ולידציה - 3 Validation case study - part
The third part of our Validation case study includes Documentation for IQ and OQ - to be checked at PDI/FAT, DQ Protocols Including PC/PLC, IQ Protocols Incl…
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ולידציה - 3 Validation case study - part This article was written by Iian Shaya, validation,automation and control expert Documentation for IQ and OQ - to be checked at PDI/FAT Welding reports Surfaces finishing test reports PDI and FAT results As-built drawings, 3 sets in nominated project language, plus 1 set in English As-installed versions of all documentation submitted for design review Back-up software on diskette/CD-ROM, as appropriate, ready for re-installment Machine configuration/start up, set-up and commissioning data, including tabulation of all change parts and identifications Full machine parts list Complete documentation (protocols and method statements) required for equipment DQ , calibration, IQ and OQ specified for manual and automatic operations Calibration certificates for all required instruments to NIST Specification for all parts manufactured by sub-contractors Full identification of all parts according to the P&ID, including valves, regulators, instruments, pipes, media and flow direction arrows Tags for electrical and pneumatic wiring Documentation to ensure qualification in compliance with FDA and EMEA, as outlined above DQ Protocols Including PC /PLC Approval Statement of purpose System description Traceability matrix IQ Protocols Including PC/ PLC Approval Statement of purpose System description Specifications Materials in product contact Engineering drawings Subsystem inspection Components Piping Valves Instrumentation and calibrations PC/ PLC requirement definition Software development documentation Manual / technical literature Test equipment data sheet Component data sheets Utility requirements Exceptional conditions, if required Summary OQ Protocols Including PC/ PLC Statement of purpose System description Manual and automatic control over all modules through HMI PC/ PLC validation protocols Step-by-step checking of schedule of system operation - SSO Alarm and message reaction HMI synoptic screen vs. P&ID System operation tests Operation tests for HMI to ensure compliance with 21 CFR part 11 Application software certification HW documentation SW code SW components data sheets HW components data sheets PLC configuration Graph printout Synoptic screen list and printout Operation screen list and printout Parameters list screen Messages and alarms list, and printout HW inspections SW inspections and application Approved schematic description Ladder diagram validation PLC capabilities PLC accuracy SW development documentation List of control devices Exceptional conditions Reports - verification of authorization inspection PQ Protocols Including PC/PLC Statement of purpose Analysis procedures Staff instruction Plan for sampling Criteria for acceptance This article was written by Iian Shaya, validation,automation and control expert