What are Qualification Protocols in Risk-Based Software Validation?
Part 5: What about Qualification Protocols and Execution?
The goal of software validation is to document that your system works as intended and having gone through the steps discussed in earlier blogs within this series, we can now develop and execute the necessary qualification protocols in risk-based software validation. There are two qualification protocols that you will need to complete the validation; and a third that can be completed either before or after your system is deployed in production. They are:
- The Installation Qualification (IQ)
- The Operational Qualification (OQ)
- The Performance Qualification (PQ)
These qualification protocols are used to ensure that all necessary tests and checks are performed to verify that the hardware, associated infrastructure, and software are in place and documented…as required by both your own internal standards, those of the software vendor and any regulatory body.
The Installation Qualification (IQ)
The IQ will focus on documenting the actual installation of the software, the capabilities of the hardware and the appropriateness of the supporting infrastructure and processes, such as networks and backups.
The Operational Qualification (OQ)
The OQ will focus on documenting the tests and expected results that will be used to verify that the system is working as you intended it to work, and that any mitigations that were put in place to reduce an identified risk are also working and effective. When the OQ is executed, the results of each test will be documented and any failures will be resolved by defining and applying additional mitigations, the documentation will be updated and the test re-run to verify the new process.
Both the IQ and the OQ must be developed, executed and have all required approvals…preferably before the software is deployed in a production environment.
The Performance Qualification (PQ)
The third qualification protocol, the PQ Performance Qualification is typically performed over an agreed period of time, once the software is being used in production and will focus on documenting, that your system performs consistently as intended over a period of time.
The above qualification protocols make up part of the documentation for the software validation. In the next blog, we’ll review what other documents you can expect to have developed as part of your Risk Based Software Validation.