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X2570S-L Datasheet(PDF) 4 Page - Amphenol Corporation |
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X2570S-L Datasheet(HTML) 4 Page - Amphenol Corporation |
4 / 8 page 4 Reports The Kaye RF ValProbe Software includes an intuitive, yet powerful reporting utility for generating Set-Up, Calibration, Qualification, Graph and Calibration Verification reports to document validation study results. Reports are generated from secure data files that can only be read by the system software. Upon study completion, process cycles to be analyzed are defined using the intuitive system graphic feature. Qualification Reports present raw process data for individual sensors, statistical calculations selected during study setup, and accumulated lethality for individual sensors. Summary reports present study set-up details and poststudy user comments, along with group interval and lethality calculations, as well as data for each group and cycle. Use of the Summary and Group Summary Reports can greatly reduce the need to export data for manipulation in Excel®. Any action affecting user data can be permanently captured in a comprehensive audit trail, which can be automatically stored at a network location. System administrators can now have fully automated management of passwords, audit trails and data files across all validation groups. Summary Report Data files can be merged from multiple RF ValProbe and ValProbe studies. Users can add unlimited cycles, separating qualification data into specific process phases, and create up to 25 groups with their own calculations and graphs during reporting, A powerful graphing utility within the system software greatly simplifies process analysis and reporting. Sliding verticalaxesenabletheoperatortoflaganddefine process transition points, eliminating unnecessary reporting and streamlining the review process. The graphutilityfeaturesincreasedflexibilityforgraph customization, including specifying X and Y axis ranges, background colors, line styles and labeled limit lines. Graph report Security, Passwords and Audit Trails The Kaye RF ValProbe is specifically designed to enable compliance with FDA 21 CFR Part 11. All recorded data, including calibration offsets, set-up parameters, and administrative tasks are saved in secure, encrypted, tamper-proof electronic records in a format accessible only through the system software. All user inputs which could impact user data, for example starting a study or running a calibration, are protectedviasecureusername/passwordlogins,and are all logged in the secure audit trail database. Login Request |
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