{"id":35600,"date":"2015-06-03T13:27:30","date_gmt":"2015-06-03T10:27:30","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35600"},"modified":"2015-06-03T13:27:30","modified_gmt":"2015-06-03T10:27:30","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-gamp-test-example-part-2","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-gamp-test-example-part-2\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 – GAMP – Test Example – part 2"},"content":{"rendered":"

Good Automated Manufacturing Practice (GAMP) – Test Example<\/h2>\n

Testing Process Automation Systems<\/h2>\n

This article cover \u00a0the second\u00a0part of \u00a0our \u00a0Good Automated Manufacturing Practice (GAMP)\u00a0test example. This part will cover \u00a0the typical test phases for supplier's\u00a0application SW<\/a> Module Testing, supplier's Module Integration Testing\u00a0and the\u00a0supplier's Integration Testing –\u00a0cont'd<\/p>\n

\u00a0\u00a0\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Typical Test Phases<\/h2>\n

\u00a0Typical 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.<\/p>\n

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.<\/p>\n

: Typical Test Phases for Process Automation S<\/strong>ystems<\/b><\/p>\n

\u00a0Supplier's Application SW Module Testing<\/strong> –<\/strong><\/p>\n

Done\u00a0at the Supplier's premises\u00a0after the module has been placed under configuration control and code reviewed. Before system integration.\u00a0Module testing generally covers: Module data handling<\/p>\n

\u00a0Interfaces to other modules<\/p>\n

\u00a0Operator interfaces<\/p>\n

\u00a0Module functionality Failure paths and response to fault conditions should be included within the tests<\/p>\n

Supplier's Module Integration Testing<\/strong> –<\/strong><\/p>\n

Done\u00a0at\u00a0the Supplier's premises.After individual module have been tested and integrated into a single unit.Before full system integration<\/p>\n

Module integration testing generally covers: Correct operation of Interfaces between modules<\/p>\n

Failure paths and response to fault conditions should be included within the tests<\/p>\n

Supplier's Integration Testing –<\/strong><\/p>\n

Done\u00a0at\u00a0the Supplier's premises.After module testing, and before the User is invited to witness the FAT<\/p>\n

Integration testing generally covers:<\/p>\n

\u00a0HW<\/p>\n

I\/O interfaces<\/p>\n

Operator interfaces<\/p>\n

Interfaces to other equipment<\/p>\n

System functionality<\/p>\n

Data handling functions<\/p>\n

Failure paths and response to fault conditions should be included within the tests<\/p>\n

:HW tests typically include<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Checking system build against approved HW specifications and drawings<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Recording system components, version numbers (including SW versions) and capacities<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0 Checking electrical supplies and grounding<\/p>\n

Supplier's Integration Testing (cont'd) –<\/strong><\/p>\n

Checking correct power up of system components<\/p>\n

Checking any self test\/diagnostic information<\/p>\n

Checking correct communication on standard interfaces<\/p>\n

:I\/O interface tests typically include<\/strong><\/p>\n

Exercising inputs and outputs to check correct configuration of ranges, alarms, etc.<\/p>\n

:Operator interface tests typically include<\/strong><\/p>\n

System displays and navigation<\/p>\n

Security and access controls<\/p>\n

:Tests for interfaces to other equipment typically include<\/strong><\/p>\n

Checks of communications protocol setup<\/p>\n

Checks that the required data can be transferred<\/p>\n

Checks of actions in case of communications failure<\/p>\n

Tests for system functionality typically include:<\/p>\n

Monitoring functions<\/p>\n

Alarm strategies<\/p>\n

Control functions)control modules, equipment modules, procedural control(<\/p>\n

Power failure and recovery<\/p>\n

Component failure and redundancy<\/p>\n

Performance checks<\/p>\n

:Tests for system data handling typically include<\/strong><\/p>\n

Operator data entry<\/p>\n

Data formatting and quality checks<\/p>\n

Checks of calculated values<\/p>\n

Checks of recipes<\/p>\n

Checks of access to current process data, alarms and events )displays, alarm summaries, etc.(<\/p>\n

Checks of access to historical process data, alarms and events )trends, reports, alarm histories, etc.(<\/p>\n

Checks of audit trail functionality<\/p>\n

Checks of data capacity and retention times<\/p>\n

Checks of archive and restore<\/p>\n

Checks of provisions for electronic signatures<\/p>\n

Checks of disaster recovery procedures<\/p>\n

End of \u00a0\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 – GAMP – Test Example – part 2<\/h2>\n

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