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. A CD containing the protocol files in Microsoft® Word format allows users to edit the documents to meet their company’s specific validation requirements.  Validation Protocols for 21 CFR Part 11 Compliant Software are available for the Pyros Kinetix tube reader with Pyros® EQS, the VersaMax Micro Plate Reader with SoftMax Pro Software and for the ELx808 Incubating Plate Reader with Gen5™ Secure Software.