Whether you’re purchasing Freezerworks for the first time, or implementing a program update in a system that’s been running for years, best practices advocate testing the software in a way that ensures the safety and integrity of your live production data. In an FDA regulated environment that means having at least one other copy of Freezerworks as a test environment.1
GAMP® Guidelines classify Freezerworks as a Category 4 – Configured Product.2 As such, the test plan encompasses three elements: configuration, functionality, and requirements. The proper staging for that testing will be determined by your evaluation of the complexity and impact of Freezerworks to your system. Depending on that assessment, as well as your institution’s requirements, you may need up to three copies of Freezerworks to follow your validation procedures for commercial software. Test plan documents should specify and justify which of these environments will be used.
Development Environment – While most Freezerworks customers do not implement a development environment, your institution may require it. This environment is sometimes used to isolate testing of configuration items such as field definitions, user roles, and screen design. In lieu of a Development Environment, these activities are simply done in the Validation Environment.
Validation Environment – Where formal controlled testing is performed. This platform is as similar as possible to the production environment, but can be reset to restart testing as often as needed. Installation, Operational, and Performance Qualifications (IQ, OQ, and PQ) processes can all be safely performed here. (If you are unable to segregate a validation environment, contact your Freezerworks QA consultant for alternative strategies in designing your test plan.)
Production Environment – Where Freezerworks resides in its target environment containing live data.
Establishing separate environments for testing activities will not only help you satisfy FDA expectations and industry best practices, it will ensure the integrity and reliability of your live data.
Contact firstname.lastname@example.org for information and discount pricing on validation copies of Freezerworks.
For more information about saving time and resources in your validation projects, check out our IQ/OQ Validation Packages.
1 FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 6.1, January 2002
2 ISPE GAMP® Good Practice Guide: Testing of GxP Systems, Appendix T4, December 2005