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 Systems
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