IQ/OQ Validation

Sample Management Software Validation Checklist

Looking at a lengthy timeline for validating Freezerworks in your regulated environment?

Let Freezerworks help cut that timeline significantly through our IQ/OQ 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.

Run the scripts as-is or modify them to meet other requirements that may be mandated by your institution. The executed scripts will provide a complete set of documented evidence of your Installation and Operational validation procedures for audit purposes

IQ and OQ are the first two of three steps in a standard validation sequence.

  • IQ, or Installation Qualification, refers to a set of tests that check that the program has been installed correctly
  • OQ, or Operational Qualification, tests that a program can operate and meet a customer’s basic configuration and functional needs

The third step, performance qualification (PQ), involves testing capabilities of workflows, complete system settings, users, security and so forth.

Providing test scripts for the first two steps should vastly speed up the process, allowing you to get to implementation much quicker, removing the need to create IQ and OQ scripts from scratch.

The Freezerworks IQ/OQ validation package also offers consulting in validation planning and strategies, a great help especially for customers needing to create an industry-standard validation plan if they don’t already have one in place. Know exactly what you should be testing and how thorough the testing should be.

The IQ/OQ Validation Package works in conjunction with the Freezerworks Customer Care program (CCP).  Run the scripts on your own, or purchase on-site help from Freezerworks to assist the validation process in conjunction with on-site training.

Contact for information and pricing. Find out how much time and resources the IQ/OQ validation package can save for you.

For more information about validation compliance, see Staging the Right Environments for Testing.