ולידציה - GAMP - Test Example - part 2
This article cover the second part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for supplie…
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Good Automated Manufacturing Practice (GAMP) - Test Example Testing Process Automation Systems This article cover the second part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for supplier's application SW Module Testing, supplier's Module Integration Testing and the supplier's Integration Testing - cont'd Typical Test Phases Typical test phases for a complex process automation system. This example assumes that the system is configured by a Supplier and delivered to site after a FAT. Test system can also be configured by the system integrator or by the User. In this case, the same coverage is required, but the test phasing and location may be different. The User and Supplier should work together to develop an overall approach to testing that reflects the risk assessment output and ensures adequate test coverage of the functionality, whilst avoiding unnecessary repeated tests. : Typical Test Phases for Process Automation S ystems Supplier's Application SW Module Testing - Done at the Supplier's premises after the module has been placed under configuration control and code reviewed. Before system integration. Module testing generally covers: Module data handling Interfaces to other modules Operator interfaces Module functionality Failure paths and response to fault conditions should be included within the tests Supplier's Module Integration Testing - Done at the Supplier's premises.After individual module have been tested and integrated into a single unit.Before full system integration Module integration testing generally covers: Correct operation of Interfaces between modules Failure paths and response to fault conditions should be included within the tests Supplier's Integration Testing - Done at the Supplier's premises.After module testing, and before the User is invited to witness the FAT Integration testing generally covers: HW I/O interfaces Operator interfaces Interfaces to other equipment System functionality Data handling functions Failure paths and response to fault conditions should be included within the tests :HW tests typically include · Checking system build against approved HW specifications and drawings · Recording system components, version numbers (including SW versions) and capacities · Checking electrical supplies and grounding Supplier's Integration Testing (cont'd) - Checking correct power up of system components Checking any self test/diagnostic information Checking correct communication on standard interfaces : I/O interface tests typically include Exercising inputs and outputs to check correct configuration of ranges, alarms, etc. : Operator interface tests typically include System displays and navigation Security and access controls :Tests for interfaces to other equipment typically include Checks of communications protocol setup Checks that the required data can be transferred Checks of actions in case of communications failure Tests for system functionality typically include: Monitoring functions Alarm strategies Control functions)control modules, equipment modules, procedural control( Power failure and recovery Component failure and redundancy Performance checks :Tests for system data handling typically include Operator data entry Data formatting and quality checks Checks of calculated values Checks of recipes Checks of access to current process data, alarms and events )displays, alarm summaries, etc.( Checks of access to historical process data, alarms and events )trends, reports, alarm histories, etc.( Checks of audit trail functionality Checks of data capacity and retention times Checks of archive and restore Checks of provisions for electronic signatures Checks of disaster recovery procedures End of ולידציה - GAMP - Test Example - part 2