ValGenesis provides a pre-configured Operational Qualification (OQ) package and provides support to develop a Performance Qualification (PQ) package. The OQ is based on client specific configuration requirements, which must meet the stringent regulatory demands for software validation. These packages reduce the validation effort significantly. A critical part of the ValGenesis product is to offer superior validation support. The ValGenesis team can also help develop the overall plan for validation, create tailored scripts, assist with execution of test plans, and provide detailed documentation..

Automated Validation Framework

ValGenesis has developed an automation framework to validate ValGenesis instances. Using this framework the configured ValGenesis system can be validated automatically, including dynamic traceability matrix generation, dynamic test case generation and automated execution. Executed test cases are routed for review and approval, through controlled workflows available in ValGenesis. The entire validation process can be done within a few days.

Finally, ValGenesis automated validation framework can compile executed test cases into a single file, in PDF format, with all screenshots appended in the same document. The approved PDF document can be stored in client’s document management system. When audited by the FDA, or other governing bodies, validation reports are immediately available for review.