Quality for Regulated Environments

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Following Good Laboratory Practice (GLP) is essential in regulated environments and your software used for 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 21 part 11 CFR compliance.

FCS Express is designed to help provide uniformity and consistency for 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.

 

21 Part 11 Compliance with Security and Logging

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FCS Express offers you the most complete set of 21 CFR Part 11 compliance tools to meet the needs of your regulated life-science laboratory including security, access limitations, authority checks, record protection, audit trails, electronic signatures, and much more.

All aspects of your analysis can be defined with restrictions at the user or analysis template based level to ensure compliance at every step in the analysis workflow. Users are challenged with authentication prompts and may electronically sign analysis templates as needed. Coupled with full audit trails to record every action performed, FCS Express will help enable compliance while still offering flexibility and unparalleled ease of use.  

Compare Across Samples with Ease

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FCS Express provides integrated tools to help compare between samples within your regulated environment. With FCS Express there is no need to copy and paste into multiple programs to get the job done and potentially leaving your secure environment. FCS Express offers integrated spreadsheets that allow you to create Bar Charts, Pie Charts, Regression Analysis, and Trend Lines along with just about every formula function offered by Excel. Additionally as you change data files or adjust gates, results will update immediately.

Installation Qualification and Operational Qualification

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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 the specification and to establish confidence that FCS Express and its features are capable of consistently operating as expected. Our IQ/OQ program will help

  • Verify that the proper files were installed correctly
  • Ensure the system hardware meets the demands of the software
  • Check that hardware and software configurations are correct, such that the application will reliably operate
  • Assist in examining that displays and menu functionality are correct
  • Confirm correct mathematical functionality
  • Verify that security features function as expected and in compliance with applicable regulations

Our OQ also allows you to document and justify any deviations to OQ instructions and specifications.

Data Integration and Integrity

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In many regulated environments 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, 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. FCS Express allows labs of any size to automatically export information directly to these systems rather than manually typing values to help reduce costly clerical errors while saving time and valuable resources. 

Join the Industry Leaders

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Lab work done in a validated environment requires structure and consistency, which means the tools that you use must be tried-and-true.   You already know that the best way to determine a proven method is to seek out the reviews of your peers.  Ask them and find out why so many GLP focused labs choose FCS Express.

De Novo Software is the industry leader in providing flow cytometry data analysis solutions in the clinical setting which has translated to trust and acceptance for labs following good lab practices.  Hundreds of clinical labs use FCS Express to analyze thousands of patient cases every day, year by year.  Doesn’t your data deserve the same kind of quality?

Testimonials

"FCS Express has revolutionized the way we think about data analysis. Not only are ALL the analysis tools available at your fingertips, the ability to work in a “Microsoft-like” environment makes the whole process intuitive and a great time savings. Our users have shared the same level of enthusiasm about our decision to switch to FCS Express for all our data analysis needs.”

Joanne Lannigan Ph.D.
Director, Flow Cytometry Core
University of Virginia 
School of Medicine

"FCS Express is the most intuitive, flexible, and comprehensive flow cytometry software we have ever used. The company is extremely responsive and supportive with helping us to accomplish very complex analyses and make sure the software is meeting our clinical laboratory needs. We have gone through several instrument and LIS transitions over the past 10 years and have been able to rely on the software to help alleviate the pain of those changes. We would highly recommend this for any flow lab!"

Carrie Gifford
Business Manager, Cancer & Blood Diseases Institute
Clinical Laboratories

"We have been offering FCS Express to our shared resource lab users since 2017. Thanks to the excellent support provided by De Novo Software, we have had a steady increase in users adopting this platform. De Novo Software is ready with classes, phone and online support and fits in well with the research services environment. Our users particularly like the user friendly interface!"

Jonni S. Moore Ph.D.
Professor and Faculty Director
Abramson Cancer Center Flow Cytometry and Cell Sorting Shared Resource
Perelman School of Medicine at University of Pennsylvania

 

“FCS Express from De Novo Software is an excellent software suite to facilitate researchers in their varying experimental complexities for flow and image cytometry.  The functionality and stability of the software combined with excellent and timely support has made it an important tool for research cytometry at TSRI"

Alan Saluk
Sr Scientific Director, Flow Cytometry
The Scripps Research Institute

 

"The customer service, and the functionality of the software is by far the best I’ve seen. Unless forced to, I will never touch FlowJo again"

-Anonymous

"You guys have the best customer service of ANY product I own."

David Grier

Wake Forest School of Medicine

"My users love the interface of FCS Express and find it quick and easy to learn. We love the speed and flexibility with data analysis. As a core manager, I appreciate the support the FCS Express team provides; they are always available to help my users." 

Vanessa Scarfone
Flow Cytometry Core Manager
Stem Cell Research Center
University of California Irvine

"Our group uses a wide variety of software for data analysis and processing. We are committed to using FCS express for our flow cytometry data needs as it is the most intuitive and flexible software available. The ease in interfacing with other Windows-based software and a convenient multiuser network installations were major determinants in our decision to purchase FCS Express. My staff enjoys being able to log in and process data from any desktop computing system in our facility. Application support and accessibility to a network of FCS Express users has also been very useful in developing batch processing and production protocols. Overall, I have not experienced the ease of use and broad applicability with other flow software product."

David DiGiusto, PhD

"I have found the online support material has been really helpful to my students to extend their knowledge independently."

Terry Pinfold

Cytometry and Histology Lab Manager, University of Tasmania

"I can't say enough good things about the program and the people who work on it."

Lisa Kohli
Laboratory Technician

"My function here at Integrated Oncology is to set up a work flow process for over 350 cases a day companywide so without a doubt I am choosing FCS Express to accomplish this. In my opinion there just isn't another software option for us. I need a user friendly package that will accommodate our current complex multicolor analysis as well as be able to expand for future growth, provide high quality reports for our clients, offer a virtual component for those customers that want to offer tech only flow or more closely interact with their patient results and the big challenge is that this has to happen in an extremely high volume reference laboratory. De Novo Software has been able to provide us with the features that we need and their technical support is extraordinary. I can't imagine a successful clinical lab without FCS Express; it is the "go-to" Clinical package."

Horacio Vall CLS, SCYM(ASCP)
Vice-President Science & Technology
Doctor of Biochemistry
Flow Cytometry Discipline Director Laboratory Corporation of America Holdings

"A major decision in our choice of software packages was dictated by how well we thought it would integrate with our report writing software (MS Word.) It is my impression that FCS Express does a better job with interfacing with other widely used software programs than the two other programs that we evaluated. It is hard to put into words, but FCS Express also seemed to have the look and feel of what I thought a "clinical" software program should be. Currently we spend excessive time in clerical tasks of transferring numerical values into our reports. In comparison with the other programs we reviewed, FCS Express seems to better suited to handle these repetitious tasks that are a big part of our clinical work and help separate this application from the needs of a "research" user. In short, the "automation" features of FCS Express seem stronger which are important to our clinical laboratory. Currently there is a labor tight market for qualified personnel in our area and we find it hard to attract technicians. Moreover it often takes years to fully train a technician. By using FCS Express anticipate shortening the training cycle by allowing our technicians more time to focus on the more demanding tasks in flow cytometry and less on clerical busy work. We are currently using DiVa, which is a great data acquisition program, but it does have serious limitations when used for routine data analysis and report generation thus leading to our decision to purchase FCS Express."

Nick Gonchoroff
Retired Associate Professor
Suny-Upstate Medical University

"The Hematopathology laboratory of the Shands Hospital at the University of Florida analyzes numerous bone marrow, blood and lymphoid tissue samples for the diagnosis of leukemia, lymphoma and related neoplastic conditions every day. We have been using BD's software for our data acquisition and analysis for many years. While adequate for acquisition, this software has several limitations regarding data analysis that recently prompted us to look for alternative programs for our clinical analytical work.   De Novo Software has provided an analysis tool that is completely optimized for clinical laboratories like ours. Within a short period of time, we created a drastically improved analysis protocol in FCS Express and it seems that every day we discover new features, such as tokens, alerts, panels, etc. that easily allow us to improve the quality of the analysis. Above all, I am extremely impressed with the excellence of the support staff that is always available to answer questions and courteously and positively responds to suggestions. In my opinion, FCS Express is one of the best programs available today for clinical flow cytometry laboratories."

Raul Braylan
Former Medical Director, Flow Cytometry Laboratory of the Shands Teaching Hospital at the University of Florida 

"I used to be in flowjo camp but I'm now totally converted to FCS express camp! Loving your software"

-Anonymous

"I am reaching out to let you know that V7 has been a great experience. My analysis time has been chopped by more than 50%. All the new features, etc, are great!"

Alberto Robert
Genetech