Can Grand Avenue provide Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ) documentation?

Below is an excerpt from FDA’s General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

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Verification and validation apply directly to Grand Avenue Software (GAS) and are the terms used in our validation package.

The validation package is available for every Grand Avenue Software (GAS) release and can be downloaded from the GAS customer support website. Each customer has its own company-specific credentials for accessing these resources that can be obtained by contacting support@grandavenue.com.

The validation package for the current release is available directly from the “Software Releases” page. The validation packages for earlier versions of GAS are accessed by clicking the “Previous Validation Packages” link on the software releases page. 

An important item to note is the following sentence in ISO 13485:2016 section 4.1.6:

The specific approach and activities associated with software validation and re-validation shall be proportionate to the risk associated with the use of the software.

The validation package that comes with each release provides objective evidence that Grand Avenue

• Follows a defined Software Development Life Cycle (SDLC) using an agile methodology called Extreme Programming (XP)

• Verifies the functionality of new and existing software by continuously running automated unit tests

• Validates that new and existing software meets customer requirements by continuously running automated acceptance tests

• Manually tests that the software user interface meets specifications in every supported web browser

This information is intended to allow customers to make risk-based decisions about the level of GAS software validation to perform.

Rather than retesting what GAS has already tested, FDA expects manufacturers to leverage the testing documented in the validation package and focus validation on their intended use of the software, which means that they can use GAS as a tool to execute their quality system procedures and work instructions.