Have confidence in your results

Installation Qualification and Operational Qualification

Creating and managing your own documentation to verify and validate your software can be time consuming and difficult. De Novo Software is proud to offer a Customer Installation Qualification and Operational Qualification (IQ/OQ) Program to ensure 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 also allows you to document and justify any deviations to IQ/OQ instructions and specifications.

Installation Qualification


Ensure that FCS Express is installed correctly and is performing to specification.

IQ verification checks:

  • That the proper files were installed correctly
  • That the system hardware meets the demands of the software
  • That hardware and software configurations are correct, such that the application will reliably operate
  • And much more...

Operational Qualification


Confirm and document proper operation of FCS Express via OQ to establish confidence. OQ includes:

  • Examining that displays and menu functionality are correct
  • Confirming correct mathematical functionality
  • Verification that security features function as expected and in compliance with applicable regulations
  • And much more...

Do I need to add Qualification to my current validation protocol?

The objective of validation is to produce documented evidence that provides a high level of assurance that all features of an automated system will work correctly and consistently. The IQ/OQ Program offered by De Novo Software helps provide the evidence that FCS Express is functioning within its specifications.

Get More Information

If you are interested in a quote, have questions, or if you are interested in obtaining a sample of our IQ/OQ Program please email us at sales@denovosoftware.com or fill out the form below.