FCS Express 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 labs needing to, or considering GxP compliancy (including 21 CFR part 11). Provided with out of the box and integrated features to meet requirements around security, audit trails, 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.
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.
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.
