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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:What are Qualification Protocols in Risk-Based Software Validation_IQS

  1. The Installation Qualification (IQ)
  2. The Operational Qualification (OQ)
  3. 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.

IQ Extract:

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.

OQ Extract:

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.

<<Read Part 4: Utilizing Scripts in Risk Based Software Validation
>>Read Part 6: Completing a Final Validation Package in Risk Based Software Validation


Michael Heaps

Michael Heaps was born and raised just outside of Manchester, in the United Kingdom. He started his first job for a computer manufacturing company at 20 years old, after completing a year-long technical college program in Computer Sciences and has been in the Manufacturing and Quality Management Software Industry for over 30 years. In 1998, the company Heaps worked for furthered their expansion and asked him to move to the United States with his family; his wife of 28 years, daughter and son. Heaps started working with IQS, Inc. full-time in 2008 to help provide Project Management Leadership and Customer Account Management. Since then his responsibilities have grown to include: VAR Channel Support and Development, IQS Validation Services and IQS Internal Quality Assurance and Release Management. Between the close-knit working environment and interaction among customers Heaps enjoys what he does for IQS, Inc. On a personal note, Heaps enjoys reading, camping and hiking and is heavily involved in supporting the local community theatre where his wife is the Business Manager. His children are now both grown with one working in the field of law and the other an Actor/Director.

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