Clinical and Regulated

SOPs based analysis

In This Video

Clinical labs performing diagnostic testing or labs functioning in 21 CFR Part 11 regulated environments need to ensure the quality of their flow cytometry results, but this can often be a tedious and time-consuming manual process. FCS Express 7 includes many tools to enhance, streamline, and automate quality checks throughout the entire process from analysis to report generation. This webinar will discuss how De Novo Software provides the quality assurance you need with our new ISO 13485:2016 and ISO/IEC 27001:2022 certifications. We will also present an overview of some of the readily available tools to help labs ensure reproducibility and quality results.

Learn How To

Verify the Proper Installation and Operation with IQ/OQ Validation
Use SOPs as Training and Competency Tools for Analysts
Incorporate Features of FCS Express for Quality Control

Focus on Quality Results with FCS Express 7 (Full video)

In This Video

Labs performing diagnostic or clinical flow assays need to ensure the quality of their patient results, but this can often be a tedious and time-consuming manual process. The Clinical Edition of FCS Express 7 includes many tools to enhance, streamline and automate quality checks throughout the entire process from analysis to report generation. This presentation provides an overview of some of the readily available tools to ensure reproducibility and quality results using FCS Express. We start off covering essential elements like tokens, alerts, statistical classifiers, authorization, and permission rules; build up to more complex examples of SOP controlled layouts, 21 CFR Part 11 features (security & logging), IQ/OQ validation procedures and finish with newer elements like integrated Levey Jennings plots.

Learn How To

Verify the Proper Installation and Operation with IQ/OQ Validation
Use SOPs as Training and Competency Tools for Analysts
Incorporate Features of FCS Express for Quality Control

Quality for regulated lab environments: Meeting CFR 21 Part 11 compliance with FCS Express

In This Video

Following Good Laboratory Practice (GLP) is essential in regulated environments and your software used for flow cytometry data analysis and reporting should not be an exception. FCS Express helps labs that need to ensure the quality and integrity of their analysis workflow by offering unique features made to satisfy CFR 21 Part 11 compliance, including security and logging/audit trails. FCS Express is designed to help provide uniformity and consistency for flow cytometry data analysis within your lab, across sites, and for your clients by working in a software environment where every action and permission can be controlled at the user and analysis template level. When reproducible results are key to your workflow for flow or image cytometry based analysis FCS Express should be your tool of choice. Make sure to watch this special webinar especially if you are working in GMP, Cell Therapy, and other lab environments where quality, consistency, and documentation is key.

Learn How To

Use FCS Express to Meet CFR 21 Part 11 Compliance
Access Logging/Audit Trails
Incorporate Security Features

21 CFR Part 11 Features

In This Video

View this webinar to learn all about the FCS Express Security System, with over 300 permissions, extensive reporting, electronic signatures, and more. FCS Express provides comprehensive functionality for your security and 21 CFR Part 11 requirements.

Learn How To

Establish User and Layout Security
Add and Insert Electronic Signatures
Review the Audit Trail

Visibility, Authorizations, and Locking in FCS Express 7

In This Video

Explore the Visibility, Authorization, and Locking capabilities in FCS Express 7. With Visibility, learn how to hide or show objects, gates, quadrants, and markers. Allow or deny access to certain features with Authorizations and Locking. Or use custom expressions to control these features conditionally based on token values. Watch this webinar and learn how to get the most out of Visibility, Authorization, and Locking in FCS Express!

Learn How To

Control Visibility of Objects, Plots, and/or Pages
Enable or Disable Select or Edit Authorizations
Lock Gates to Prevent Moving or Editing

FCS Express IVD

In This Video

You will learn about new features and capabilities in FCS Express Clinical Edition that will enhance your data analysis.

Learn How To

Export to an Integrated Spreadsheet within an FCS Express Layout
Enable FCS Express to Remember Manually Set Scaling
Implement System Level Audit Trails

Clinical Features of FCS Express

In This Video

In this presentation, we will provide an overview of some of the readily available tools to ensure reproducibility and quality results using FCS Express. We will start off covering basic elements like tokens, alerts, statistical classifiers, authorization and permission rules; build up to more complex examples of SOP controlled layouts, 21 CFR Part 11 features (security & logging), IQ/OQ validation procedures and finish with newer elements like integrated Levey Jennings plots.

Learn How To

Define Security Group Permissions
Set Permissions for a Specific Layout
Work with Electronic Signatures and Audit Trails

What’s new in FCS Express 7 IVD for Clinical and Validated Laboratories

In This Video

FCS Express 7.24.0024 is finally here and there are new enhancements for IVD! This webinar is specifically for clinical labs and anyone in a GxP/GmP validated space using FCS Express 7 IVD. We will show new features designed to help make your workflows easier and more efficient, including in-plot slider bars for axis scaling and a new Token Report tool. We will also provide overview of the new Quads as Gates feature and how to manage this change with your current layouts.

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