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
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