a molecular test take? It typically takes 58 working days, on average, to perform validation or verification of a molecular test, according to a recent survey of US laboratory managers and supervisors performing molecular testing. Some of the challenges reported were: The EZValidation Online Tool is designed specifically for Difficulty in determining the requirements necessary for a validation study Relying on software used in other laboratories that does not account for molecular methods Creating statistical analyses in Excel spreadsheets Keeping organized when working with multiple people on a validation The EZValidation Online Tool is the first to provide these molecular assay validation and verification features: Standard and customizable protocol options for the laboratory to follow Automatic calculation of the number of reactions and quality materials required Customizable plate mapping based upon your amplification detection system The ability to upload data for automated statistical analysis Validation or verification protocol and final report for printing or storage as a PDF file molecular diagnostic laboratories performing quantitative validation or verification studies. Days to Perform Molecular Validation Steps 30 Take a free test drive In 4 easy steps, the EZValidation Online Tool will calculate the number of reactions, panels, and standards needed. Visit our site at http://labqc.appliedbiosystems.com for a free test drive! 27 25 20 Identify guideline (ISO, CLIA, or custom) 8 5 3 Enter lab and assay info, calculate reagent needs Set up other users, create and print plate maps Enter and review data Generate reports Figure 3. Drop-down driven choices of packaged assays to choose from. Figure 4. A choice of ISO 589 or CAP/CLIA/NY State guidelines and the list of protocols which can be chosen or de-selected. Figure 5. Confirmation of your instruments, list of controls, and extraction volume needed. Figure 6. Easy-to-read order summary containing the number of total reactions and the standards and controls needed for your validation or verification. Options to save your study (if you log in) and request a quote are provided. Figure 2. Typical molecular assay validation workflow. 0 5 0 Research Guidelines and Create Protocols Set up Statistical Analysis and Create the Final Validation/ Templates Verification Report Figure. Typical number of working days required to perform different steps during the validation of a molecular test (excluding time to execute protocols). With the EZValidation Online Tool, you have a convenient, intuitive application to guide you through: Translating regulatory guidelines into user-defined validation or verification prot ocols Calculating the amount of reagents and quality materials needed to run the protocol Consolidating studies (i.e., accuracy, precision, LOD) across runs and days to minimize time and reagents Selecting and performing statistical analyses Combining results and data analysis into a single validation report for signature Source: Molecular verification and validation survey of US laboratory managers and supervisors. Performed September 200. Standard guideline choices are just the beginning AcroMetrix is focused on quality control products, services, and systems for molecular diagnostics. The EZValidation Online Tool offers a choice of protocols based on ISO 589 or CAP/CLIA/New York State validation and verification guidelines for setting up your studies. In addition, we ve designed the online tool so that you can create your own protocols. Keep up with changing guidelines As a leader in molecular quality materials, AcroMetrix closely monitors changing requirements for clinical laboratories as new standards emerge. Because the EZValidation Online Tool is webbased, you have access to new protocols as guidelines change. Designed for AcroMetrix, but compatible with any While we encourage the use of AcroMetrix quality materials for your validations and verifications, we realize your need for flexibility to accommodate new tests. The EZValidation Online Tool is designed for use with or without AcroMetrix quality control materials. Year subscriptions or pay per use are available. Inquire with your local sales representative for more information.

How much time does validation of a molecular test take? It typically takes 58 working days, on average, to perform validation or verification of a molecular test, according to a recent survey of US laboratory managers and supervisors performing molecular testing. Some of the challenges reported were: The EZValidation Online Tool is designed specifically for Difficulty in determining the requirements necessary for a validation study Relying on software used in other laboratories that does not account for molecular methods Creating statistical analyses in Excel spreadsheets Keeping organized when working with multiple people on a validation The EZValidation Online Tool is the first to provide these molecular assay validation and verification features: Standard and customizable protocol options for the laboratory to follow Automatic calculation of the number of reactions and quality materials required Customizable plate mapping based upon your amplification detection system The ability to upload data for automated statistical analysis Validation or verification protocol and final report for printing or storage as a PDF file molecular diagnostic laboratories performing quantitative validation or verification studies. Days to Perform Molecular Validation Steps 30 Take a free test drive In 4 easy steps, the EZValidation Online Tool will calculate the number of reactions, panels, and standards needed. Visit our site at http://labqc.appliedbiosystems.com for a free test drive! 27 25 20 Identify guideline (ISO, CLIA, or custom) 8 5 3 Enter lab and assay info, calculate reagent needs Set up other users, create and print plate maps Enter and review data Generate reports Figure 3. Drop-down driven choices of packaged assays to choose from. Figure 4. A choice of ISO 589 or CAP/CLIA/NY State guidelines and the list of protocols which can be chosen or de-selected. Figure 5. Confirmation of your instruments, list of controls, and extraction volume needed. Figure 6. Easy-to-read order summary containing the number of total reactions and the standards and controls needed for your validation or verification. Options to save your study (if you log in) and request a quote are provided. Figure 2. Typical molecular assay validation workflow. 0 5 0 Research Guidelines and Create Protocols Set up Statistical Analysis and Create the Final Validation/ Templates Verification Report Figure. Typical number of working days required to perform different steps during the validation of a molecular test (excluding time to execute protocols). With the EZValidation Online Tool, you have a convenient, intuitive application to guide you through: Translating regulatory guidelines into user-defined validation or verification prot ocols Calculating the amount of reagents and quality materials needed to run the protocol Consolidating studies (i.e., accuracy, precision, LOD) across runs and days to minimize time and reagents Selecting and performing statistical analyses Combining results and data analysis into a single validation report for signature Source: Molecular verification and validation survey of US laboratory managers and supervisors. Performed September 200. Standard guideline choices are just the beginning AcroMetrix is focused on quality control products, services, and systems for molecular diagnostics. The EZValidation Online Tool offers a choice of protocols based on ISO 589 or CAP/CLIA/New York State validation and verification guidelines for setting up your studies. In addition, we ve designed the online tool so that you can create your own protocols. Keep up with changing guidelines As a leader in molecular quality materials, AcroMetrix closely monitors changing requirements for clinical laboratories as new standards emerge. Because the EZValidation Online Tool is webbased, you have access to new protocols as guidelines change. Designed for AcroMetrix, but compatible with any While we encourage the use of AcroMetrix quality materials for your validations and verifications, we realize your need for flexibility to accommodate new tests. The EZValidation Online Tool is designed for use with or without AcroMetrix quality control materials. Year subscriptions or pay per use are available. Inquire with your local sales representative for more information.

How much time does validation of a molecular test take? It typically takes 58 working days, on average, to perform validation or verification of a molecular test, according to a recent survey of US laboratory managers and supervisors performing molecular testing. Some of the challenges reported were: The EZValidation Online Tool is designed specifically for Difficulty in determining the requirements necessary for a validation study Relying on software used in other laboratories that does not account for molecular methods Creating statistical analyses in Excel spreadsheets Keeping organized when working with multiple people on a validation The EZValidation Online Tool is the first to provide these molecular assay validation and verification features: Standard and customizable protocol options for the laboratory to follow Automatic calculation of the number of reactions and quality materials required Customizable plate mapping based upon your amplification detection system The ability to upload data for automated statistical analysis Validation or verification protocol and final report for printing or storage as a PDF file molecular diagnostic laboratories performing quantitative validation or verification studies. Days to Perform Molecular Validation Steps 30 Take a free test drive In 4 easy steps, the EZValidation Online Tool will calculate the number of reactions, panels, and standards needed. Visit our site at http://labqc.appliedbiosystems.com for a free test drive! 27 25 20 Identify guideline (ISO, CLIA, or custom) 8 5 3 Enter lab and assay info, calculate reagent needs Set up other users, create and print plate maps Enter and review data Generate reports Figure 3. Drop-down driven choices of packaged assays to choose from. Figure 4. A choice of ISO 589 or CAP/CLIA/NY State guidelines and the list of protocols which can be chosen or de-selected. Figure 5. Confirmation of your instruments, list of controls, and extraction volume needed. Figure 6. Easy-to-read order summary containing the number of total reactions and the standards and controls needed for your validation or verification. Options to save your study (if you log in) and request a quote are provided. Figure 2. Typical molecular assay validation workflow. 0 5 0 Research Guidelines and Create Protocols Set up Statistical Analysis and Create the Final Validation/ Templates Verification Report Figure. Typical number of working days required to perform different steps during the validation of a molecular test (excluding time to execute protocols). With the EZValidation Online Tool, you have a convenient, intuitive application to guide you through: Translating regulatory guidelines into user-defined validation or verification prot ocols Calculating the amount of reagents and quality materials needed to run the protocol Consolidating studies (i.e., accuracy, precision, LOD) across runs and days to minimize time and reagents Selecting and performing statistical analyses Combining results and data analysis into a single validation report for signature Source: Molecular verification and validation survey of US laboratory managers and supervisors. Performed September 200. Standard guideline choices are just the beginning AcroMetrix is focused on quality control products, services, and systems for molecular diagnostics. The EZValidation Online Tool offers a choice of protocols based on ISO 589 or CAP/CLIA/New York State validation and verification guidelines for setting up your studies. In addition, we ve designed the online tool so that you can create your own protocols. Keep up with changing guidelines As a leader in molecular quality materials, AcroMetrix closely monitors changing requirements for clinical laboratories as new standards emerge. Because the EZValidation Online Tool is webbased, you have access to new protocols as guidelines change. Designed for AcroMetrix, but compatible with any While we encourage the use of AcroMetrix quality materials for your validations and verifications, we realize your need for flexibility to accommodate new tests. The EZValidation Online Tool is designed for use with or without AcroMetrix quality control materials. Year subscriptions or pay per use are available. Inquire with your local sales representative for more information.

The implementation of new tests The EZValidation Online Tool Since 999, AcroMetrix has provided quality control requires validation or verification studies that meet is a comprehensive tool specifically for assisting in the materials with the very best support possible to our guidelines established by governmental agencies or validation and verification of molecular tests. It provides molecular diagnostics customers. AcroMetrix became international institutions. The interpretation of guidelines, standard guideline choices for the laboratory to follow, part of Life Technologies in 200 and is organized under especially in regards to new testing techniques such as calculates the number of reactions and quality control the Applied Biosystems family of products. molecular diagnostic methods, can be very challenging. materials required, and applies statistical analysis Access to standardized protocols that meet or exceed to generate a final report to support user validation regulations, coupled with the appropriate control materials and verification of molecular tests. Contact your local and software solutions to aid in data analysis, is what sales representative or perform a free test drive of our laboratory managers look for. online tool. Over the coming months, you will notice changes to the AcroMetrix website and product packaging as we migrate to the Applied Biosystems brand. We re confident that this rebranding process will not only help us to continue to grow as a company, but that it will enable us to better assist you. For more information, please go to http://labqc.appliedbiosystems.com EZValidation Online Tool The EZValidation Online Tool is a tool intended to assist laboratories in meeting their verification and validation requirements. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements. 200 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO5829 0 AcroMetrix by Life Technologies 600 Egret Ct. Benicia, CA 9450 USA Phone 707 746 8888 Toll Free 888 746 792 www.acrometrix.com International Sales For our office locations please call the division headquarters or refer to our website at http://www.lifetechnologies.com/about-life-technologies/contact-us.html The easy way to apply guidelines