The .csv files can be retrieved from the industrial PC through other devices on the network that the system is installed on – retrieval and management of the files from the industrial PC is the responsibility of the end user. Verification of data integrity transfer from the PanelView to the .csv file is provided in the FAT protocol (if the option is selected). This option is 21 CFR Part 11 compliant. − The following is included: ◊ One (1) Industrial PC – VersaView 6300B-BMADNA-AC8AW19NNNNNN-NN1S • DIN rail mounted inside system control panel • Windows operating system • Includes programming for logging and uploading of cleaning cycle and HMI audit trail data to the PC
NOTE: • This option requires the PanelView Plus 7 graphic terminal (running version 10 or higher of the FactoryTalk View Machine Edition [FT View ME] application).
• Custom System Automation (Hourly) – Custom System Automation requests can be integrated into the operation of the system. Defined custom requirements to be supplied during the detailed design of the project.
12.3 Documentation 12.3.1 Functional Specification (FS)
The Functional Specification (FS) is a detailed operational specification document and is provided in Sani-Matic’s standard format. 12.3.2 Configuration Specification (CS) The Configuration Specification (CS) is a detailed specification on the control components and software and is provided in Sani-Matic’s standard format. 12.3.3 Factory Acceptance Test (FAT) The Factory Acceptance Test (FAT) includes both the FAT protocol
document as well as the on-site FAT execution. The document is provided in Sani-Matic’s standard format. The FAT execution is performed and documented prior to shipment and includes up to four (4) days of on-site owner/user participation. Sani-Matic’s testing facilities include 460V AC, 3PH, 60Hz electrical power, compressed air, plant steam (as required), and low conductivity DI water allowing the system to be tested under design conditions. Testing will include a step-by-step written verification test of all electrical and hardware functions. Additional on-site owner/user time can be purchased if needed. 12.3.4 Site Acceptance Test (SAT) Document The Site Acceptance Test (SAT) document provides a detailed commissioning protocol to assist with the owner/user’s site acceptance testing, including step-by-step written verification testing of all electrical and mechanical hardware functions, and is provided in Sani-Matic’s standard format. 12.3.5 Installation Qualification / Operation Qualification (IQ/OQ) The Installation Qualification (IQ) and Operational Qualification (OQ) documents together provide a documented method for verification to ensure the system has been properly installed and that it is operating as designed. The document is provided in Sani-Matic’s standard format. 12.3.6 Instrument Data Sheets Instrument Data Sheets are provided for the instruments included with the system. The data sheets are provided in Sani-Matic’s standard format which is based on the ISA (International Society of Automation) format. 12.3.7 Traceability Matrix The Traceability Matrix document provides traceability of the system specifications in the FS, CS, FAT, SAT, and IQ/OQ documents back to an owner/user provided user requirements specification (URS). The traceability matrix is in Sani-Matic’s standard format and is provided after system shipment.
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