IQ/OQ Validation

IQ/OQ Validation Package

What is the validation package?

The IQ/OQ validation package is a set of test script templates to be used with Freezerworks for installation and operational qualification validation. These scripts are constructed with a basic laboratory configuration that covers a wide range of metadata and security level testing across each functional feature of Freezerworks.

How do I use the scripts?

You can run the scripts as-is or modify them to meet requirements that may be mandated by your institution. For audit purposes, the executed scripts will provide a complete set of documented evidence of your Installation and Operational validation procedures.

What is the process?

There are 3 steps to the our standard validation sequence.

1. IQ, or Installation Qualification, refers to a set of tests that confirm the program has been installed correctly.

2. OQ, or Operational Qualification, tests that a program can operate and meet a customer’s basic configuration and functional needs.

3. PQ, or Performance Qualification, involves testing capabilities of workflows, complete system settings, users, security and so forth.

Why are test scripts important?

Providing test scripts for the first two steps vastly speeds up the process, making implementation faster and removing the need to create IQ and OQ scripts from scratch.

Consulting Options

Our IQ/OQ validation package also offers consulting in validation planning and strategies. This is ideal for customers who need to create an industry-standard validation plan if you don’t already have one in place, and enables you to know exactly what you should be testing and how thorough the testing should be.

Customer Care Program

The IQ/OQ Validation Package works in combination with the Freezerworks Customer Care Program. You can run the scripts on your own or purchase on-site help to assist with the validation process in conjunction with on-site training.

For more information about validation compliance, see Environment Testing.