The Pyro® eXpress Validation Protocols provide the end user with a comprehensive set of integrated documents to guide them through the system validation process. A Validation Plan outlines the tasks and documentation required to perform the validation. A Requirements Specification, the foundation of the validation process, clearly delineates the system's required functions and expected performance. Detailed instructions guide users step-by-step through the IQ/OQ, and PQ processes. Stress Test procedures are included as well as Change Control and Maintenance guides.
Pyros® eXpress Software Validation Protocols (Pyros Kinetix® Flex and Biotek ELx808 IU™)
Pyros® eXpress Software On-site Validation for Pyros Kinetix® Flex and ELx808 IU™