Validation Ready Package

The new FCS Express^™ Validation Ready package is designed for researchers in the Cell and Gene Therapy (CGT) space, those currently operating in regulated environments, and any lab with a need for GxP compliancy (including 21 CFR part 11). It provides out of the box and integrated features designed to meet requirements around security, audit trails, and e-signatures so your regulatory and Computer System Validation (CSV) requirements are met in a cohesive way and don’t rely on costly and inefficient workarounds.

We are certified to ISO 13485:2016 (certified by NQA) and to ISO/IEC 27001:2022 (certified by Shellman), demonstrating our commitment to quality and information security. These reflect independently audited systems that help ensure consistent, reliable delivery, and secure handling of customer data.

Out of the box features provided

Self-hosted Network license
Definable security groups/permissions
Electronic signatures
Step by step audit trails during analysis
System level audit trails

Additional available features for purchase

LDAP/Single Sign On
LIS/LIMS Integration
IQOQ Validation
Customized training and support

Easy and Scalable Pricing

Validation Ready Base Package supporting 2 concurrent users

Research Use Only (RUO) Edition $4,830* | Clinical Edition $6,460*

Scalable licensing to fit your lab’s current and future needs

(*for “non-commercial” use – contact us for more information)

Why should you use FCS Express^™ software within your new or existing GxP processes?

FCS Express^™ can be easily integrated into existing or new Flow Cytometry workflows to support your validation needs.
Software validation leads to reliable and repeatable R&D.
Utilizing the validation ready features of FCS Express^™ helps to ensure that the software will always perform in a predictable and reliable manner, enabling data integrity, and traceability.
Scalability – easily bring on additional users or scale to other labs and manufacturing sites.

Why should you choose FCS Express^™ software when other tools are available, sometimes at a lower cost?

FCS Express^™‘s validation ready tools may help to significantly reduce resource and project costs associated with implementing competing packages in a GxP compliant environment.
Other vendors do not provide validation ready, out of the box tools which requires additional time, workarounds, additional SOP’s and possibly PQs to meet your regulatory needs. FCS Express^™ integrates the tools you need to prevent inefficiencies found in other software offerings.
Other software tools do not allow you to easily scale between basic R&D, validation, pre-clinical, and clinical environments in a consistent, controlled and documented manner.
FCS Express^™ layouts and panel features enable quick paired study runs and comparability less complexity and more efficiency.

Our team of experts are ready to help. With years of experience in the clinical, validated, and cytometry industry, we are uniquely suited to support your needs.

Key Features / Components

21 Part 11 Compliance with Security and Logging

FCS Express^™ offers you the most complete set of 21 CFR Part 11 compliance tools to meet the needs of your regulated life-science flow cytometry laboratory including security, access limitations, authority checks, record protection, audit trails, electronic signatures, and much more. Coupled with full system level audit trails to capture any changes, FCS Express will help and enable compliance while still offering flexibility and unparalleled ease of use.

Installation Qualification and Operational Qualification

De Novo Software is proud to offer a Customer Installation Qualification and Operational Qualification Program (IQ/OQ) to verify that FCS Express^™ was installed and configured according to specifications and to establish confidence that FCS Express^™ and its features are capable of consistently operating as expected. Our IQ/OQ will help verify that the proper files were installed correctly. In addition our OQ also allows you to document and justify any deviations to OQ instructions and specifications.

Data Integration and Integrity

In many regulated environments, flow cytometry data analysis needs to be integrated among different systems. FCS Express^™ offers a number of ways to interface with data in your regulated environment through simple direct exports to PDF, Excel, PowerPoint, GraphPad Prism, and Word. In addition FCS Express^™ can support direct integration with Lab Information Systems (LIS) or Lab Information Management Systems (LIMS) to consolidate and centralize information from many modalities.