TD-0002_PharmaCab® SP_Technical Datasheet_Rev4.0

11.3 Documentation 11.3.1 Functional Specification (FS) The Functional Specification (FS) is a detailed operational specification document and is provided in Sani-Matic’s standard format 11.3.2 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 11.3.3 Factory Acceptance Test (FAT) The Factory Acceptance Test (FAT) includes both the FAT protocol document as well as the onsite 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 onsite 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 onsite owner/user time can be purchased if needed 11.3.4 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 11.3.5 Installation Qualification / Operational 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 11.3.6 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 11.3.7 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 11.3.8 Additional Turn Over Package (TOP) - Hard Copy An additional hard copy of the equipment Turn Over Package (TOP) will be printed and provided in a series of books (binders) All Documentation materials listed in Section 9 are included in the hard copy package

NOTE: • The Traceability Matrix will only contain traceability from the owner/user URS to the validation documents included in the system purchase

11.4 Field Service All pricing quoted are budgetary estimates based on the hours and expenses of the activity The invoice price is based on the ac- tual hours and expenses with a minimum eight (8) hours per day per technician (sum of both onsite and travel time) and with the expenses invoiced at Sani-Matic costs To minimize the time spent onsite and fully utilize the technician’s time, it is recommended that the equipment be fully installed and ready for operation prior to scheduling the technician’s trip

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TD-0002.4

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