ולידציה - Validation case study - part 2
The second part of our case study deals with the Validation Requirements of Documentation for Initial Tender,Documentation for Design Review,Documentation Pr…
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ולידציה - Validation case study - part 2 This article was written by Iian Shaya, validation,automation and control expert Validation Requirements Documentation for Initial Tender Project schedule and milestones design and construction detail Project quality plan Supplier’s local subsidiary/agent Supplier’s documentation that the system / configurable software versions are released to the market and are FDA/EMEA compliant Compliance to the 21 CFR Part 11 operational requirements – the contractor should ensure covering of all the requirements described below Contractor to state the system/product status and implementation planned for each requirement – User's approval pre-delivery Documentation for Design Review PID for the system Electrical and pneumatic schematics :Installation data General arrangement drawings Floor loading Utility requirements Details of electronic records and approvals that may be subject to regulatory controls under CFR Title 21 part 11 Instrumentation documentation :Main components specification Equipment Instrumentation Valves Piping Control system Pipe welding documentation General installation book Procedures User guide Security Preventative maintenance + spare parts list Operation procedure Pressure test procedure Leak test procedure Passivation procedure Calibration : Functional Design Specifications for Complete manufacturing system Software - SW and hardware - HW Functional Design Specifications System Detail Design Specifications for HW and SW. SW source code, with comments, for customized SW SW complete version history HMI alarm list, message list and graphical displays I/O list :List of materials Product contact materials Potential product contact lubricants Welding procedures for product direct and indirect contact parts Pre-delivery Inspection and Factory Acceptance Test (FAT) protocols Steel certificates and gasket certificates Documentation Prior to FAT or Pre-Delivery Inspection - PDI :Progress visit report which will include Mechanical and technical development Automation and SW development :Supplier’s factory test results for Unit tests - The test protocols shall be traced to low level design document and will be approved by the user prior to execution. The approval of the report shall be performed by representatives of the user's validation team, IT QA. Automation and SW development :Integration Tests - Simulation Testing Approved PDI and FAT protocols Commissioning MCCR Purpose Scope Responsibility Execution instructions System scope System description Drawing verification Equipment verification Valve verification Instrument installation and calibration Utility verification Documentations verification Piping Verification Sample Point Verification Safety, health and environment verification Slopes verification (if relevant) Electrical and communication activities Pump installation verification, if relevant Heat exchanger installation verification, if relevant Air break verification, if relevant Dead leg verification, if relevant CE Purpose Scope Responsibility Execution instructions System scope System description System startup Equipment verification Main equipment operation checks System FDS (SSO) verification System performance testing This article was written by Iian Shaya, validation,automation and control expert