It is important to note that use by test facilities of the software programmes for these Test Guidelines is voluntary. That is, a test facility is not required to use the programmes to complete a test. However, if a test facility uses such a programme it must have the appropriately scaled validation documentation of risk assessment, user requirement specifications, acceptance testing records, and a listing in the computerised systems inventory. Currently, software programmes have been developed for four OECD Test Guidelines:
- Test No. 223: Avian Acute Oral Toxicity Test.
- Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure.
- Test No. 432: In Vitro 3T3 NRU Phototoxicity Test.
- Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists.
While these software programmes were not developed by OECD, they are referenced in the Test Guidelines, and can be downloaded for free on the OECD public website. These software programmes are provided as a courtesy of the developers of the test methods, but have not been validated, reviewed or approved by OECD. The developer, and not the OECD, should be described as the supplier of the software. In addition, the maintenance of the software or of the calculation sheets is not guaranteed by OECD. If a test facility does use one of these products, and if that facility wishes its test results to be compliant with OECD GLP, it must follow the guidance as described in Advisory Document 17 Application of GLP Principles to Computerised Systems. These software programmes are considered “Commercial Off-The-Shelf products (COTS)”, as described in OECD Advisory Document 17. Therefore, they require appropriate validation depending on the risk and the complexity of any customisation. If an application (e.g. a spreadsheet) is not complex, it might be sufficient to verify functions against user requirement specifications. In addition, user requirement specifications should be written for any application that is based on a COTS product. Documentation supplied with a COTS product should be verified by test facility management to ensure it is able to fulfill user requirement specifications. A test facility should perform a validation of a COTS software programme to ensure that it meets their needs, depending on prior validation by the provider. There must be documentation from the supplier that they have done the validation. Documentation must be available on the validation performed by the test facility. Therefore, if a test facility uses one of the software programmes to support data intended for a regulatory submission or to support a regulatory decision, and a validation has not been conducted by the vendor or documentation to support that validation is not available, there would be an expectation that the test facility would perform a full validation to ensure that it meets their needs as described in Advisory Document 17. Even if a validation has been conducted by the vendor, and documentation exists, it is still the test facilities’ responsibility to determine whether that is sufficient and, thus, further validation is not necessary. As mentioned above, the extent of the validation would likely depend upon prior validation (and documentation to support such a validation) as well as adaptation by the test facility (configuration) to meet their individual needs. And, if the user modifies the software programmes (customisation), there would be an expectation that the test facility would perform a full validation to ensure that it meets their individual needs. Documentation must be available on the full validation performed by the test facility.
