Knowledgebase: Installation Qualification and Operational Qualification

De Novo Software is proud to offer a Customer Installation Qualification and Operational Qualification Program.

What does Installation Qualification (IQ) mean?

The IQ verifies that FCS Express was installed and configured according to specification. This includes:

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

What does Operational Qualification (OQ) mean?

The OQ establishes confidence that FCS Express and its features are capable of consistently operating as expected. OQ is a collection of functionality challenges that verify the proper functioning of a system.

Our OQ allows our customers to confirm and document proper FCS Express operation:

  • from examining that displays and menu functionality are correct,
  • to confirming correct mathematical functionality,
  • to verification 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.

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 IQOQ program offered by De Novo Software helps provide documented evidence that FCS Express is functioning within its specifications.

What is the pricing for the IQ/OQ program?

If you are interested in a quote, please email us at

Do you offer a sample of what the IQ/OQ covers?

If you are interested in obtaining a sample of our IQOQ, please email us at

If you have further questions that are not covered here, please email us at